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

May 16, 2012 updated by: Dina Hatem Elhammady

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Faculty of Medicine, Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor power improvement
Time Frame: 3 Months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor cortical excitability
Time Frame: 1 Month
The difference in the motor cortical excitability (RMT, AMT) before and after tDCS
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dina Hatem Elhammady

Investigators

  • Principal Investigator: Eman M Khedr, Professor, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

May 11, 2012

First Submitted That Met QC Criteria

May 16, 2012

First Posted (Estimate)

May 18, 2012

Study Record Updates

Last Update Posted (Estimate)

May 18, 2012

Last Update Submitted That Met QC Criteria

May 16, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tDCS in stroke recovery

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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