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Completed

NCT Number: NCT04817124

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

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

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Key information

Conditions

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medicine Greifswald

Greifswald, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 60 - 80 years
  • Right handedness

Exclusion criteria

  • Neurodegenerative neurological illnesses, epilepsy or history of seizures
  • Severe and untreated medical conditions that preclude participation in the training, as determined by responsible physician
  • History of severe alcoholism or use of drugs
  • Severe psychiatric disorders such as depression (if not in remission) or psychosis
  • Contraindication to tDCS application

Treatment and study plan

Anodal tDCS

Device

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

Intensive cognitive training

Behavioral

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

Sham tDCS

Device

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

Primary outcomes

  1. Feasibility of conducting the intervention in a home-based context

    Time frame: 2 weeks

    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.

Secondary outcomes

  1. Feasibility (questionnaire)

    Time frame: 2 weeks

    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. Working memory performance at post-assessment

    Time frame: 2 weeks

    Performance in a near transfer task (n-back) under anodal tDCS compared to sham condition; operationalized by % correct responses in the n-back task

  3. Working memory performance at follow-up assessment

    Time frame: 4 weeks after intervention

    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. Working memory training performance (Letter Updating Task) at post-assessment

    Time frame: 2 weeks

    Performance in primary memory training task (Letter Updating Task) at post-assessment, operationalized by number of correctly recalled lists in the letter updating task

  5. Working memory training performance (Letter Updating Task) at follow-up assessment

    Time frame: 4 weeks after intervention

    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

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

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

Acronym: TrainStim4

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 26, 2021
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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