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临床试验/NCT06183788
NCT06183788招募中不适用

Antibody-mediated NMDA Receptor Encephalitis: Symptoms, Biomarkers, and Mechanisms of the Prolonged Recovery Stage

Fundacion Clinic per a la Recerca Biomédica2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
2
主要终点
Gender

研究概览

简要总结

The encephalitis mediated by antibodies against the NMDA receptor (NMDARe) predominantly affects young adults and children resulting in severe neurologic and psychiatric deficits. After overcoming the acute stage, patients are left with long-lasting behavioral, cognitive, and psychiatric alterations with important socio-family-economical implications. Here investigators postulate that a better knowledge of this stage will improve treatment decisions and outcome.

In Aim 1, the post-acute stage will be clinically characterized, tools to remotely follow cognitive, behavioral and psychiatric deficits will be provided, and the impact of cognitive rehabilitation will be assessed.

In Aim 2, biomarkers (autoimmune, inflammatory, neuronal injury) will be identified as signatures of the acute and post-acute stages.

In Aim 3, a mouse model of NMDARe will be used to determine the underlying mechanisms and treatment of the postacute stage.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ≥12 years old with NMDARe in the post-acute stage of the disease;
  • ≤6 months from hospital discharge (acute phase)

排除标准

  • (one of the following):
  • Inability to obtain informed consent;
  • inability to travel to the center.

结局指标

主要结局

Gender

时间窗: 18 months

Male or female

Allergies

时间窗: 18 months

List of allergies of each participant

Age

时间窗: 18 months

Age measured in years

Treatments

时间窗: 18 months

All treatments in which the participant is being involved.

Vision condition

时间窗: 18 months

Studied by optometer

Handedness

时间窗: 18 months

Right- or Left-handed

General medical history

时间窗: 18 months

Description of the most important issues compiled in the general medical history of the participant

Intelligence Quotient

时间窗: 18 months

Estimated through General Ability Index (GAI; from Weschler Adult Intelligence Scale - IV (WAIS-IV). This index is obtained through Verbal Comprehension Index (VCI) and Perceptual Reasoning Index (PRI). * Range of GAI: from 40 to 160. Higher is better. * Range of VCI: from 50 to 150. Higher is better. * Range of PRI: from 50 to 150. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Visual working memory

时间窗: 18 months

Visual Working Memory: Spatial location subtest from Weschler Memory Scale - IV (WMS-IV). \- Range of Spatial Location subtest: from 0 to 32. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Symptoms related to NMDARe

时间窗: 18 months

Detailed description of symptoms experienced before, during and after the post-acute phase of NMDARe.

HRT ISI Change - CPT3

时间窗: 18 months

Assessed by Continuous Performance Test - 3rd Version. Hit Reaction Time Inter-Stimulus Interval Change (HRT ISI Change) indicates the change in mean response speed at various ISIs. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Processing speed

时间窗: 18 months

Processing speed Index (PSI; from Weschler Adult Intelligence Scale - IV (WAIS-IV). Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Phonemic fluency

时间窗: 18 months

Number of words started by letter "M" recalled in 1 minute: Range: from 0 to infinity. (Test Barcelona-Revised) (for ADULTS) Number of words started by letter "P" recalled in 1 minute + number of words started by letter "M" in 1 minute: range: from 0 to infinity (NEPSY-II) (for CHILDREN). Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

HRT - CPT3

时间窗: 18 months

Assessed by Continuous Performance Test - 3rd Version. Hit Reaction Time (HRT) is the mean response speed of correct responses from the whole administration. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Variability- CPT3

时间窗: 18 months

Assessed by Continuous Performance Test - 3rd Version. The amount of variability that the patient showed in 18 separate segments of the administration in relation to their own overall Hit Reaction Time Standard Deviation (HRT-SD). It is a measure of response consistency and a "within respondent" measure". Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

