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

NCT03815721 | Terminated

• 1 other identifier: 2016-16
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Spasticity, Muscle

Outcome Measures

Primary Outcomes (1)

• Change in spasticity index

  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.

  from day 1 to day 57

Secondary Outcomes (7)

• Change in numeric rating scale spasticity

  day 1, 8, 29, 50 and 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 Penn Spasm Frequency Scale

  from day 1 to day 57

• Change in resistance of the lower limbs

  from day 1 to day 57

Study Arms (2)

daily stimulation

EXPERIMENTAL

30-minute sessions of transcutaneous spinal cord stimulation using the Stimulette r2x+ will be repetitively applied 7 times per week.

Device: Stimulette r2x+

stimulation every other day

EXPERIMENTAL

30-minute sessions of transcutaneous spinal cord stimulation using the Stimulette r2x+ will be repetitively applied 3 times per week.

Device: Stimulette r2x+

Interventions

Stimulette r2x+ DEVICE

device for repetitive transcutaneous spinal cord stimulation

daily stimulation; stimulation every other day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead
• Medical University of Vienna: collaborator

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Muscle Spasticity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ursula Hofstötter

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

• Angela Frotzler

  Swiss Paraplegic Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Medical Sciences

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 24, 2019
• Study Start: January 7, 2019
• Primary Completion: May 10, 2021
• Study Completion: May 10, 2021
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)