Segmental Mechanisms of Transcutaneous Spinal Cord Stimulation for Spasticity Control

Spinal Cord Injuries Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03886857
• Other study ID #: SCS-CorE_AT
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: May 2023
• Source: Otto Wagner Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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

Locations

Country	Name	City	State
Austria	Klinik Floridsdorf	Vienna
Austria	Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Peter Lackner	Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postsynaptic inhibition	reciprocal inhibition of the soleus H-reflex	pre-intervention to 2 hours post-intervention
Secondary	Presynaptic inhibition	induced D1 inhibition and ongoing presynaptic inhibition of the soleus-H reflex	pre-intervention to 2 hours post-intervention
Secondary	H_max/M_max	Ratio of the maximum H reflex and the maximum M wave	pre-intervention to 2 hours post-intervention
Secondary	Low-frequency depression	rate-dependent depression of the soleus H-reflex	pre-intervention to 2 hours post-intervention
Secondary	Evaluation of lower-limb spasticity	surface-electromyography based assessments	pre-intervention to 2 hours post-intervention