HRT Block Change - CPT3

时间窗: 18 months

Assessed by Continuous Performance Test - 3rd Version. Hit Reaction Time Block Change indicates the change in mean response speed across blocks. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Detectability - CPT3

时间窗: 18 months

Assessed by Continuous Performance Test - 3rd Version. Measures the respondent's ability to differentiate non-targets (i.e. the letter X) from targets (i.e. all other letters). Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Omissions - CPT3

时间窗: 18 months

Assessed by Continuous Performance Test - 3rd Version. Result from a failure to respond to targets. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Semantic fluency

时间窗: 18 months

Number of name of animals recalled in 1 minute: range: from 0 to infinity. (Test Barcelona - Revised) (for ADULTS) Number of name of animals recalled in 1 minute + number of name of food and drinks recalled in 1 minute: from 0 to infinity (NEPSY - II) (for CHILDREN) Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

HRT-SD - CPT3

时间窗: 18 months

Assessed by Continuous Performance Test - 3rd Version. Hit Reaction Time Standard Deviation (HRT-SD) is a measure of response speed consistency during the entire administration. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Prensence of psychiatric symptoms or disorders in presential assessments

时间窗: 18 months

Number of participants with psychiatric symptoms/disorders following DSM-IV-TR guidelines (psychotic symptoms, symptoms of depression, symptoms of mania, global functioning).

Stroop test - color subtest

时间窗: 18 months

\- Colour: colours distinguished in 45 seconds. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Sleep microstructure - Delta arousals

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- "Delta arousals"?: yes, no or unknown

Comissions - CPT3

时间窗: 18 months

Assessed by Continuous Performance Test - 3rd Version. Comissions are made when responses are given to non-targets. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Sleep microstructure - First epoch of N2

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- First epoch of N2: minutes

Adherence to cognitive treatment - 6 months

时间窗: 6 months

Number of sessions performed in 6 months

Adherence to cognitive treatment - 9 months

时间窗: 9 months

Number of sessions performed in 9 months

Adherence to cognitive treatment - 12 months

时间窗: 12 months

Number of sessions performed in 12 months

Naming with cues

时间窗: 18 months

Assessed by: Boston Naming Test (BNT) \- Total correct with phonemic cue: from 0 to 60

Latency in naming

时间窗: 18 months

Assessed by: Boston Naming Test (BNT) \- Time to complete test in seconds

Proactive interference verbal memory

时间窗: 18 months

Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI) \- Interference list: range: 0 to 15. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Functional status

时间窗: 18 months

Functional status according to Modified Rankin Scale (mRS) Modified Rankin Scale: \- Range: from 0 points (no symptoms) to 6 points (dead).

Verbal working memory

时间窗: 18 months

Verbal Working Memory: Working Memory Index (WMI) from WAIS-IV. \- Range of WMI: from 50 to 150. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Phonological loop

时间窗: 18 months

Assessed by Forward order span of Digit span subtest from WAIS-IV. \- Range: from 0 to 9 Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Verbal learning

时间窗: 18 months

Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI) \- Total learning: range: from 0 to 80. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Short-term verbal memory

时间窗: 18 months

Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI) \- Short-term memory free recall: range: 0 to 15. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Visuospatial skills

时间窗: 18 months

Number location subtest of the Visual-Object Spatial and Perceptual battery. \- Range: from 0 to 10 Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Long-term verbal memory

时间窗: 18 months

Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI) \- Long-term memory free recall: range: 0 to 15. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Verbal recognition memory

时间窗: 18 months

Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI) \- Word-list Recognition: range: 0 to 15. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Naming

时间窗: 18 months

Assessed by: Boston Naming Test (BNT) \- Total correct: from 0 to 60 Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Verbal discrimination memory

时间窗: 18 months

Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI) \- Discrimination index of word-list: False positives + omissions of recognition between 44 total words to recognize. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Verbal retention memory

时间窗: 18 months

Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI) \- Retention index: percentatge of Long-term memory free recall between Short-term memory free recall. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Immediate visual memory

