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

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ClinicalTrials.gov Identifier: NCT03886857
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by (Responsible Party):
Peter Lackner, Otto Wagner Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: transcutaneous spinal cord stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Carry-over Effects of Transcutaneous Spinal Cord Stimulation for Spasticity Control on Inhibitory Circuits of the Spinal Cord: a Pilot Study
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022
Arms and Interventions
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Intervention Details:
  • Device: transcutaneous spinal cord stimulation
    noninvasive electrical stimulation of the human lumbar spinal cord

Outcome Measures
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Primary Outcome Measures :
  1. H_max/M_max [ Time Frame: 2 hours post-intervention ]
    Ratio of the maximum H reflex and the maximum M wave


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886857


Contacts
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Contact: Ursula Hofstoetter, PhD +43 1 40400 ext 19720 ursula.hofstoetter@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna Active, not recruiting
Vienna, Austria, 1090
Otto Wagner Hospital Recruiting
Vienna, Austria, 1140
Contact: Peter Lackner, Prof., MD    +43 91060 ext 20708    peter.lackner@wienkav.at   
Sponsors and Collaborators
Peter Lackner
Medical University of Vienna
Investigators
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Principal Investigator: Ursula Hofstoetter, PhD Medical University of Vienna
More Information
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Responsible Party: Peter Lackner, Chief Physician, Otto Wagner Hospital
ClinicalTrials.gov Identifier: NCT03886857    
Other Study ID Numbers: SCS-CorE_AT
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries