Clinical trial NCT04817124: Cognitive Training Combined With Transcranial Direct Current Stimulation in Older Adults in a Home-based Context
Official title: Feasibility of Cognitive Training in Combination With Transcranial Direct Current Stimulation in a Home-based Context
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of conducting the intervention in a home-based context
timeFrame: 2 weeks
Secondary outcomes:
measure: Feasibility (questionnaire)
timeFrame: 2 weeks
measure: Working memory performance at post-assessment
timeFrame: 2 weeks
measure: Working memory performance at follow-up assessment
timeFrame: 4 weeks after intervention
measure: Working memory training performance (Letter Updating Task) at post-assessment
timeFrame: 2 weeks
measure: Working memory training performance (Letter Updating Task) at follow-up assessment
timeFrame: 4 weeks after intervention
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
Study officials:
affiliation: University Medicine Greifswald
name: Agnes Flöel, Prof.
role: STUDY_DIRECTOR
References:
citation: Thams F, Rocke M, Malinowski R, Nowak R, Grittner U, Antonenko D, Floel A. Feasibility of Cognitive Training in Combination With Transcranial Direct Current Stimulation in a Home-Based Context (TrainStim-Home): study protocol for a randomised controlled trial. BMJ Open. 2022 Jun 10;12(6):e059943. doi: 10.1136/bmjopen-2021-059943.