时间窗: 18 months

Assessed by: Brief Visuospatial Memory Test - Revised (BVMT-R) \- Immediate visual memory: range: from 0 to 36. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Delayed visual memory

时间窗: 18 months

Assessed by: Brief Visuospatial Memory Test - Revised (BVMT-R) \- Delayed visual memory: range: from 0 to 12. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Visual retention memory

时间窗: 18 months

Assessed by: Brief Visuospatial Memory Test - Revised (BVMT-R) \- Retention index: percentatge of Long-term memory free recall between the Higher punctuation at Trial 2 or 3. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Visual recognition memory

时间窗: 18 months

Assessed by: Brief Visuospatial Memory Test - Revised (BVMT-R) \- Figure Recognition: range: from 0 to 6. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Visual discrimination memory

时间窗: 18 months

Assessed by: Brief Visuospatial Memory Test - Revised (BVMT-R) \- Discrimination index: figure recognized minus false positives. Range: from -6 to 6. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

TMT-A

时间窗: 18 months

Trail Making Test part A (TMT-A): \- Time in seconds: from 0 to infinity. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

TMT-B

时间窗: 18 months

Trail Making Test part B (TMT-B): \- Time in seconds: from 0 to infinity. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Visuospatial skills - children

时间窗: 18 months

Assessed by Arrows subtest of NEPSY-2 battery \- Range: from 0 to 20 Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Stroop test - word subtest

时间窗: 18 months

\- Words: words read in 45 seconds Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Stroop test - word-color subtest

时间窗: 18 months

\- Word-colour: colours distinguished in 45 seconds. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.

Sleep microstructure - Total study time

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- Total sleep time: minutes

Sleep microstructure - Total sleep time

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- Total sleep time: minutes

Sleep microstructure - Sleep efficiency

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- Sleep efficiency: based on total study time and total sleep time

Sleep microstructure - Time to sleep onset

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- Time to sleep onset: minutes

Sleep microstructure - Time in stage N1

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- Time in stage N1: minutes

Sleep microstructure - Time in stage N2

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- Time in stage N2: minutes

Sleep microstructure - Time in stage N3

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- Time in stage N3: minutes

Sleep microstructure - Time in stage R

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- Time in stage R: minutes

Sleep microstructure - First epoch of N1

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- First epoch of N1: minutes

Sleep microstructure - First epoch of N3

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- First epoch of N3: minutes

Sleep microstructure - First epoch of REM

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- First epoch of REM: minutes

Sleep microstructure - REM/NREM time ratio

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- REM/NREM time ratio

Sleep microstructure - Number of arousals

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- Number of arousals (total)

Sleep microstructure - Arousal Index

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- Arousal Index

Sleep microstructure - Confusional arousals

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- Confusional arousals: Yes or No

Sleep microstructure - Direct transition from N3 to W

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- Direct transition from N3 to W: yes or no

Sleep microstructure - Wake after sleep

时间窗: 18 months

It will be adapted to patient's sleep habits (\~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: \- Wake after sleep: hour

