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Completed

NCT Number: NCT04265378

Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease

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.

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Key information

Conditions

Subjective Cognitive Decline Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment Neurocognitive Disorders

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medicine Greifswald

Greifswald, 17475, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anodal tDCS

Device

Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA)

Intensive cognitive training

Behavioral

Intensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Transfer outcomes: numerical n-back task (% correct)

    Time frame: 3 weeks

    Comparing performance immediately before and after training period (anodal condition versus sham)

  3. 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)

  4. Transfer outcomes: Wiener Matrices Test (no. correct)

    Time frame: 3 weeks

    Comparing performance immediately before and after training period (anodal condition versus sham)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

Effects of Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease - Randomised, Sham Controlled, Interventional Study

Acronym: AD-Stim

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2020
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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