Anodal and Cathodal Transcranial Direct Current Stimulation in Stroke Recovery (tDCS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified May 2012 by Dina Hatem Elhammady, Assiut University.
Recruitment status was: Active, not recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01601392

First Posted: May 18, 2012

Last Update Posted: May 18, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Dina Hatem Elhammady, Assiut University

Purpose

The purpose of this study will to compare the long-term effect of anodal versus cathodal transcranial direct current stimulation (tDCS) on motor recovery in subacute stroke patients. Forty patients with subacute ischemic stroke will randomly assigned to one of three groups: Anodal, Cathodal and Sham. Each group will receive tDCS at an intensity of 2mA for 25 minutes daily for 6 consecutive days over the affected (Anodal, Sham) or unaffected (Cathodal) motor cortex. Patients will be assessed with National Institutes of Health Stroke Scale (NIHSS), the Barthel index (BI) and the Medical Research Council (MRC) muscle strength scale at baseline, after end of the 6th tDCS session, and then 1, 2 and 3 months later. Motor cortical excitability will be measured at baseline and after the 6th session in both hemispheres.

Condition	Intervention
Stroke	Procedure: transcranial direct current stimulation (Anodal) Procedure: transcranial direct current stimulation (Cathodal) Procedure: transcranial direct current stimulation (Sham)


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Effect of Anodal Versus Cathodal Transcranial Direct Current Stimulation on Stroke Recovery: a Pilot Randomized Controlled Trial

Further study details as provided by Dina Hatem Elhammady, Assiut University:

Primary Outcome Measures:

Motor power improvement [ Time Frame: 3 Months ]
improvement in the motor power of paretic patient as measured in one proximal and one distal muscle group testing in upper (shoulder abduction + hand grip) and lower limbs ( hip flexion + toes dorsiflexion).

Secondary Outcome Measures:

Motor cortical excitability [ Time Frame: 1 Month ]
The difference in the motor cortical excitability (RMT, AMT) before and after tDCS


Enrollment:	40
Study Start Date:	January 2011
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Anodal tDCS	Procedure: transcranial direct current stimulation (Anodal) The anodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the affected hemisphere.
Active Comparator: Cathodal tDCS	Procedure: transcranial direct current stimulation (Cathodal) The Cathodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the unaffected hemisphere.
Sham Comparator: Sham	Procedure: transcranial direct current stimulation (Sham) The sham group will receive sham tDCS for 25 minutes daily for 6 consecutive days on the affected hemisphere.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	40 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

acute hemiparesis with single thromboembolic non-hemorrhagic infarction documented by magnetic resonance imaging (MRI)
Accept to participate in the study

Exclusion Criteria:

extensive infarction (taking all territories of middle cerebral artery)
severe flaccid hemiplegia
head injury
Any other neurological disease other than stroke
previous administration of tranquilizer
patients who are unable to give informed consent because of severe aphasia, or cognitive deficit.
Patients with no motor evoked response recorded from First Dorsal Interosseus (FDI) muscle of the affected hand

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601392

Locations


Egypt
Faculty of Medicine, Assiut University
Assiut, Egypt

Sponsors and Collaborators

Dina Hatem Elhammady

Investigators


Principal Investigator:	Eman M Khedr, Professor	Assiut University

More Information


Responsible Party:	Dina Hatem Elhammady, Clinical Professor, Assiut University
ClinicalTrials.gov Identifier:	NCT01601392 History of Changes
Other Study ID Numbers:	tDCS in stroke recovery
First Submitted:	May 11, 2012
First Posted:	May 18, 2012
Last Update Posted:	May 18, 2012
Last Verified:	May 2012

Keywords provided by Dina Hatem Elhammady, Assiut University:


Ischemic stroke direct current stimulation motor threshold	National institutes of Health Stroke Scale Barthel index scale Measurement of motor power improvement

Additional relevant MeSH terms:


Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases	Nervous System Diseases Vascular Diseases Cardiovascular Diseases

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