NCT01601392

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 18, 2012

Status Verified

May 1, 2012

Enrollment Period

1.3 years

First QC Date

May 11, 2012

Last Update Submit

May 16, 2012

Conditions

Stroke

Keywords

Ischemic strokedirect current stimulationmotor thresholdNational institutes of Health Stroke ScaleBarthel index scaleMeasurement of motor power improvement

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Motor cortical excitability

    1 Month

Study Arms (3)

Anodal tDCS

EXPERIMENTAL
Procedure: transcranial direct current stimulation (Anodal)

Cathodal tDCS

ACTIVE COMPARATOR
Procedure: transcranial direct current stimulation (Cathodal)

Sham

SHAM COMPARATOR
Procedure: transcranial direct current stimulation (Sham)

Interventions

transcranial direct current stimulation (Anodal)PROCEDURE

The anodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the affected hemisphere.

Anodal tDCS
transcranial direct current stimulation (Cathodal)PROCEDURE

The Cathodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the unaffected hemisphere.

Cathodal tDCS
transcranial direct current stimulation (Sham)PROCEDURE

The sham group will receive sham tDCS for 25 minutes daily for 6 consecutive days on the affected hemisphere.

Sham

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute hemiparesis with single thromboembolic non-hemorrhagic infarction documented by magnetic resonance imaging (MRI)
  • Accept to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Assiut University

Asyut, Asyut Governorate, Egypt

Location

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

Transcranial Direct Current Stimulationsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Eman M Khedr, Professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 11, 2012

First Posted

May 18, 2012

Study Start

January 1, 2011

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

May 18, 2012

Record last verified: 2012-05

Locations

EG(1)