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Cognitive Training Combined With Transcranial Direct Current Stimulation in Older Adults in a Home-based Context (TrainStim4)

U

University Medicine Greifswald

Status

Completed

Conditions

Aging

Treatments

Device: Sham tDCS
Behavioral: Intensive cognitive training
Device: Anodal tDCS

Study type

Interventional

Funder types

Other

Identifiers

NCT04817124
TrainStim4

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Ages

60 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

stimulation group
Experimental group
Description:
Anodal tDCS+ intensive cognitive Training
Treatment:
Device: Anodal tDCS
Behavioral: Intensive cognitive training
sham group
Sham Comparator group
Description:
Sham tDCS + intensive cognitive Training
Treatment:
Device: Sham tDCS
Behavioral: Intensive cognitive training

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Daria Antonenko, Dr.; Agnes Flöel, Prof.

Data sourced from clinicaltrials.gov

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