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Trial record 50 of 283 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury (TSCS)

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ClinicalTrials.gov Identifier: NCT03384017
Recruitment Status : Recruiting
First Posted : December 27, 2017
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Aim 1: Determine the neurophysiologic impact of Transcutaneous Spinal Cord Stimulation (TSCS) within a single session. The investigators hypothesize that subjects will demonstrate increased volitional muscle activity and strength with TSCS. This will be assessed by surface EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum volitional contraction (MVC) and measurement of gait speed. Subjects will be tested in both TSCS and sham conditions.

Aim 2: Determine the impact of TSCS and gait training on walking function. The investigators hypothesize that concurrent TSCS and gait training will augment walking function in subjects with iSCI, as compared to gait training alone. Subjects will participate in an eight-week program of gait training with TSCS and be assessed with clinically relevant outcome measures, to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II, and 6-Minute Walk Test.


Condition or disease Intervention/treatment
Spinal Cord Injuries Other: Transcutaneous Spinal Cord Stimulation and Gait Training

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking Description: All assessors will be blind to intervention
Primary Purpose: Treatment
Official Title: The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury
Actual Study Start Date : January 5, 2017
Estimated Primary Completion Date : January 5, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: TSCS and gait training Other: Transcutaneous Spinal Cord Stimulation and Gait Training

TSCS will be applied using a midline electrode placed on the skin between spinous process T11 -T12 and two electrodes placed symmetrically on the skin over the lower abdomen as anodes. A symmetrical biphasic rectangular waveform, at 50 Hz and 1 millisecond, is used to provide 30 continuous minutes of stimulation.

Subjects will participate in 24 two-hour sessions of physical therapy over eight weeks. In each session, subjects will receive TSCS continuously for 30 minutes, using the parameters outlined above. During stimulation, subjects will participate in strengthening, segmental task practice, and gait-based interventions. Participation in gait training will continue following the stimulation period for the duration of the session.



Outcome Measures

Primary Outcome Measures :
  1. Change in walking speed [ Time Frame: At the beginning, midpoint, and end of study (study is 8 weeks) ]
    10-Meter Walk Test


Secondary Outcome Measures :
  1. Change in walking capacity [ Time Frame: At the beginning, midpoint, and end of study (study is 8 weeks) ]
    Timed Up and Go

  2. Change in level of assistance and assistive device for walking [ Time Frame: At the beginning, midpoint, and end of study (study is 8 weeks) ]
    Walking Index for Spinal Cord Injury II

  3. Change in walking endurance [ Time Frame: At the beginning, midpoint, and end of study (study is 8 weeks) ]
    6-Minute Walk Test


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-65 years old
  • >1 year post SCI
  • Non-progressive SCI
  • Neurological level above T10
  • Tolerates upright position for >30 minutes
  • Medically stable (no hospitalizations in last 3 months)
  • Able to comply with procedures and follow up
  • Are legally able to make their own health care decisions

Exclusion Criteria:

  • Progressive SCI/D (MS, ALS, ADEM, etc.)
  • Open wounds at stimulation site
  • Pregnant women
  • ROM limitations impacting gait training
  • Cardiac pacemaker/defibrillator
  • Active cancer diagnosis
  • Currently receiving TSCS
  • Evidence of uncontrolled autonomic dysreflexia
  • Non-English speaking subjects will not be targeted
Contacts and Locations

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): NCT03384017


Contacts
Contact: Shannon M Inches 443-923-9235 inches@kennedykrieger.org
Contact: Rebecca Martin, OTR/L, OTD, CPAM 443-923-7972 MartinRe@kennedykrieger.org

Locations
United States, Maryland
Rebecca Martin, OTR/L, OTD, CPAM Recruiting
Baltimore, Maryland, United States, 21205
Contact: Shannon M Inches    443-923-9235    inches@kennedykrieger.org   
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
More Information

Responsible Party: Rebecca Martin, OTR/L, OTD, Manager Clinical Education and Training, International Center for Spinal Cord Injury Assistant Professor, Johns Hopkins School of Medicine, Dept. of Physical Medicine and Rehabilitation, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT03384017     History of Changes
Other Study ID Numbers: IRB00053916
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System