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Trial record 2 of 5 for:    Pundik | Stroke

Transcranial Direct Current Stimulation for Post-stroke Gait Rehab

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ClinicalTrials.gov Identifier: NCT03666533
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Stroke Gait Impairment Other: Active transcranial Direct Current Stimulation Other: Sham transcranial Direct Current Stimulation Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: transcranial Direct Current Stimulation
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation for Post-stroke Gait Rehab
Actual Study Start Date : September 13, 2018
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Active tDCS
active tDCS plus gait training
Other: Active transcranial Direct Current Stimulation
Active tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy
Other Name: tDCS

Sham Comparator: Sham tDCS
sham tDCS plus gait training
Other: Sham transcranial Direct Current Stimulation
Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy
Other Name: Sham tDCS




Primary Outcome Measures :
  1. Change in Gait Speed from baseline [ Time Frame: at 1-4 days after completion of 10-session intervention protocol ]
    Gait speed will be calculated based on Ten Meter Walk Test


Other Outcome Measures:
  1. Change in Motor Evoked Potentials from baseline [ Time Frame: at 1-4 days after completion of 10-session intervention protocol ]
    Measure of corticospinal excitability



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666533


Contacts
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Contact: Holly B Henry (216) 791-3800 ext 64657 holly.henry@va.gov
Contact: Neal S Peachey, PhD (216) 421-3221 neal.peachey@va.gov

Locations
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United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jessica P McCabe, MPT    216-791-3800 ext 4691    jessicapmccabe@hotmail.com   
Principal Investigator: Svetlana Pundik, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Svetlana Pundik, MD Louis Stokes VA Medical Center, Cleveland, OH
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03666533    
Other Study ID Numbers: N2620-R
15036-H19 ( Other Grant/Funding Number: Louis Stokes Cleveland VA Medical Center IRB )
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)

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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
Keywords provided by VA Office of Research and Development:
Gait therapy
transcranial Direct Current Stimulation (tDCS)
Neuroplasticity
walking ability
brain stimulation
virtual reality
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases