Cognitive Training Combined With Transcranial Direct Current Stimulation in Older Adults in a Home-based Context

Aging Clinical Trial

— TrainStim4  

Official title:

Feasibility of Cognitive Training in Combination With Transcranial Direct Current Stimulation in a Home-based Context

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04817124
• Other study ID #: TrainStim4
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Aging

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