Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke

Not Applicable

Completed

• Conditions: Stroke; Hemiparesis
• Interventions: Device: tDCS; Behavioral: Motor training

• Registration Number: NCT01969097
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-21
• Study First Posted: 2013-10-25
• Primary Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anodal tDCS + motor training	Motor training	Motor training of the affected upper extremity combined with anodal tDCS.
Dual tDCS + motor training	Motor training	Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS).
Sham tDCS + motor training	Motor training	Motor training of the affected upper extremity combined with sham tDCS.
Dual tDCS + motor training	tDCS	Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS).
Anodal tDCS + motor training	tDCS	Motor training of the affected upper extremity combined with anodal tDCS.
Sham tDCS + motor training	tDCS	Motor training of the affected upper extremity combined with sham tDCS.

Primary Outcome Measures

Name	Time	Method
Motor Function of the Affected Upper Extremity	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).

Secondary Outcome Measures

Name	Time	Method
Motor Function of the Affected Upper Extremity	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).
Functional Magnetic Resonance Imaging	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).
Diffusion Tensor Imaging	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).
Transcranial Magnetic Stimulation	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).

Trial Locations

Locations (1)

Charite Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany