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Clinical Trials/NCT03815721
NCT03815721
Terminated
Not Applicable

Carry-over Effects of Repetitively Applied Transcutaneous Spinal Cord Stimulation on Spasticity and Residual Motor Control in Incomplete Spinal Cord Injured Individuals

Swiss Paraplegic Research, Nottwil1 site in 1 country12 target enrollmentJanuary 7, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
Swiss Paraplegic Research, Nottwil
Enrollment
12
Locations
1
Primary Endpoint
Change in spasticity index
Status
Terminated
Last Updated
5 months ago

Overview

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 sequelae. Its various clinical manifestations include spasms, clonus, and resistance to passive movements, and often present a major hindrance in rehabilitation, further deteriorate residual motor performance, and negatively impact independence and quality of life. Despite its high prevalence, successful management of spasticity has remained difficult. Standard-of-care treatment modalities are often insufficient or bear the risk of undesirable side effects further accentuating paresis. Epidural stimulation of the lumbar spinal cord via implanted electrodes provides for an alternative approach. It works through modifying the dysregulated neural signal processing of spared spinal circuitry caudal to the injury. Its ameliorative effects on severe lower-limb spasticity have been repetitively reported. Yet, epidural spinal cord stimulation in motor disorders is still off-label, applied in relatively few patients only, also because of its invasive character, the time consuming testing phase for its effective application, and the lack of markers to identify responders in advance. With the development of transcutaneous spinal cord stimulation, a method became available to activate the same input structures to the lumbar spinal cord as with epidural stimulation and hence to induce similar neuromodulatory effects, yet non-invasively, using standard equipment available at rehabilitation centers. A recent proof-of-concept study has shown that a single 30-minute session of transcutaneous spinal cord stimulation controlled various clinical signs of spasticity and augmented residual motor control in spinal cord injured individuals for several hours beyond its application. Further, in one subject, the stimulation was repetitively applied for six weeks, resulting in cumulative therapeutic effects persisting for 10 days after its discontinuation. These observations strongly suggest that the stimulation can induce beneficial neuroplastic adaptations of spared spinal systems and their interaction with residual supraspinal control. The proposed research aims at studying the reproducibility of these findings in a statistically sound cohort of individuals with spinal cord injury and testing the applicability and acceptance of transcutaneous spinal cord stimulation as a home-based therapy.

Registry
clinicaltrials.gov
Start Date
January 7, 2019
End Date
May 10, 2021
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Swiss Paraplegic Research, Nottwil
Responsible Party
Principal Investigator
Principal Investigator

Bersch-Porada Ines

PhD in Medical Sciences

Swiss Paraplegic Research, Nottwil

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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)

Outcomes

Primary Outcomes

Change in spasticity index

Time Frame: from day 1 to day 57

Spasticity index based on the Wartenberg pendulum test: For the pendulum test, subjects will be in a supported sitting position with the trunk reclined approximately 30°. The examiner will lift one leg to a horizontal position, release it, and let it oscillate passively until it stops. The pendulum test will be repeated three times on each side, separated by phases of relaxation. The spasticity index is calculated subtracting the knee angle of the initial horizontal leg position from the peak flexion angle of the first swing divided by the final knee resting angle. Scores ≥ 1 denote non-spastic conditions, and 0 extreme spasticity.

Secondary Outcomes

  • Change in numeric rating scale spasticity(day 1, 8, 29, 50 and 57)
  • Change in 6-minute walk test(from day 1 to day 57)
  • Change in Penn Spasm Frequency Scale(from day 1 to day 57)
  • Change in Modified Ashworth Scale(from day 1 to day 57)
  • Change in adductor tone rating(from day 1 to day 57)
  • Change in resistance of the lower limbs(from day 1 to day 57)
  • Change in Walking Index for Spinal Cord Injury II Scale(from day 1 to day 57)

Study Sites (1)

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