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

NCT ID: NCT04817124

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-21

Study Completion Date

2023-11-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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stimulation group

Anodal tDCS+ intensive cognitive Training

Group Type EXPERIMENTAL

Anodal tDCS

Intervention Type DEVICE

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

Intensive cognitive training

Intervention Type BEHAVIORAL

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

sham group

Sham tDCS + intensive cognitive Training

Group Type SHAM_COMPARATOR

Intensive cognitive training

Intervention Type BEHAVIORAL

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

Sham tDCS

Intervention Type DEVICE

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

Interventions

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Anodal tDCS

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

Intervention Type DEVICE

Intensive cognitive training

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

Intervention Type BEHAVIORAL

Sham tDCS

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Agnes Flöel, Prof.

Role: STUDY_DIRECTOR

University Medicine Greifswald

Locations

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University Medicine Greifswald

Greifswald, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 35688585 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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TrainStim4

Identifier Type: -

Identifier Source: org_study_id

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