次要结局

  • Cell immunophenotyping - proportion of plasmablasts(18 months)
  • Neurofilament light chain (NfL) levels in acute stage(18 months)
  • Cell immunophenotyping - proportion of CD8+CD45RO+(18 months)
  • Cell immunophenotyping - proportion of NK cells(18 months)
  • Neurofilament light chain (NfL) levels in post-acute stage(18 months)
  • Cell immunophenotyping - proportion of CD8(18 months)
  • Cell immunophenotyping - proportion of B naive (IgM+IgD+CD27-)(18 months)
  • Cell immunophenotyping - proportion of B memory (IgD-)(18 months)
  • Cell immunophenotyping - proportion of CD4(18 months)
  • Immune/inflammatory signaling-target gene expression pathways(18 months)
  • Cell immunophenotyping - proportion of CD8+CD45RA+(18 months)
  • Cell immunophenotyping - proportion of iNKT(18 months)
  • Cell immunophenotyping - proportion of CD19(18 months)
  • Cell immunophenotyping - proportion of regulatory B cells(18 months)
  • MRI(18 months)
  • Verbal learning - remote assessment(18 months)
  • Proactive interference verbal memory - remote assessment(18 months)
  • Time - Complex figure copy - remote assessment(18 months)
  • 5DT Choosing - remote assessment(18 months)
  • 5DT Switching - remote assessment(18 months)
  • Time in Naming - remote assessment(18 months)
  • 5DT Lecture - remote assessment(18 months)
  • Slow-wave rate of growth during slow-wave sleep period(18 months)
  • 5DT counting - remote assessment(18 months)
  • ERTTFAF - remote assessment(18 months)
  • 5DT Inhibition - remote assessment(18 months)
  • 5DT Flexibility - remote assessment(18 months)
  • Semantic fluency - remote assessment(18 months)
  • Psychiatric symptoms/disorders in remote assessments(18 months)
  • EEG reactivations in working memory(18 months)
  • Serial bias in working memory(18 months)
  • Phonemic fluency - remote assessment(18 months)
  • ERTTHD - remote assessment(18 months)
  • ERTTFAH - remote assessment(18 months)
  • ERTTFAS - remote assessment(18 months)
  • Type - Complex figure copy - remote assessment(18 months)
  • Short-term visual memory - remote assessment(18 months)
  • EEG: normalcy(18 months)
  • EEG: time awake(18 months)
  • EEG: time in drowsiness(18 months)
  • EEG: time asleep(18 months)
  • EEG: epileptiform activity(18 months)
  • EEG: seizures(18 months)
  • EEG: slowing(18 months)
  • EEG: Changes with Intermittent Light Stimulation(18 months)
  • EEG: Changes with hyperventilation(18 months)
  • Verbal working memory - remote assessment(18 months)
  • Short-term verbal memory - remote assessment(18 months)
  • Long-term verbal memory - remote assessment(18 months)
  • Verbal recognition memory - remote assessment(18 months)
  • Verbal discrimination memory - remote assessment(18 months)
  • Complex figure copy - remote assessment(18 months)
  • Long-term visual memory - remote assessment(18 months)
  • Orientation in time - remote assessment(18 months)
  • Orientation in space - remote assessment(18 months)
  • IEDEEDS - remote assessment(18 months)
  • IEDYERTA - remote assessment(18 months)
  • IEDYCOST - remote assessment(18 months)
  • SWM Total Errors - remote assessment(18 months)
  • SWM Between Errors - remote assessment(18 months)
  • SWM Within Errors - remote assessment(18 months)
  • SWM Double Errors - remote assessment(18 months)
  • SWMS - remote assessment(18 months)
  • SWMSX - remote assessment(18 months)
  • SWMPR - remote assessment(18 months)
  • ERTTH - remote assessment(18 months)
  • ERTTHH - remote assessment(18 months)
  • ERTTHS - remote assessment(18 months)
  • ERTTHF - remote assessment(18 months)
  • ERTTHA - remote assessment(18 months)
  • ERTTHSU - remote assessment(18 months)
  • ERTTFAA - remote assessment(18 months)
  • ERTTFASU - remote assessment(18 months)
  • ERTTFAD - remote assessment(18 months)
  • ERTUHRH - remote assessment(18 months)
  • ERTUHRS - remote assessment(18 months)
  • ERTUHRF - remote assessment(18 months)
  • ERTUHRA - remote assessment(18 months)
  • ERTUHRSU - remote assessment(18 months)
  • ERTUHRSD - remote assessment(18 months)
  • Naming - remote assessment(18 months)
  • Naming with cues - remote assessment(18 months)
  • Visuospatial skills - remote assessment(18 months)

研究者

发起方
Fundacion Clinic per a la Recerca Biomédica
申办方类型
Other
责任方
Sponsor

研究点 (2)

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