tDCS and Motor Training and Motor Deficit After Stroke

September 3, 2015 updated by: Tihomir Ilic, Military Medical Academy, Belgrade, Serbia

Effects of Anodal tDCS and Motor Training on Chronic Motor Deficit After Stroke

This study investigated the combined effects of anodal tDCS and intensive motor training (MT) vs. sham stimulation with MT (control intervention) on grip strength, motor performance and functional use of the affected arm in population of chronic stroke patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A growing body of evidence are available regarding the effectiveness of anodal transcranial direct current stimulation (tDCS) in patients with chronic hand motor impairment as a stroke consequence.

This study investigated the combined effects of anodal tDCS and intensive motor training (MT) vs. sham stimulation with MT (control intervention) on objective evaluation of fine and gross motor hand function using simulated activities of daily living (Jebsen-Taylor hand function test), grip strength, motor performance and functional use of the affected arm in this population of patients.

Patients with chronic hand motor deficits after stroke (> 12 months) are randomly assigned to active stimulation or a control intervention arm in a double-blinded, sham-controlled, parallel design. Each group received intensive MT for 45 min/day, 5 days/week, for 2 weeks, which was preceded by 20 minutes of 2 milliampere of anodal tDCS over the ipsilesional M1 vs. sham tDCS.

Outcome measures are tested at baseline (T0), and after the intervention Day 1 (T1), after stimulation protocol completion Day 10 (T2) and 30 days later (T3).

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 3

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

  • Serbia
      • Belgrade, Serbia, 11000
        • Clinic of Neurology, Military Medical Academy, Belgrade

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of stroke made by clinical features and documented by neuroimaging studies (CT or MRI scans
  • stroke duration > 12 months
  • severe hand deficit at stroke onset (Medical Research Council grade <2) and
  • subsequently recovered to the level moderate hand deficit with presence of hand movements evaluated by the Fugl-Meyer upper-extremity Assessment (FMA) of Motor Recovery after Stroke between 28-50 points (max. 66 pts),
  • spasticity between 0-2 assessed on the Modified Ashworth Scale

Exclusion Criteria:

  • any clinically significant or unstable medical disorder,
  • diagnosis od major depression,
  • diagnosis odf substance or alcohol abuse or any neurological disorder other than stroke, including neglect, aphasia, hemianopsia and serious cognitive impairment (Mini-Mental State Examination < 24).
  • any contraindications to tDCS, including histories of seizure, cerebral aneurysm, and prior surgery involving metallic implants

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active treatment
Group of patients on active treatment will receive intensive motor training for 45 min/day, 5 days/week, for 2 weeks, which would be preceded by 20 minutes of 2 mA anodal tDCS over the ipsilesional motor cortex.
Device: tDCS (Endomed 482; Enraf-Nonius B.V.)
non-invasive brain stimulation with pair of electrodes with saline-soaked pads through which the direct current of intensity of 2 mA is delivered
Sham Comparator: Sham comparator
Group of patients on sham treatment will receive intensive motor training for 45 min/day, 5 days/week, for 2 weeks, which would be preceded by sham tDCS over the ipsilesional motor cortex.
Device: tDCS (Endomed 482; Enraf-Nonius B.V.)
non-invasive brain stimulation with pair of electrodes with saline-soaked pads through which the direct current of intensity of 2 mA is delivered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Jebsen Taylor Test of Hand Function
Time Frame: one day, two weeks and one month
changes of baseline summed times to complete six individual tasks (from JTT-2 to JTT7) and is performed with each hand separately
one day, two weeks and one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hand grip force
Time Frame: two weeks and one month
changes of baseline maximum grip force of the hand measured by whole-hand dynamometer
two weeks and one month
upper limb Fugl-Meyer assessment of Motor Recovery after Stroke
Time Frame: one day, two weeks and one month
changes of initial score from domain of motor functions for upper limb
one day, two weeks and one month

Collaborators and Investigators

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

Sponsor

Military Medical Academy, Belgrade, Serbia

Collaborators

Clinical Centre of Serbia

Investigators

  • Principal Investigator: Tihomir V Ilic, MD, PhD, Military Medical Academy, Serbia

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

April 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 21, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 3, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFVMA/12/13-15

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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