Back to resultsAnodal and Cathodal Transcranial Direct Current Stimulation in Stroke Recovery (tDCS)
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
transcranial direct current stimulation (Anodal)
transcranial direct current stimulation (Cathodal)
transcranial direct current stimulation (Sham)
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Ischemic stroke, direct current stimulation, motor threshold, National institutes of Health Stroke Scale, Barthel index scale, Measurement of motor power improvement
Eligibility 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
Sites / Locations
- Faculty of Medicine, Assiut University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
Anodal tDCS
Cathodal tDCS
Sham
Arm Description
Outcomes
Primary Outcome Measures
Motor power improvement
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
The difference in the motor cortical excitability (RMT, AMT) before and after tDCS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01601392
Brief Title
Anodal and Cathodal Transcranial Direct Current Stimulation in Stroke Recovery
Acronym
tDCS
Official Title
Effect of Anodal Versus Cathodal Transcranial Direct Current Stimulation on Stroke Recovery: a Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dina Hatem Elhammady
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Ischemic stroke, direct current stimulation, motor threshold, National institutes of Health Stroke Scale, Barthel index scale, Measurement of motor power improvement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anodal tDCS
Arm Type
Experimental
Arm Title
Cathodal tDCS
Arm Type
Active Comparator
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
transcranial direct current stimulation (Anodal)
Intervention Description
The anodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the affected hemisphere.
Intervention Type
Procedure
Intervention Name(s)
transcranial direct current stimulation (Cathodal)
Intervention Description
The Cathodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the unaffected hemisphere.
Intervention Type
Procedure
Intervention Name(s)
transcranial direct current stimulation (Sham)
Intervention Description
The sham group will receive sham tDCS for 25 minutes daily for 6 consecutive days on the affected hemisphere.
Primary Outcome Measure Information:
Title
Motor power improvement
Description
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).
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Motor cortical excitability
Description
The difference in the motor cortical excitability (RMT, AMT) before and after tDCS
Time Frame
1 Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman M Khedr, Professor
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Assiut University
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Anodal and Cathodal Transcranial Direct Current Stimulation in Stroke Recovery
We'll reach out to this number within 24 hrs