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The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in individuals with prodromal Alzheimer's disease.
The goal of the present study is to assess behavioral (primary) effects of a multi-session cognitive training combined with transcranial direct current stimulation (tDCS). Many studies to date have found tDCS to be an efficient method to enhance various cognitive functions by modulating cortical excitability in young adults, but its behavioral impact and underlying mechanisms in pathological aging still need to be elucidated. Individuals with prodromal Alzheimer's disease, will participate in a three-week cognitive training with concurrent online tDCS application. Cognitive performance (primary) will be examined before, during and after the intervention, in order to draw conclusions about the effect of tDCS. In addition to cognitive training, a control group, receiving sham stimulation during training, will be assessed. Follow-up sessions to assess long-term effects are planned four weeks and seven months after the post assessment. Furthermore, to assess potential predictors of tDCS effects, functional and structural parameters will be measured with MRI. The results of the study will offer valuable insights into efficacy of combined tDCS and cognitive training, as compared to training alone, in individuals with prodromal stages of Alzheimer's disease. Moreover, improved understanding of tDCS effects on cognitive training performance and underlying neural correlates may help to develop novel approaches for modulating cognitive decline in healthy and pathological aging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation group | Experimental | Anodal tDCS + intensive cognitive training |
|
| Sham group | Sham Comparator | Sham tDCS + intensive cognitive training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anodal tDCS | Device | Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Working memory training performance (Letter Updating task) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Working memory training performance (Markov task) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medicine Greifswald | Greifswald | 17475 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38212815 | Derived | Antonenko D, Fromm AE, Thams F, Kuzmina A, Backhaus M, Knochenhauer E, Li SC, Grittner U, Floel A. Cognitive training and brain stimulation in patients with cognitive impairment: a randomized controlled trial. Alzheimers Res Ther. 2024 Jan 11;16(1):6. doi: 10.1186/s13195-024-01381-3. | |
| 33160420 | Derived | Thams F, Kuzmina A, Backhaus M, Li SC, Grittner U, Antonenko D, Floel A. Cognitive training and brain stimulation in prodromal Alzheimer's disease (AD-Stim)-study protocol for a double-blind randomized controlled phase IIb (monocenter) trial. Alzheimers Res Ther. 2020 Nov 7;12(1):142. doi: 10.1186/s13195-020-00692-5. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 18, 2022 | Jan 18, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Intensive cognitive training | Behavioral | Intensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions |
|
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) | Comparing performance immediately before and after training period (anodal condition versus sham) | 3 weeks |
| Transfer outcomes: Wiener Matrices Test (no. correct) | 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) | 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) | 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) | 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) | 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) | 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 | - 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 | - 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 |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |