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

Peter Lackner2 sites in 1 country30 target enrollmentMay 1, 2019

ConditionsSpinal Cord Injuries

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spinal Cord Injuries
Sponsor: Peter Lackner
Enrollment: 30
Locations: 2
Primary Endpoint: Postsynaptic inhibition
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 1, 2019

End Date

October 1, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peter Lackner

Responsible Party

Sponsor Investigator

Principal Investigator

Peter Lackner

Chief Physician

Klinikum Floridsdorf

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)

Outcomes

Primary Outcomes

Postsynaptic inhibition

Time Frame: pre-intervention to 2 hours post-intervention

reciprocal inhibition of the soleus H-reflex

Secondary Outcomes

Presynaptic inhibition(pre-intervention to 2 hours post-intervention)
H_max/M_max(pre-intervention to 2 hours post-intervention)
Low-frequency depression(pre-intervention to 2 hours post-intervention)
Evaluation of lower-limb spasticity(pre-intervention to 2 hours post-intervention)