Spinal Cord Injuries
Conditions
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.
Interventions
DEVICEtranscutaneous spinal cord stimulation
noninvasive electrical stimulation of the human lumbar spinal cord
Sponsors
Medical University of Vienna
Peter Lackner
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postsynaptic inhibition | pre-intervention to 2 hours post-intervention | reciprocal inhibition of the soleus H-reflex |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presynaptic inhibition | pre-intervention to 2 hours post-intervention | induced D1 inhibition and ongoing presynaptic inhibition of the soleus-H reflex |
| H_max/M_max | pre-intervention to 2 hours post-intervention | Ratio of the maximum H reflex and the maximum M wave |
| Low-frequency depression | pre-intervention to 2 hours post-intervention | rate-dependent depression of the soleus H-reflex |
| Evaluation of lower-limb spasticity | pre-intervention to 2 hours post-intervention | surface-electromyography based assessments |
Countries
Austria
Outcome results
None listed