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

Feasibility of Cognitive Training in Combination With Transcranial Direct Current Stimulation 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.

Study Overview

• Status: Recruiting
• Conditions: Aging
• Intervention / Treatment: Device: Anodal tDCS; Behavioral: Intensive cognitive training; Device: Sham tDCS

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agnes Flöel, Prof.; Phone Number: 0049 3834 86 6815; Email: agnes.floeel@med.uni-greifswald.de
• Study Contact Backup: Name: Daria Antonenko, Dr.; Phone Number: 0049 3834 86 6754; Email: daria.antonenko@med.uni-greifswald.de

Study Locations

• Germany
  • Greifswald, Germany
    • Recruiting
    • University Medicine Greifswald
    • Contact: Agnes Flöel, Prof.; Phone Number: 0049 3834 86 6815; Email: agnes.floeel@med.uni-greifswald.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stimulation group; Anodal tDCS+ intensive cognitive Training	Device: Anodal tDCS; Anodal transcranial direct current stimulation (tDCS), 6 sessions with 20 minutes stimulation each (1,5 mA).; Behavioral: Intensive cognitive training; Intensive cognitive training of a letter memory updating task, 6 sessions for approximately 20 min
Sham Comparator: sham group; Sham tDCS + intensive cognitive Training	Behavioral: Intensive cognitive training; Intensive cognitive training of a letter memory updating task, 6 sessions for approximately 20 min; Device: Sham tDCS; Sham transcranial direct current stimulation (tDCS), 6 sessions with 30 sec stimulation each (1,5 mA) to ensure blinding of participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of conducting the intervention in a home-based context	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.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility (questionnaire)	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 weeks
Working memory performance at post-assessment	Performance in a near transfer task (n-back) under anodal tDCS compared to sham condition; operationalized by % correct responses in the n-back task	2 weeks
Working memory performance at follow-up assessment	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 weeks after intervention
Working memory training performance (Letter Updating Task) at post-assessment	Performance in primary memory training task (Letter Updating Task) at post-assessment, operationalized by number of correctly recalled lists in the letter updating task	2 weeks
Working memory training performance (Letter Updating Task) at follow-up assessment	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	4 weeks after intervention

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Investigators: Study Director: Agnes Flöel, Prof., University Medicine Greifswald

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TrainStim4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No