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

This study is ongoing, but not recruiting participants.
Sponsor:
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

May 11, 2012
May 16, 2012
January 2011
May 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01601392 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Anodal and Cathodal Transcranial Direct Current Stimulation in Stroke Recovery
Effect of Anodal Versus Cathodal Transcranial Direct Current Stimulation on Stroke Recovery: a Pilot Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stroke
  • 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.
  • 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.
  • 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.
  • Experimental: Anodal tDCS
    Intervention: Procedure: transcranial direct current stimulation (Anodal)
  • Active Comparator: Cathodal tDCS
    Intervention: Procedure: transcranial direct current stimulation (Cathodal)
  • Sham Comparator: Sham
    Intervention: Procedure: transcranial direct current stimulation (Sham)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
June 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01601392
tDCS in stroke recovery
Not Provided
Dina Hatem Elhammady, Assiut University
Dina Hatem Elhammady
Not Provided
Principal Investigator: Eman M Khedr, Professor Assiut University
Assiut University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP