Transcranial Direct Current Stimulation Aided Rehabilitation of Gait in Subacute Stroke

February 4, 2017 updated by: Krystian Figlewski, University of Aarhus
The purpose of this study is to determine if transcranial direct current stimulation (tDCS)applied over the lower extremity motor cortex in conjunction with treadmill training is effective for improving gait in patients with subacute stroke and to evaluate the effect and predictive value of a single session of anodal tDCS.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

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

  • Denmark
      • Hammel, Denmark, 8450
        • Hammel Neurocenter

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Onset of stroke less than 14 days
  • First ischemic stroke causing lower limb weakness (MRC score ≤4 in knee extensors) and gait impairment

Exclusion Criteria:

  • Contraindications to MRI or TMS
  • Other neurological disorders
  • Significant somatic or psychiatric disorders
  • History of seizures
  • Language or cognitive disorders prohibiting participation

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: anodal tDCS with treadmill training
Each subject will receive 4 weeks gait treadmill training at least 3 days per week in combination with anodal transcranial Direct Current Stimulation over the primary motor cortex up to 20 min
Device: Transcranial Direct Current Stimulation
A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue
Other Names:
  • Non.invasive brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal gait speed using the 10-m walking test
Time Frame: Baseline and follow up immediately following the 4 weeks intervention
Baseline and follow up immediately following the 4 weeks intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in cortical excitability measures
Time Frame: Baseline
We will measure cortical excitability using single pulse transcranial magnetic stimulation (TMS) before and after 1st stimulation session. We will compare the measurements from before stimulation to after stimulation.
Baseline
Dynamometry: the maximal isometric force of muscles will be assessed by Biodex System 3 PRO dynamometer
Time Frame: Baseline and immediately following the 4 weeks intervention
Baseline and immediately following the 4 weeks intervention

Collaborators and Investigators

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

Sponsor

University of Aarhus

Investigators

  • Study Director: Henning Andersen, Professor, University of Aarhus

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

March 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (Estimate)

August 22, 2013

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 4, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-2012-570-12

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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