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

Carry-over Effects of Transcutaneous Spinal Cord Stimulation for Spasticity Control on Inhibitory Circuits of the Spinal Cord: a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: transcutaneous spinal cord stimulation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ursula Hofstoetter, PhD; Phone Number: 19720 +43 1 40400; Email: ursula.hofstoetter@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna
  • Vienna, Austria, 1210
    • Klinik Floridsdorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postsynaptic inhibition	reciprocal inhibition of the soleus H-reflex	pre-intervention to 2 hours post-intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peter Lackner
• Collaborators: Medical University of Vienna
• Investigators: Principal Investigator: Ursula Hofstoetter, Prof., PhD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: SCS-CorE_AT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No