NCT04817124

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 21, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2023

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

2.4 years

First QC Date

March 24, 2021

Last Update Submit

May 8, 2024

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Feasibility (questionnaire)

    2 weeks

  • Working memory performance at post-assessment

    2 weeks

  • Working memory performance at follow-up assessment

    4 weeks after intervention

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

    2 weeks

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

    4 weeks after intervention

Study Arms (2)

stimulation group

EXPERIMENTAL

Anodal tDCS+ intensive cognitive Training

Device: Anodal tDCSBehavioral: Intensive cognitive training

sham group

SHAM COMPARATOR

Sham tDCS + intensive cognitive Training

Behavioral: Intensive cognitive trainingDevice: Sham tDCS

Interventions

Anodal tDCSDEVICE

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

stimulation group
Intensive cognitive trainingBEHAVIORAL

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

sham groupstimulation group
Sham tDCSDEVICE

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

sham group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 60 - 80 years
  • Right handedness

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine Greifswald

Greifswald, Germany

Location

Related Publications (1)

  • 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.

    PMID: 35688585DERIVED

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Agnes Flöel, Prof.

    University Medicine Greifswald

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 26, 2021

Study Start

May 21, 2021

Primary Completion

October 2, 2023

Study Completion

November 16, 2023

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations

DE(1)