Anodal and Cathodal Transcranial Direct Current Stimulation in Stroke Recovery

Stroke Clinical Trial

— tDCS  

Official title:

Effect of Anodal Versus Cathodal Transcranial Direct Current Stimulation on Stroke Recovery: a Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01601392
• Other study ID #: tDCS in stroke recovery
• Status: Active, not recruiting
• Phase: N/A
• First received: May 11, 2012
• Last updated: May 16, 2012
• Start date: January 2011
• Est. completion date: June 2012

Study information

• Verified date: May 2012
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.
• transcranial direct current stimulation (Sham)
The sham group will receive sham tDCS for 25 minutes daily for 6 consecutive days on the affected hemisphere.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Dina Hatem Elhammady

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3 Months	No
Secondary	Motor cortical excitability	The difference in the motor cortical excitability (RMT, AMT) before and after tDCS	1 Month	No