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Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke

Primary Purpose

Stroke, Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
tDCS
Motor training
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Hemiparesis, tDCS, Motor cortex

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charite Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Dual tDCS + motor training

Anodal tDCS + motor training

Sham tDCS + motor training

Arm Description

Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS).

Motor training of the affected upper extremity combined with anodal tDCS.

Motor training of the affected upper extremity combined with sham tDCS.

Outcomes

Primary Outcome Measures

Motor Function of the Affected Upper Extremity
Effects of dual tDCS + training vs sham-tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).
Motor Function of the Affected Upper Extremity
Effects of dual tDCS + training vs sham-tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).

Secondary Outcome Measures

Motor Function of the Affected Upper Extremity
Effects of dual tDCS + training vs anodal tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).
Functional Magnetic Resonance Imaging
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).
Diffusion Tensor Imaging
Effects of dual tDCS + training vs anodal tDCS + training vs sham-tDCS + training on cerebral microstructure (measured by Diffusion Tensor Imaging, DTI).
Transcranial Magnetic Stimulation
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).

Full Information

First Posted
October 7, 2013
Last Updated
March 16, 2016
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01969097
Brief Title
Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke
Official Title
Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
Stroke, Hemiparesis, tDCS, Motor cortex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dual tDCS + motor training
Arm Type
Experimental
Arm Description
Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS).
Arm Title
Anodal tDCS + motor training
Arm Type
Active Comparator
Arm Description
Motor training of the affected upper extremity combined with anodal tDCS.
Arm Title
Sham tDCS + motor training
Arm Type
Sham Comparator
Arm Description
Motor training of the affected upper extremity combined with sham tDCS.
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
transcranial direct current stimulation (tDCS)
Intervention Type
Behavioral
Intervention Name(s)
Motor training
Intervention Description
Motor training of the affected upper extremity (5 days, 25 min/day).
Primary Outcome Measure Information:
Title
Motor Function of the Affected Upper Extremity
Description
Effects of dual tDCS + training vs sham-tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).
Time Frame
Change from baseline after 5 days (immediately after intervention)
Title
Motor Function of the Affected Upper Extremity
Description
Effects of dual tDCS + training vs sham-tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).
Time Frame
change from baseline after 3 months
Secondary Outcome Measure Information:
Title
Motor Function of the Affected Upper Extremity
Description
Effects of dual tDCS + training vs anodal tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).
Time Frame
After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Title
Functional Magnetic Resonance Imaging
Description
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).
Time Frame
After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Title
Diffusion Tensor Imaging
Description
Effects of dual tDCS + training vs anodal tDCS + training vs sham-tDCS + training on cerebral microstructure (measured by Diffusion Tensor Imaging, DTI).
Time Frame
After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Title
Transcranial Magnetic Stimulation
Description
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).
Time Frame
After 5 days vs baseline (before intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Lindenberg, M.D.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21068427
Citation
Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.
Results Reference
background
PubMed Identifier
23699528
Citation
Lindenberg R, Nachtigall L, Meinzer M, Sieg MM, Floel A. Differential effects of dual and unihemispheric motor cortex stimulation in older adults. J Neurosci. 2013 May 22;33(21):9176-83. doi: 10.1523/JNEUROSCI.0055-13.2013.
Results Reference
background
PubMed Identifier
23727025
Citation
Floel A. tDCS-enhanced motor and cognitive function in neurological diseases. Neuroimage. 2014 Jan 15;85 Pt 3:934-47. doi: 10.1016/j.neuroimage.2013.05.098. Epub 2013 May 30.
Results Reference
background
PubMed Identifier
34858310
Citation
Taud B, Lindenberg R, Darkow R, Wevers J, Hofflin D, Grittner U, Meinzer M, Floel A. Limited Add-On Effects of Unilateral and Bilateral Transcranial Direct Current Stimulation on Visuo-Motor Grip Force Tracking Task Training Outcome in Chronic Stroke. A Randomized Controlled Trial. Front Neurol. 2021 Nov 11;12:736075. doi: 10.3389/fneur.2021.736075. eCollection 2021.
Results Reference
derived
PubMed Identifier
33175411
Citation
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Results Reference
derived

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Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke

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