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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
transcutaneous spinal cord stimulation
Sponsored by
Peter Lackner
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Medical University of Vienna
  • Klinik Floridsdorf

Outcomes

Primary Outcome Measures

Postsynaptic inhibition
reciprocal inhibition of the soleus H-reflex

Secondary Outcome Measures

Presynaptic inhibition
induced D1 inhibition and ongoing presynaptic inhibition of the soleus-H reflex
H_max/M_max
Ratio of the maximum H reflex and the maximum M wave
Low-frequency depression
rate-dependent depression of the soleus H-reflex
Evaluation of lower-limb spasticity
surface-electromyography based assessments

Full Information

First Posted
March 18, 2019
Last Updated
May 30, 2023
Sponsor
Peter Lackner
Collaborators
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT03886857
Brief Title
Segmental Mechanisms of Transcutaneous Spinal Cord Stimulation for Spasticity Control
Acronym
SCS_CorE_AT
Official Title
Carry-over Effects of Transcutaneous Spinal Cord Stimulation for Spasticity Control on Inhibitory Circuits of the Spinal Cord: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Lackner
Collaborators
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
transcutaneous spinal cord stimulation
Intervention Description
noninvasive electrical stimulation of the human lumbar spinal cord
Primary Outcome Measure Information:
Title
Postsynaptic inhibition
Description
reciprocal inhibition of the soleus H-reflex
Time Frame
pre-intervention to 2 hours post-intervention
Secondary Outcome Measure Information:
Title
Presynaptic inhibition
Description
induced D1 inhibition and ongoing presynaptic inhibition of the soleus-H reflex
Time Frame
pre-intervention to 2 hours post-intervention
Title
H_max/M_max
Description
Ratio of the maximum H reflex and the maximum M wave
Time Frame
pre-intervention to 2 hours post-intervention
Title
Low-frequency depression
Description
rate-dependent depression of the soleus H-reflex
Time Frame
pre-intervention to 2 hours post-intervention
Title
Evaluation of lower-limb spasticity
Description
surface-electromyography based assessments
Time Frame
pre-intervention to 2 hours post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Hofstoetter, Prof., PhD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Klinik Floridsdorf
City
Vienna
ZIP/Postal Code
1210
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

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Segmental Mechanisms of Transcutaneous Spinal Cord Stimulation for Spasticity Control

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