- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04265378
Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease (AD-Stim)
Effects of Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease - Randomised, Sham Controlled, Interventional Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Greifswald, Germany, 17475
- University Medicine Greifswald
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Older adults (60 - 80 years);
- Right handedness;
- subjective cognitive decline (SCD) or mild cognitive impairment (MCI)
Exclusion Criteria:
- Dementia or other neurodegenerative neurological disorders; epilepsy or history of seizures; close relatives with epilepsy or history of seizures; previous stroke;
- Severe and untreated medical conditions that precludes participation in the training, as determined by responsible physician;
- History of severe alcoholism or use of drugs;
- Severe psychiatric disorders such as depression (if not in remission) or psychosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stimulation group
Anodal tDCS + intensive cognitive training
|
Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA)
Intensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions
|
Sham Comparator: Sham group
Sham tDCS + intensive cognitive training
|
Intensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Working memory training performance (Letter Updating task)
Time Frame: 3 weeks
|
Performance in a memory training task (Letter updating) under anodal tDCS compared to sham condition; operationalized by working Memory Updating performance assessed with number of correctly recalled letter lists in the letter updating task, analyzed immediately after training period (anodal condition versus sham)
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Working memory training performance (Markov task)
Time Frame: 3 weeks
|
Performance in second memory training task (Markov decision making) under anodal tDCS compared to sham condition, analyzed immediately after training period (anodal condition versus sham)
|
3 weeks
|
Transfer outcomes: numerical n-back task (% correct)
Time Frame: 3 weeks
|
Comparing performance immediately before and after training period (anodal condition versus sham)
|
3 weeks
|
Transfer outcomes: AVLT (auditory verbal learning test) (sum of correctly recalled items trials 1-5)
Time Frame: 3 weeks
|
Comparing performance immediately before and after training period (anodal condition versus sham)
|
3 weeks
|
Transfer outcomes: Wiener Matrices Test (no. correct)
Time Frame: 3 weeks
|
Comparing performance immediately before and after training period (anodal condition versus sham)
|
3 weeks
|
Long-term outcomes: Letter Updating task (no. of correctly recalled lists)
Time Frame: 4 weeks and 7 months after training
|
Comparing performance immediately before and after training period with performance at 4 weeks and 7-months after training period (anodal condition versus sham)
|
4 weeks and 7 months after training
|
Long-term outcomes: Markov decision making task (% optimal actions)
Time Frame: 4 weeks and 7 months after training
|
Comparing performance immediately before and after training period with performance at 4 weeks and 7-months after training period (anodal condition versus sham)
|
4 weeks and 7 months after training
|
Long-term outcomes: numerical n-back task (% correct)
Time Frame: 4 weeks and 7 months after training
|
Comparing performance immediately before and after training period with performance at 4 weeks and 7-months after training period (anodal condition versus sham)
|
4 weeks and 7 months after training
|
Long-term outcomes: AVLT (auditory verbal learning test) (sum of correctly recalled items trials 1-5)
Time Frame: 4 weeks and 7 months after training
|
Comparing performance immediately before and after training period with performance at 4 weeks and 7-months after training period (anodal condition versus sham)
|
4 weeks and 7 months after training
|
Long-term outcomes: Wiener Matrices Test (no. correct)
Time Frame: 4 weeks and 7 months after training
|
Comparing performance immediately before and after training period with performance at 4 weeks and 7-months after training period (anodal condition versus sham)
|
4 weeks and 7 months after training
|
Neural correlates: Structural neural correlates of tDCS effect
Time Frame: before training; 7 months after training
|
- structural neural correlates; assessed by grey matter volumes, cortical thickness, white matter microstructure (diffusion tensor imaging (DTI) measures: fractional anisotropy, mean diffusivity) before the intervention and at 7-months after training period (correlations in anodal group) |
before training; 7 months after training
|
Neural correlates: Functional neural correlates of tDCS effect
Time Frame: before training; 7 months after training
|
- functional neural correlates; assessed by resting-state fMRI analyses to obtain functional connectivities (seed-based connectivity: correlation of BOLD-timeseries between a seed/ROI and every voxel/location in the brain) before the intervention and at 7-months after training period (correlations in anodal group) |
before training; 7 months after training
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AD-Stim
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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