Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke

Stroke Clinical Trial

Official title:

Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969097
• Other study ID #: MotorCtx-Stroke-tDCS
• Status: Completed
• Phase: N/A
• First received: October 7, 2013
• Last updated: March 16, 2016
• Start date: May 2012

Study information

• Verified date: March 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiparesis
• Stroke

Intervention

Device:
• tDCS
transcranial direct current stimulation (tDCS)

Behavioral:
• Motor training
Motor training of the affected upper extremity (5 days, 25 min/day).

Locations

Country	Name	City	State
Germany	Charite Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Flöel 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. Review. — View Citation

Lindenberg R, Nachtigall L, Meinzer M, Sieg MM, Flöel 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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	No
Secondary	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).	After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)	No
Secondary	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).	After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)	No
Secondary	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).	After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)	No
Secondary	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).	After 5 days vs baseline (before intervention)	No