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Completed

NCT Number: NCT03886857

Segmental Mechanisms of Transcutaneous Spinal Cord Stimulation for Spasticity Control

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik Floridsdorf, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transcutaneous Spinal Cord Stimulation

Device

noninvasive electrical stimulation of the human lumbar spinal cord

Primary outcomes

  1. Postsynaptic inhibition

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

    reciprocal inhibition of the soleus H-reflex

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Peter Lackner

Other

Collaborators

  • Medical University of Vienna

Registry information

Official study title

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

Acronym: SCS_CorE_AT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2019
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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