Segmental Mechanisms of Transcutaneous Spinal Cord Stimulation for Spasticity Control

NCT03886857 | Completed

• 1 other identifier: SCS-CorE_AT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Postsynaptic inhibition

  reciprocal inhibition of the soleus H-reflex

  pre-intervention to 2 hours post-intervention

Secondary Outcomes (4)

• 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

Interventions

transcutaneous spinal cord stimulation DEVICE

noninvasive electrical stimulation of the human lumbar spinal cord

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peter Lackner: lead
• Medical University of Vienna: collaborator

Study Sites (2)

Medical University of Vienna

Vienna, 1090, Austria

Location

Klinik Floridsdorf

Vienna, 1210, Austria

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ursula Hofstoetter, Prof., PhD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 22, 2019
• Study Start: May 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)