Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 7, 2013
CompletedFirst Posted
Study publicly available on registry
October 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedMarch 17, 2016
March 1, 2016
3.6 years
October 7, 2013
March 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
Change from baseline after 5 days (immediately after intervention)
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).
change from baseline after 3 months
Secondary Outcomes (4)
Motor Function of the Affected Upper Extremity
After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Functional Magnetic Resonance Imaging
After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Diffusion Tensor Imaging
After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Transcranial Magnetic Stimulation
After 5 days vs baseline (before intervention)
Study Arms (3)
Dual tDCS + motor training
EXPERIMENTALMotor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS).
Anodal tDCS + motor training
ACTIVE COMPARATORMotor training of the affected upper extremity combined with anodal tDCS.
Sham tDCS + motor training
SHAM COMPARATORMotor training of the affected upper extremity combined with sham tDCS.
Interventions
transcranial direct current stimulation (tDCS)
Motor training of the affected upper extremity (5 days, 25 min/day).
Eligibility Criteria
You may qualify if:
- chronic stroke (\>6 months after stroke)
- age: 18 to 80 years
- non-hemorrhagic or hemorrhagic stroke
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charite Universitätsmedizin Berlin
Berlin, 10117, Germany
Related Publications (5)
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.
PMID: 21068427BACKGROUNDLindenberg 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.
PMID: 23699528BACKGROUNDFloel 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.
PMID: 23727025BACKGROUNDTaud 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.
PMID: 34858310DERIVEDElsner 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.
PMID: 33175411DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Lindenberg, M.D.
Charite University, Berlin, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
October 7, 2013
First Posted
October 25, 2013
Study Start
May 1, 2012
Primary Completion
December 1, 2015
Last Updated
March 17, 2016
Record last verified: 2016-03