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

October 3, 2022 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland
        • Universitätsklinik Balgrist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

November 12, 2019

Study Completion (Actual)

November 12, 2019

Study Registration Dates

First Submitted

April 21, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-00053

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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