Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease (AD-Stim)

November 3, 2022 updated by: University Medicine Greifswald

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Greifswald, Germany, 17475
        • University Medicine Greifswald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Device: anodal tDCS
Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA)
Behavioral: Intensive cognitive training
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
Behavioral: 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

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

October 10, 2022

Study Completion (Actual)

October 10, 2022

Study Registration Dates

First Submitted

February 3, 2020

First Submitted That Met QC Criteria

February 7, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2022

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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