Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke

March 16, 2016 updated by: Agnes Flöel, Charite University, Berlin, Germany
The aim of the study is to investigate whether the combination of bihemispheric ("dual") transcranial direct current stimulation (tDCS) and motor training on 5 consecutive days facilitates motor recovery in chronic stroke. Results will be compared to a matched group of patients undergoing anodal tDCS as well as a control group receiving sham tDCS. Functional and structural magnetic resonance imaging (MRI) before/after the intervention and during a 3 month follow-up will help investigating neural correlates of expected changes in motor function of the affected upper extremity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charite Universitatsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic stroke (>6 months after stroke)
  • age: 18 to 80 years
  • non-hemorrhagic or hemorrhagic stroke

Exclusion Criteria:

  • more than 1 stroke
  • severe alcohol disease or drug abuse, severe psychiatric disease like depression or psychosis
  • severe cognitive deficits
  • severe untreated medical conditions
  • other neurologic diseases
  • severe microangiopathy
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dual tDCS + motor training
Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS).
Device: tDCS
transcranial direct current stimulation (tDCS)
Behavioral: Motor training
Motor training of the affected upper extremity (5 days, 25 min/day).
Active Comparator: Anodal tDCS + motor training
Motor training of the affected upper extremity combined with anodal tDCS.
Device: tDCS
transcranial direct current stimulation (tDCS)
Behavioral: Motor training
Motor training of the affected upper extremity (5 days, 25 min/day).
Sham Comparator: Sham tDCS + motor training
Motor training of the affected upper extremity combined with sham tDCS.
Device: tDCS
transcranial direct current stimulation (tDCS)
Behavioral: Motor training
Motor training of the affected upper extremity (5 days, 25 min/day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor Function of the Affected Upper Extremity
Time Frame: Change from baseline after 5 days (immediately after intervention)
Effects of dual tDCS + training vs sham-tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).
Change from baseline after 5 days (immediately after intervention)
Motor Function of the Affected Upper Extremity
Time Frame: change from baseline after 3 months
Effects of dual tDCS + training vs sham-tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).
change from baseline after 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor Function of the Affected Upper Extremity
Time Frame: After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Effects of dual tDCS + training vs anodal tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).
After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Functional Magnetic Resonance Imaging
Time Frame: After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Effects of dual tDCS + training vs anodal tDCS + training vs sham-tDCS + training on task-specific activations and functional connectivity (measured by functional Magnetic Resonance Imaging, fMRI).
After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Diffusion Tensor Imaging
Time Frame: After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Effects of dual tDCS + training vs anodal tDCS + training vs sham-tDCS + training on cerebral microstructure (measured by Diffusion Tensor Imaging, DTI).
After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Transcranial Magnetic Stimulation
Time Frame: After 5 days vs baseline (before intervention)
Effects of dual tDCS + training vs anodal tDCS + training vs sham tDCS + training on excitability of the primary motor cortex (measured by Motor Evoked Potentials, MEP, using Transcranial Magnetic Stimulation, TMS).
After 5 days vs baseline (before intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Robert Lindenberg, M.D., Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (Estimate)

October 25, 2013

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 16, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MotorCtx-Stroke-tDCS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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