Cognitive Decline Prognosis in Multiple Sclerosis: Effectiveness of a Computerized Cognitive Training Treatment on Cortical Reorganization
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in cortical connectivity as measured via EEG
研究概览
简要总结
This clinical study aims to identify MS related beneficial plasticity and by contrast maladaptive reorganization in combination with elements of daily functional status as a response to a cognitive training program
详细描述
Cognitive decline is a debilitating and widespread comorbidity of Multiple Sclerosis (MS) affecting up to 65 percent of patients with MS (PwMS). Cognitive changes can be the only behavioral index of MS activity. But how accurately and timely can these be captured? The existing clinical tools are subjective and do not have the dynamic of prognosis. It remains uncertain how much change in cognitive status is required to translate into a meaningful clinical outcome and how long it may subsequently take to become apparent. Moving towards a holistic approach, MS-NEUROPLAST aims to further expand previously-published prognostic marker candidates and previous work of the applicant and the members of the research team and employ a group of methodologies for interventions and applications which will quantify via real-world assessment the MS-related cognitive changes in order to characterize not only decline but given the right dosage of stimulation improvement as well.
MS-NEUROPLAST has three main objectives:
(i) Utilize state of-the-art neuroimaging and network science measures to more thoroughly understand neural indices of cognitive impairment in PwMS.
(ii) Evaluate the efficacy for treating MS-associated cognitive deficits using a computerized cognitive training treatment by determining the differences, between subjects treated with cognitive training and controls, on network science measures indexing network efficiency or collapse and on the performance of a battery of neuropsychological tests that are frequently impaired in MS.
(iii) Investigate the dissociation of the cortical mechanisms related to training-induced plasticity and maladaptive reorganization (namely separate good from bad), by taking into account the homeostatic capacity of the human organism as a whole and thus examining whether the correlation of the neurophysiological and cognitive indices with longitudinal digital biomarkers of daily functional status can capture the underlying pathology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for people with MS:
- •Male/female patients aged 18 to 65 years at screening
- •Diagnosis of MS according to the 2017 Revised McDonald criteria
- •Disability status at screening with an EDSS score of 0 to 6.5
- •Relapsing MS and progressive MS as defined by Lublin
- •Neurologically stable within 1 month prior to screening
- •Patients receiving the same Disease Modifying Treatment (DMT) for at least 6 months
排除标准
- •for people with MS:
- •Patients suspected of not being able or willing to cooperate or comply with study protocol requirements
- •Patients meeting criteria for other demyelinating diseases of the CNS
- •Patients with active chronic disease (or stable but treated with immune therapy) of the immune system other than MS
- •Patients with any other significant CNS disease or serious psychiatric disorder which can interfere with the patient's ability to cooperate or comply with the study procedure
- •Patients unable or unwilling to undergo MRI scans and EEG
- •Inclusion Criteria for Healthy Controls:
- •Normal hearing and normal or corrected-to-normal vision
- •Exclusion Criteria for Healthy Controls:
- •Any diagnosed neurological, mental, developmental, or psychiatric disorder
- •Unrecovered neurological disorders (i.e., stroke, traumatic brain injury)
- •Unstable medication within the last 3 months
- •Intake of central nervous drugs (e.g., antidepressants)
- •Severe physical disorder
- •Concurrent participation in another relevant study
- •Patients unable or unwilling to undergo EEG measurements
研究组 & 干预措施
PwMS-CON
Adult individuals with Multiple Sclerosis serving as active controls.
-
Neurological assessment
-
History of Multiple Sclerosis
-
Expanded Disability Status Scale (EDSS)
-
2 types of high-density electroencephalographic recordings
-
at rest with eyes closed (15 minutes)
-
event potentials via a multisensory oddball paradigm (45 minutes)
-
Neuropsychological assessment
-
Mini Mental Status Examination (MMSE)
-
Clock Drawing Test (CDT)
-
Greek Verbal Learning Test (GVLT)
-
Brief Visuospatial Memory Test (BVMT)
-
Symbol Digit Modalities Test (SDMT)
-
Verbal Fluency: Phonemic [ Chi-Sigma-Alpha] and Semantic [Animals-Fruits-Objects]
-
Digit Span (For-Back-Seq)_WAIS-4GR
-
Stroop Neuropsychological Test (SNST)
-
The Greek Accentuation Test (GAT)
-
DASS-21
-
MSIS-29
-
CRIq
-
MFIS
-
EQ-5D-5L
-
BDI-II
-
Somatometric assessment
-
T25-FW
-
3m backwards walk test
-
9-HPT
-
Handgrip Strength Test
-
SLS
-
FSST
-
Monitoring of dailty activity
干预措施: Monitoring of daily activity (Device)
PwMS-CCT
Adult individuals with Multiple Sclerosis will follow a cognitive training intervention.
