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Effects of Transcutaneous Spinal Cord Stimulation on Residual Voluntary Motor Control in Individuals With Incomplete Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03137108
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
Recently, a transcutaneous protocol of electrical spinal cord stimulation (tSCS) has been developed. It was suggested, that this method could be used to improve the therapy process after a spinal cord injury (SCI). The aim of this study is to investigate the immediate effects of tSCS with different stimulation modalities on voluntary motor control in patients with incomplete SCI.

Condition or disease Intervention/treatment Phase
Motor Control in Incomplete Spinal Cord Injured Persons Device: Transcutaneous electrical spinal cord stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Transcutaneous Spinal Cord Stimulation on Residual Voluntary Motor Control, Standing, and Overground Walking in Individuals With Incomplete Spinal Cord Injury Single Centre Pilot Study Investigating Immediate Effects of Transcutaneous Electrical Spinal Cord Stimulation on Voluntary Ankle and Knee Control, Standing and Overground Walking in Incomplete Spinal Cord Injury
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Incomplete Spinal cord injury Device: Transcutaneous electrical spinal cord stimulation
Study intervention consists of the application of tSCS at three different frequencies (15 Hz, 30 Hz, 50 Hz) using the CE certified electrostimulator RehaMove 3. Stimulation will only be applied by an investigator during the two testing sessions. During the overground walking, the participants will be secured and assisted with the cable-driven body-weight support system FLOAT.




Primary Outcome Measures :
  1. Kinematic movement characteristics recorded with a motion capture system; [ Time Frame: Baseline and intervention of a specific task will be assessed directly after each other in a single session. All movement tasks will be split into 2 sessions within 2 weeks. The start of the first session is variable. ]
  2. Kinetic movement characteristics recorded with force plates [ Time Frame: Baseline and intervention of a specific task will be assessed directly after each other in a single session. All movement tasks will be split into 2 sessions within 2 weeks. The start of the first session is variable. ]


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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:

  • Patients with incomplete SCI
  • Chronic (≥ 12 months post-injury) or subacute (≥ 3 months post-injury) stage of recovery
  • Age: ≥18 years
  • Able to complete the 10mWT with walking aids as required but no physical assistance
  • Neurological level of SCI: above T12
  • Preserved segmental and cutaneo-muscular reflexes in the lower limbs
  • Bodyweight > 20 kg and < 120 kg
  • Mini-Mental state examination score 6 (test only performed if cognitive deficits are suspected)

Exclusion Criteria:

  • Any other neurological diseases
  • Current orthopedic problems
  • Premorbid major depression or psychosis
  • History of significant autonomic dysreflexia with treatment
  • Dermatological issues (e.g. decubitus) at the stimulation or harness attachment site (back, abdomen, upper legs)
  • Active implants (e.g. cardiac pacemaker, implanted drug pump)
  • Passive implants at vertebral level T9 or more caudal vertebrae (metal screws and plates for surgical stabilization of spinal fractures)
  • Malignant diseases
  • Heart insufficiency NYHA III-IV
  • Potential pregnancy (pregnancy test must be conducted before each session)
  • Unlikely to complete the intervention or return for follow-up
  • Participation in another training study
  • Contraindications for BWS training using the FLOAT (according the manual):
  • No responsiveness
  • Severe muscle contractures
  • Acute fractures
  • Osteoporosis or osteogenesis imperfecta
  • Body size shorter than 1 meter or taller than 2 meters

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): NCT03137108


Contacts
Contact: Christian Meyer +41 44 510 72 17 christian.meyer@balgrist.ch

Locations
Switzerland
Universitätsklinik Balgrist Recruiting
Zürich, Switzerland
Contact: Armin Curt    +41 44 386 39 01    armin.curt@balgrist.ch   
Sponsors and Collaborators
University of Zurich

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03137108     History of Changes
Other Study ID Numbers: 2017-0053
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

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

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