Segmental Mechanisms of Transcutaneous Spinal Cord Stimulation for Spasticity Control

NCT ID: NCT03886857

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2022-10-01

Brief Summary

The aim of the pilot study is to gain first insights into the interaction of transcutaneous spinal cord stimulation with the altered activity of intraspinal circuits associated with spinal spasticity. The main goal is to evaluate the validity of the chosen measures and to generate a data base for statistical planning of a subsequent clinical study.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

transcutaneous spinal cord stimulation

noninvasive electrical stimulation of the human lumbar spinal cord

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

written informed consent prior to participation

for participants with intact CNS:

• no previous neurological or musculoskeletal disorders

for participants with spinal cord injury:

• Spinal cord injury due to trauma
• ≥ 12 months post-spinal cord injury
• complete or incomplete spinal cord injury classified as grade C or D on the American Spinal Injury Association Impairment Scale (AIS)
• neurological level of spinal cord injury: C3-T10
• preserved tendon and cutaneo-muscular reflexes in the lower limbs

Exclusion Criteria

• other neuromuscular diseases, e.g., amyotrophic lateral sclerosis (ALS), Parkinson's disease, Guillain-Barré syndrome, muscular dystrophy
• active implants (e.g., cardiac pacemaker, drug pump)
• passive implants at vertebral level T10 or caudal (e.g., metal screws/plates for surgical stabilization of spinal fractures)
• active infections or diseases, pressure sores
• dermatological issues at the stimulation site
• malignant diseases
• heart insufficiency (NYHA III-IV)
• potential pregnancy (pregnancy test to be conducted in women of child bearing age before application of transcutaneous spinal cord stimulation)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: collaborator

Peter Lackner

OTHER

Sponsor Role: lead

Responsible Party

Peter Lackner

Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ursula Hofstoetter, Prof., PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Klinik Floridsdorf

Vienna, , Austria

Countries

Austria

Other Identifiers

SCS-CorE_AT

Identifier Type: -

Identifier Source: org_study_id