Back to resultsTranscranial Direct Current Stimulation Aided Rehabilitation of Gait in Subacute Stroke
Primary Purpose
Stroke, Neurorehabilitation
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional other trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Hammel Neurocenter
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
anodal tDCS with treadmill training
Arm Description
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
Outcomes
Primary Outcome Measures
Maximal gait speed using the 10-m walking test
Secondary Outcome Measures
Changes in cortical excitability measures
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.
Dynamometry: the maximal isometric force of muscles will be assessed by Biodex System 3 PRO dynamometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01927458
Brief Title
Transcranial Direct Current Stimulation Aided Rehabilitation of Gait in Subacute Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment rate
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Neurorehabilitation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
anodal tDCS with treadmill training
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
Non.invasive brain stimulation
Intervention Description
A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue
Primary Outcome Measure Information:
Title
Maximal gait speed using the 10-m walking test
Time Frame
Baseline and follow up immediately following the 4 weeks intervention
Secondary Outcome Measure Information:
Title
Changes in cortical excitability measures
Description
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.
Time Frame
Baseline
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Andersen, Professor
Organizational Affiliation
University of Aarhus
Official's Role
Study Director
Facility Information:
Facility Name
Hammel Neurocenter
City
Hammel
ZIP/Postal Code
8450
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Transcranial Direct Current Stimulation Aided Rehabilitation of Gait in Subacute Stroke
We'll reach out to this number within 24 hrs