Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke

NCT ID: NCT01969097

Last Updated: 2016-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Brief Summary

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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

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Conditions

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Stroke Hemiparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dual tDCS + motor training

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

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

transcranial direct current stimulation (tDCS)

Motor training

Intervention Type BEHAVIORAL

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

Anodal tDCS + motor training

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

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type DEVICE

transcranial direct current stimulation (tDCS)

Motor training

Intervention Type BEHAVIORAL

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

Sham tDCS + motor training

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

Group Type SHAM_COMPARATOR

tDCS

Intervention Type DEVICE

transcranial direct current stimulation (tDCS)

Motor training

Intervention Type BEHAVIORAL

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

Interventions

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tDCS

transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Motor training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Agnes Flöel

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Lindenberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charite Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 21068427 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23699528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23727025 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34858310 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33175411 (View on PubMed)

Other Identifiers

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MotorCtx-Stroke-tDCS

Identifier Type: -

Identifier Source: org_study_id

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