Overview

This trial is active, not recruiting.

Condition stroke
Treatments transcranial direct current stimulation (anodal), transcranial direct current stimulation (cathodal), transcranial direct current stimulation (sham)
Sponsor Dina Hatem Elhammady
Start date January 2011
End date May 2012
Trial size 40 participants
Trial identifier NCT01601392, tDCS in stroke recovery

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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)
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)
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 Outcomes

Measure
Motor power improvement
time frame: 3 Months

Secondary Outcomes

Measure
Motor cortical excitability
time frame: 1 Month

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

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

Additional Information

Official title Effect of Anodal Versus Cathodal Transcranial Direct Current Stimulation on Stroke Recovery: a Pilot Randomized Controlled Trial
Principal investigator Eman M Khedr, Professor
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Assiut University.