Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03886857
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : June 1, 2023
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by (Responsible Party):
Peter Lackner, Otto Wagner Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
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
Actual Primary Completion Date : October 1, 2022
Actual Study Completion Date : October 1, 2022
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: transcutaneous spinal cord stimulation
    noninvasive electrical stimulation of the human lumbar spinal cord

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Postsynaptic inhibition [ Time Frame: pre-intervention to 2 hours post-intervention ]
    reciprocal inhibition of the soleus H-reflex


Secondary Outcome Measures :
  1. Presynaptic inhibition [ Time Frame: pre-intervention to 2 hours post-intervention ]
    induced D1 inhibition and ongoing presynaptic inhibition of the soleus-H reflex

  2. H_max/M_max [ Time Frame: pre-intervention to 2 hours post-intervention ]
    Ratio of the maximum H reflex and the maximum M wave

  3. Low-frequency depression [ Time Frame: pre-intervention to 2 hours post-intervention ]
    rate-dependent depression of the soleus H-reflex

  4. Evaluation of lower-limb spasticity [ Time Frame: pre-intervention to 2 hours post-intervention ]
    surface-electromyography based assessments


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Layout table for location information
Austria
Medical University of Vienna
Vienna, Austria, 1090
Klinik Floridsdorf
Vienna, Austria, 1210
Sponsors and Collaborators
Peter Lackner
Medical University of Vienna
Investigators
Layout table for investigator information
Principal Investigator: Ursula Hofstoetter, Prof., PhD Medical University of Vienna
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: June 1, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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