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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04817124
Other study ID # TrainStim4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 21, 2021
Est. completion date November 16, 2023

Study information

Verified date May 2024
Source University Medicine Greifswald
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training is feasible as a home-based intervention.


Description:

The goal of the present study is to assess feasibility (primary) and cognitive training and transfer effects of a home-based multi-session cognitive training combined with transcranial direct current stimulation (tDCS). tDCS, particularly in combination with cognitive training, represents a promising approach to counteract cognitive decline and restore impaired functions. However, combined interventions of cognitive training and tDCS involve frequent visits to the facility, which leads to the need of space, time and personnel, and imposes strains on the participants. This study will elucidate the feasibility of tDCS and cognitive training in a home-based context. Healthy older adults will participate in a two-week cognitive training with concurrent online tDCS application in their own homes. Feasibility, as well as cognitive performance 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. A Follow-up session to assess long-term effects is planned four weeks after the post assessment. We hypothesize that with appropriate training of the participants and close supervision the use of combined tDCS and cognitive training in an ecologically valid environment by the participants themselves is feasible. In addition, we hypothesize this protocol will lead to improved performance on the trained tasks in both experimental groups. We expect increased performance on transfer tasks and long-term maintenance of the effects after anodal compared to sham stimulation. A successful implementation of the intervention in the home-based setting will contribute to the development of home-based tDCS as a widely available therapy option in clinical populations.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 16, 2023
Est. primary completion date October 2, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria: 1. Age: 60 - 80 years 2. Right handedness Exclusion Criteria: 1. Neurodegenerative neurological illnesses, epilepsy or history of seizures 2. Severe and untreated medical conditions that preclude participation in the training, as determined by responsible physician 3. History of severe alcoholism or use of drugs 4. Severe psychiatric disorders such as depression (if not in remission) or psychosis 5. Contraindication to tDCS application

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Anodal tDCS
Anodal transcranial direct current stimulation (tDCS), 6 sessions with 20 minutes stimulation each (1,5 mA).
Behavioral:
Intensive cognitive training
Intensive cognitive training of a letter memory updating task, 6 sessions for approximately 20 min
Device:
Sham tDCS
Sham transcranial direct current stimulation (tDCS), 6 sessions with 30 sec stimulation each (1,5 mA) to ensure blinding of participants.

Locations

Country Name City State
Germany University Medicine Greifswald Greifswald

Sponsors (1)

Lead Sponsor Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of conducting the intervention in a home-based context Feasibility of home-based tDCS as operationalized by at least 2/3 (out of 6 planned sessions) successfully performed interventional sessions per participant. A session is regarded as successful if it is marked as completed in the stimulation system. 2 weeks
Secondary Feasibility (questionnaire) Self-rate questionnaire of participant satisfaction, independence and self-confidence in the handling of the devices and program (cf. Cha at el., 2016) after training period (anodal condition versus sham) 2 weeks
Secondary Working memory performance at post-assessment Performance in a near transfer task (n-back) under anodal tDCS compared to sham condition; operationalized by % correct responses in the n-back task 2 weeks
Secondary Working memory performance at follow-up assessment Performance in a near transfer task (n-back) under anodal tDCS compared to sham condition; operationalized by % correct responses in the n-back task 4 weeks after intervention
Secondary Working memory training performance (Letter Updating Task) at post-assessment Performance in primary memory training task (Letter Updating Task) at post-assessment, operationalized by number of correctly recalled lists in the letter updating task 2 weeks
Secondary Working memory training performance (Letter Updating Task) at follow-up assessment Performance in primary memory training task (Letter Updating Task) at follow-up assessment, operationalized by number of correctly recalled lists in the letter updating task 4 weeks after intervention
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