Clinical trial NCT01969097: Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke
Official title: Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis
Keywords: Stroke
Hemiparesis
tDCS
Motor cortex
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-10-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Motor Function of the Affected Upper Extremity
timeFrame: Change from baseline after 5 days (immediately after intervention)
measure: Motor Function of the Affected Upper Extremity
timeFrame: change from baseline after 3 months
Secondary outcomes:
measure: Motor Function of the Affected Upper Extremity
timeFrame: After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
measure: Functional Magnetic Resonance Imaging
timeFrame: After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
measure: Diffusion Tensor Imaging
timeFrame: After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
measure: Transcranial Magnetic Stimulation
timeFrame: After 5 days vs baseline (before intervention)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Robert Lindenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.