Segmental Mechanisms of Transcutaneous Spinal Cord Stimulation for Spasticity Control (SCS_CorE_AT)

Peter Lackner

Status

Completed

Conditions

Spinal Cord Injuries

Treatments

Device: transcutaneous spinal cord stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03886857

SCS-CorE_AT

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)