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临床试验/NCT06501755
NCT06501755尚未招募不适用

Effects and Mechanisms of Action of an Individualized Theta Frequency Transcranial Alternating Current Stimulation (ITF-tACS) on a Working Memory Training at Healthy Older Adults With Subjective Cognitive Decline (SCD)

University Hospital Tuebingen2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
36
试验地点
2
主要终点
Reaction time in the spatial 2-, 3-, 4-back at the post-session

研究概览

简要总结

The aim of the study is to investigate the effects and mechanisms of action of an individualized transcranial alternating current stimulation in the theta-range (ITF-tACS) on a three day spatial working memory training in healthy older adults with subjective cognitive decline (SCD).

详细描述

This study uses a randomized, double-blind, two-armed, sham-controlled between-subjects design. It is conducted at the University Hospital for Psychiatry and Psychotherapy Tübingen, Germany. Participants older than 60 years and with subjective cognitive decline (SCD) will be included. Other inclusion and exclusion criteria are displayed under "Eligibility". Participants are recruited via email-newsletters at the University of Tübingen, flyers and newspaper advertisement. Participants will receive financial compensation. A stratified block randomization is applied after the inclusion of the participants and before the baseline-session. The person generating the randomization list is not involved with data collection. Operators do not have access to the randomization list during the data collection.

Sample size is N = 36 with n = 18 participants in each group. As a phase 2 study, the aim of this study is the determination of effect sizes which can be used for further investigations. Thus due to a lack of comparable studies, no power analysis could be conducted. The group size is therefore based on the most frequently found group size (n = 18) observed in a systematic review regarding the effects of tACS targeting the memory in healthy adults.

The study includes seven time points: screening-session, baseline-session (in the end of the first week of data-collection), three training sessions (within the second week of data-collection, each session two days apart), post-session (10-12 days after the baseline-session; in the beginning of the third week of data-collection) and follow-up session (one month after the post-session). Online tACS is applied during the training sessions while the participants will conduct an adaptive spatial n-back task (online stimulation). Resting-state EEG as well as EEGs during the spatial 2-, 3-, 4-back at the baseline- and the post-session are conducted. Two groups are compared: one group with individualized theta-tACS (ITF-tACS) and one with sham-tACS.

Hypothesis H1 contains the effect on the trained task (spatial 2-, 3-, 4-back) at the post-session. The investigators expect a higher performance in the group with ITF-tACS compared to sham-tACS. To test this hypothesis, two ANCOVAs (dependent variable = performance at post-session (Reaction time and d prime, Covariate = performance at baseline-session) will be conducted.

Hypothesis H2.1 contains the effect on the trained task in the training sessions concurrent to the tACS. The investigators expect a higher performance in the group with ITF-tACS compared to sham-tACS in all sessions. To test the hypothesis, a linear mixed model will be conducted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • age >/= 60 years
  • subjective cognitive decline with a duration > 6 month and without a concrete cause
  • right-handedness (score > 48 in the Edinburgh Handedness Inventory (EHI; Oldfield, 1971))
  • corrected or sufficient eyesight
  • sufficient knowledge in German
  • ability to consent

排除标准

  • neuropsychiatric diagnose
  • score > 13 in the DemTect (Kalbe et al., 2019)
  • score > 4 in the Geriatric Depression Scale Short Form (GDS-SF; Sheikh & Yesavage, 1986)
  • score > 16 Geriatric Anxiety Scale German version(GAS-G; Gottschling et al., 2016)
  • substance abuse or dependence
  • epileptic seizure in medical history
  • metall in skalp-area
  • pacemaker
  • gravidity
  • psychiatric medication
  • benzodiazepines in a dosage > 1 mg Lorazepam
  • participation in a tACS in history

结局指标

主要结局

Reaction time in the spatial 2-, 3-, 4-back at the post-session

时间窗: Post-session (10-12 days after the baseline-session)

Reaction times \< 150ms and \> M + 3 SD after visual inspection via histogram and box plot per participant will be excluded from the analysis

d prime in the spatial 2-, 3-, 4-back at the post-session

时间窗: Post-session (10-12 days after the baseline-session)

d prime = z(Hits) - z(False Alarms)

次要结局

  • Reaction time in the adaptive spatial n-back during the trainingssessions(Trainingssessions (conducted in the week after the baseline-session with each 2 days apart))
  • d prime in the spatial 2-, 3-, 4-back at the follow-up session(Follow-up session (1 month after the post-session))
  • Sumscores in the digit span task at the post-session(Post-session (10-12 days after the baseline-session))
  • Reaction time in the spatial 2-, 3-, 4-back at the follow-up session(Follow-up session (1 month after the post-session))
  • Score on a 10-point likert scale about the worries on cognitive abilities at the post-session(Post-session (10-12 days after the baseline-session))
  • Theta-power in the EEG at the post-session(Post-session (10-12 days after the baseline-session))
  • Connectivity of the front-parietal network in the EEG at the post-session(Post-session (10-12 days after the baseline-session))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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