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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04817124
Acronym
TrainStim4
Enrollment
30
Registered
2021-03-26
Start date
2021-05-21
Completion date
2023-11-16
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Brief summary

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

Detailed 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.

Interventions

DEVICEAnodal tDCS

Anodal transcranial direct current stimulation (tDCS), 6 sessions with 20 minutes stimulation each (1,5 mA).

Intensive cognitive training of a letter memory updating task, 6 sessions for approximately 20 min

DEVICESham tDCS

Sham transcranial direct current stimulation (tDCS), 6 sessions with 30 sec stimulation each (1,5 mA) to ensure blinding of participants.

Sponsors

University Medicine Greifswald
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of conducting the intervention in a home-based context2 weeksFeasibility 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.

Secondary

MeasureTime frameDescription
Feasibility (questionnaire)2 weeksSelf-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)
Working memory performance at post-assessment2 weeksPerformance in a near transfer task (n-back) under anodal tDCS compared to sham condition; operationalized by % correct responses in the n-back task
Working memory performance at follow-up assessment4 weeks after interventionPerformance in a near transfer task (n-back) under anodal tDCS compared to sham condition; operationalized by % correct responses in the n-back task
Working memory training performance (Letter Updating Task) at post-assessment2 weeksPerformance in primary memory training task (Letter Updating Task) at post-assessment, operationalized by number of correctly recalled lists in the letter updating task
Working memory training performance (Letter Updating Task) at follow-up assessment4 weeks after interventionPerformance in primary memory training task (Letter Updating Task) at follow-up assessment, operationalized by number of correctly recalled lists in the letter updating task

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026