Transcranial Direct Current Stimulation for Post-stroke Gait Rehab
Primary Purpose
Stroke, Gait Impairment
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Active transcranial Direct Current Stimulation
Sham transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Gait therapy, transcranial Direct Current Stimulation (tDCS), Neuroplasticity, walking ability, brain stimulation, virtual reality
Eligibility Criteria
Inclusion Criteria:
- Medically and psychologically stable and at least 6 months after first ever unilateral stroke
- Cognition sufficiently intact to give valid informed consent to participate
- FMLE score >15; and ability to actively dorsiflex the paretic ankle in synergy (FMLE item II Flexor synergy-ankle dorsiflexion score 1).
- Sufficient endurance to participate in the study
Exclusion Criteria:
- Activity tolerance is insufficient to complete treadmill training
- Inability to produce a trace contraction of ankle dorsiflexors in synergy
- Normal ankle dorsiflexion/knee flexion on FMLE standing items (FMLE item IV score=4)
- Stroke affecting both sides
- Contraindications for rTMS according to the most recent TMS-use guidelines
- Contraindications for MRI
- Inability to understand English
Sites / Locations
- Louis Stokes VA Medical Center, Cleveland, OHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active tDCS
Sham tDCS
Arm Description
active tDCS plus gait training
sham tDCS plus gait training
Outcomes
Primary Outcome Measures
Change in Gait Speed from baseline
Gait speed will be calculated based on Ten Meter Walk Test
Secondary Outcome Measures
Full Information
NCT ID
NCT03666533
First Posted
September 4, 2018
Last Updated
October 10, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03666533
Brief Title
Transcranial Direct Current Stimulation for Post-stroke Gait Rehab
Official Title
Transcranial Direct Current Stimulation for Post-stroke Gait Rehab
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2018 (Actual)
Primary Completion Date
October 13, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Stroke affects upwards of 800,000 Americans every year and has an enormous impact on the well-being of the American Veteran population with 6,000 new stroke admissions every year. Many of these stroke survivors are living with walking disabilities. Gait problems result in inability to function independently, high risk of falls and poor quality of life. Unfortunately, current gait rehabilitation treatments are limited and many stroke survivors do not achieve full recovery. Therefore, it is critical to develop new approaches to enhance gait rehabilitation methods. The investigators propose to evaluate a brain stimulation treatment called transcranial Direct Current Stimulation (tDCS) that can be added to physical therapy. tDCS has been applied for arm rehabilitation after stroke with positive results, but gait-related investigations are lacking. The investigators will test whether simultaneous tDCS and gait training produces greater improvement in walking abilities than gait training alone. Adjunct tDCS therapy may improve outcomes, and reduce cost of both rehabilitation and post-stroke care.
Detailed Description
Current rehabilitation methods fail to restore normal gait for many stroke survivors leading to dependence on others, recurrent falls, limitations in community ambulation and poor quality of life. The main objective of this study is to test both efficacy and neurophysiological mechanisms of a novel approach to treat persistent gait deficits after stroke with a combination of simultaneous non-invasive brain stimulation with transcranial Direct Current Stimulation (tDCS) and gait training. The investigators will enroll chronic stroke subjects (>6 months) with gait deficits. Subjects will be randomized to 10 sessions of either active tDCS+gait training or sham tDCS+gait training. Gait training will be accomplished in the treadmill-based Virtual Reality environment targeting longer single limb stance with the paretic limb. The primary outcome measure will be both gait speed and single limb stance duration. Other outcome measures will assess various components of gait-related functional domains. The study will also characterize neuroplastic brain changes in response to bihemispheric tDCS combined with gait training based on corticospinal excitability using motor evoked potentials and functional connectivity using resting state functional Magnetic Resonance Imaging (rs-fMRI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Gait Impairment
Keywords
Gait therapy, transcranial Direct Current Stimulation (tDCS), Neuroplasticity, walking ability, brain stimulation, virtual reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
transcranial Direct Current Stimulation
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS
Arm Type
Active Comparator
Arm Description
active tDCS plus gait training
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
sham tDCS plus gait training
Intervention Type
Other
Intervention Name(s)
Active transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
Active tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy
Intervention Type
Other
Intervention Name(s)
Sham transcranial Direct Current Stimulation
Other Intervention Name(s)
Sham tDCS
Intervention Description
Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy
Primary Outcome Measure Information:
Title
Change in Gait Speed from baseline
Description
Gait speed will be calculated based on Ten Meter Walk Test
Time Frame
at 1-4 days after completion of 10-session intervention protocol
Other Pre-specified Outcome Measures:
Title
Change in Motor Evoked Potentials from baseline
Description
Measure of corticospinal excitability
Time Frame
at 1-4 days after completion of 10-session intervention protocol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Medically and psychologically stable and at least 6 months after first ever unilateral stroke
Cognition sufficiently intact to give valid informed consent to participate
FMLE score >15; and ability to actively dorsiflex the paretic ankle in synergy (FMLE item II Flexor synergy-ankle dorsiflexion score 1).
Sufficient endurance to participate in the study
Exclusion Criteria:
Activity tolerance is insufficient to complete treadmill training
Inability to produce a trace contraction of ankle dorsiflexors in synergy
Normal ankle dorsiflexion/knee flexion on FMLE standing items (FMLE item IV score=4)
Stroke affecting both sides
Contraindications for rTMS according to the most recent TMS-use guidelines
Contraindications for MRI
Inability to understand English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Holly B Henry
Phone
(216) 791-3800
Ext
64657
Email
holly.henry@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Neal S Peachey, PhD
Phone
(216) 421-3221
Email
neal.peachey@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svetlana Pundik, MD
Organizational Affiliation
Louis Stokes VA Medical Center, Cleveland, OH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Stokes VA Medical Center, Cleveland, OH
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-1702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica P McCabe, MPT DPT
Phone
216-791-3800
Ext
4691
Email
Jessica.Mccabe@va.gov
First Name & Middle Initial & Last Name & Degree
Svetlana Pundik, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Transcranial Direct Current Stimulation for Post-stroke Gait Rehab
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