Anodal and Cathodal Transcranial Direct Current Stimulation in Stroke Recovery (tDCS)
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| ClinicalTrials.gov Identifier: NCT01601392 |
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Recruitment Status : Unknown
Verified May 2012 by Dina Hatem Elhammady, Assiut University.
Recruitment status was: Active, not recruiting
First Posted : May 18, 2012
Last Update Posted : May 18, 2012
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Sponsor:
Dina Hatem Elhammady
Information provided by (Responsible Party):
Dina Hatem Elhammady, Assiut University
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Stroke | Procedure: transcranial direct current stimulation (Anodal) Procedure: transcranial direct current stimulation (Cathodal) Procedure: transcranial direct current stimulation (Sham) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| 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 |
| Study Start Date : | January 2011 |
| Estimated Primary Completion Date : | May 2012 |
| Estimated Study Completion Date : | June 2012 |
| Arm | Intervention/treatment |
|---|---|
| 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. |
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
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| Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
| 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
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 |
| 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 Posted: | May 18, 2012 Key Record Dates |
| Last Update Posted: | May 18, 2012 |
| Last Verified: | May 2012 |
Keywords provided by Dina Hatem Elhammady, Assiut University:
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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:
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Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |