Segmental Mechanisms of Transcutaneous Spinal Cord Stimulation for Spasticity Control

Not Applicable

Completed

• Conditions: Spinal Cord Injuries

• Registration Number: NCT03886857
• Lead Sponsor: Peter Lackner

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-22
• Study Start: 2019-05-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Postsynaptic inhibition	pre-intervention to 2 hours post-intervention	reciprocal inhibition of the soleus H-reflex

Secondary Outcome Measures

Name	Time	Method
Presynaptic inhibition	pre-intervention to 2 hours post-intervention	induced D1 inhibition and ongoing presynaptic inhibition of the soleus-H reflex
H_max/M_max	pre-intervention to 2 hours post-intervention	Ratio of the maximum H reflex and the maximum M wave
Low-frequency depression	pre-intervention to 2 hours post-intervention	rate-dependent depression of the soleus H-reflex
Evaluation of lower-limb spasticity	pre-intervention to 2 hours post-intervention	surface-electromyography based assessments

Trial Locations

Locations (2)

Medical University of Vienna; 🇦🇹 Vienna, Austria

Klinik Floridsdorf; 🇦🇹 Vienna, Austria