-
Neurological assessment
-
History of Multiple Sclerosis
-
Expanded Disability Status Scale (EDSS)
-
2 types of high-density electroencephalographic recordings
-
at rest with eyes closed (15 minutes)
-
event potentials via a multisensory oddball paradigm (45 minutes)
-
Neuropsychological assessment
-
MMSE
-
CDT
-
GVLT
-
BVMT
-
SDMT
-
Verbal Fluency: Phonemic [ Chi-Sigma-Alpha] and Semantic [Animals-Fruits-Objects]
-
Digit Span (For-Back-Seq)_WAIS-4GR
-
SNST
-
GAT
-
DASS21
-
MSIS-29
-
CRIq
-
MFIS
-
EQ-5D-5L
-
BDI-II
-
Somatometric assessment
-
Timed 25-Foot Walk (T25-FW)
-
3m backwards walk test
-
Hole Peg Test (9-HPT)
-
Handgrip Strength Test
-
Single Leg Stance (SLS)
-
Four Square Step Test (FSST)
-
BrainHQ training
-
Monitoring of daily activity
干预措施: Cognitive Training (Other)
PwMS-CCT
Adult individuals with Multiple Sclerosis will follow a cognitive training intervention.
-
Neurological assessment
-
History of Multiple Sclerosis
-
Expanded Disability Status Scale (EDSS)
-
2 types of high-density electroencephalographic recordings
-
at rest with eyes closed (15 minutes)
-
event potentials via a multisensory oddball paradigm (45 minutes)
-
Neuropsychological assessment
-
MMSE
-
CDT
-
GVLT
-
BVMT
-
SDMT
-
Verbal Fluency: Phonemic [ Chi-Sigma-Alpha] and Semantic [Animals-Fruits-Objects]
-
Digit Span (For-Back-Seq)_WAIS-4GR
-
SNST
-
GAT
-
DASS21
-
MSIS-29
-
CRIq
-
MFIS
-
EQ-5D-5L
-
BDI-II
-
Somatometric assessment
-
Timed 25-Foot Walk (T25-FW)
-
3m backwards walk test
-
Hole Peg Test (9-HPT)
-
Handgrip Strength Test
-
Single Leg Stance (SLS)
-
Four Square Step Test (FSST)
-
BrainHQ training
-
Monitoring of daily activity
干预措施: Monitoring of daily activity (Device)
HC
Healthy adults serving as passive controls.
-
2 types of high-density electroencephalographic recordings
-
at rest with eyes closed (15 minutes)
-
event potentials via a multisensory oddball paradigm (45 minutes)
-
Neuropsychological assessment
-
Mini Mental Status Examination (MMSE)
-
Greek Verbal Learning Test (GVLT)
-
Brief Visuospatial Memory Test (BVMT)
-
Symbol Digit Modalities Test (SDMT)
-
Somatometric assessment
-
Timed 25-Foot Walk (T25-FW)
-
3m backwards walk test
-
Hole Peg Test (9-HPT)
-
Handgrip Strength Test
-
Single Leg Stance (SLS)
-
Four Square Step Test (FSST)
结局指标
主要结局
Change in cortical connectivity as measured via EEG
时间窗: 3 months
Changes in cortical connectivity caused via the training. Change is defined as statistical significance in the t-test comparison of Phase Transfer Entropy estimated from the cortical activity, as reconstructed via LORETA algorithm on the basis of high density EEG recordings, before compared to after the training.
Change in current density strength of the cortical activity as measured via EEG
时间窗: 3 months
Changes in cortical activity strength caused via the training. Change is defined as statistical significance in the t-test comparison of the current density strength as reconstructed via Low Resolution Electromagnetic Tomography (LORETA) algorithm on the basis of high-density EEG recordings, before compared to after the training.
Changes in the graph theory indexes as measured via EEG
时间窗: 3 months
Changes in the global and local graph theoretical indices of the brain networks caused via the training. Change is defined as statistical significance in the t-test comparison of the graph theory indices before compared to after the training.
次要结局
- Change in Digit Span (For-Back-Seq) _WAIS-4GR(3 months)
- Change in audiovisual integration functionality(3 months)
- Change in Mini Mental Status Examination (MMSE)(3 months)
- Change in Clock Drawing Test (CDT)(3 months)
- Change in Symbol Digit Modalities Test (SDMT)(3 months)
- Change in Depression Anxiety Stress Scale (DASS-21)(3 months)
- Change in Modified Fatigue Impact Scale (MFIS)(3 months)
- Change in EQ-5D-5L(3 months)
- Change in EQ-5D-5L -EQ-VAS(3 months)
- Change in Brief Visuospatial Memory Test (BVMT)(3 months)
- Change in Verbal Fluency: Semantic [Animals-Fruits-Objects](3 months)
- Change in Greek Accentuation Test (GAT)(3 months)
- Change in Hole Peg Test (9-HPT)(3 months)
- Change in 3 m backwards walk test(3 months)
- Change in Four Square Step Test (FSST)(3 months)
- Change in Verbal Fluency: Phonemic [ Chi-Sigma-Alpha](3 months)
- Change in Stroop Neuropsychological Test (SNST)(3 months)
- Change in Multiple Sclerosis Impact Scale (MSIS-29)(3 months)
- Change in the Cognitive Reserve Questionnaire (CRIq)(3 months)
- Change in Timed 25-Foot Walk (T25-FW)(3 months)
- Change in Single Leg Stance Test (SLS)(3 months)
- Change in the Handgrip Strength Test(3 months)
研究者
Panos Bamidis
Professor
Aristotle University Of Thessaloniki