Anodal and Cathodal Transcranial Direct Current Stimulation in Stroke Recovery (tDCS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Assiut University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Dina Hatem Elhammady
Information provided by (Responsible Party):
Dina Hatem Elhammady, Assiut University
ClinicalTrials.gov Identifier:
NCT01601392
First received: May 11, 2012
Last updated: May 16, 2012
Last verified: May 2012
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 Assiut University:
Primary Outcome Measures:
- Motor power improvement [ Time Frame: 3 Months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01601392
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Dina Hatem Elhammady, Clinical Professor, Assiut University |
| ClinicalTrials.gov Identifier: | NCT01601392 History of Changes |
| Other Study ID Numbers: | tDCS in stroke recovery |
| Study First Received: | May 11, 2012 |
| Last Updated: | May 16, 2012 |
| Health Authority: | Egypt: Ministry of Higher Education |
Keywords provided by 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 Brain Diseases Cardiovascular Diseases Central Nervous System Diseases |
Cerebrovascular Disorders Nervous System Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on February 27, 2015