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

NCT ID: NCT03815721

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2021-05-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

daily stimulation

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

Group Type: EXPERIMENTAL

Stimulette r2x+

Intervention Type: DEVICE

device for repetitive transcutaneous spinal cord stimulation

stimulation every other day

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

Group Type: EXPERIMENTAL

Stimulette r2x+

Intervention Type: DEVICE

device for repetitive transcutaneous spinal cord stimulation

Interventions

Stimulette r2x+

device for repetitive transcutaneous spinal cord stimulation

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role: lead

Medical University of Vienna

OTHER

Sponsor Role: collaborator

Responsible Party

Bersch-Porada Ines

PhD in Medical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ursula Hofstötter

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna

Angela Frotzler

Role: PRINCIPAL_INVESTIGATOR

Swiss Paraplegic Centre

Locations

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland

Countries

Switzerland

Other Identifiers

2016-16

Identifier Type: -

Identifier Source: org_study_id