Status:

TERMINATED

Carry-over Effects of Repetitively Applied Transcutaneous Spinal Cord Stimulation on Spasticity

Lead Sponsor:

Swiss Paraplegic Research, Nottwil

Collaborating Sponsors:

Medical University of Vienna

Conditions:

Spinal Cord Injuries

Spasticity, Muscle

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Spinal cord injury is a devastating condition, causing substantial impairment of vital body functions caudal to the lesion. A major cause of disability stems from spasticity, a common secondary sequel...

Eligibility Criteria

Inclusion

  • motor and sensory incomplete spinal cord injury classified as grade C or D on the American Spinal Injury Association Impairment Scale
  • neurological level of spinal cord injury: third cervical to tenth thoracic segment
  • chronic condition (≥ 12 months post-spinal cord injury)
  • preserved segmental and cutaneo-muscular reflexes in the lower limbs
  • able to be verticalized for 6 minutes (with walking aids)
  • preserved joint mobility, no musculoskeletal diseases
  • spasticity (with/without antispasticity medication)
  • stable antispasmodic medication one month prior to as well as during study participation

Exclusion

  • neuromuscular diseases, e.g., amyotrophic lateral sclerosis (ALS), Parkinson's disease, Guillain-Barré syndrome, muscular dystrophy
  • dermatological issues at the stimulation site
  • acute urinary tract infection at study entry
  • active implants (e.g., cardiac pacemaker, drug pump)
  • passive implants between the ninth thoracic level and the first lumbal level (e.g. metal screws/plates for surgical stabilization of spinal fractures)
  • malignant diseases
  • heart insufficiency
  • potential pregnancy (pregnancy test to be conducted as part of the first evaluation)

Key Trial Info

Start Date :

January 7 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 10 2021

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT03815721

Start Date

January 7 2019

End Date

May 10 2021

Last Update

November 26 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland, 6207

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