Clincosm LogoSign in Get a demo

Transcranial Direct Current Stimulation Aided Rehabilitation of Gait in Subacute Stroke

Sponsor
University of Aarhus (Other)
Overall Status
Terminated
CT.gov ID
NCT01927458
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
33
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Direct Current Stimulation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximal gait speed using the 10-m walking test [Baseline and follow up immediately following the 4 weeks intervention]

    Secondary Outcome Measures

    1. Changes in cortical excitability measures [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.

    2. Dynamometry: the maximal isometric force of muscles will be assessed by Biodex System 3 PRO dynamometer [Baseline and immediately following the 4 weeks intervention]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hammel Neurocenter Hammel Denmark 8450

    Sponsors and Collaborators

    • University of Aarhus

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Krystian Figlewski, MD, University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT01927458
    Other Study ID Numbers:
    • M-2012-570-12
    First Posted:
    Aug 22, 2013
    Last Update Posted:
    Feb 7, 2017
    Last Verified:
    Feb 1, 2017
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of Feb 7, 2017