Clinical trial NCT03137108: Effects of Transcutaneous Spinal Cord Stimulation on Residual Voluntary Motor Control in Individuals With Incomplete Spinal Cord Injury
Official title: Effects of Transcutaneous Spinal Cord Stimulation on Residual Voluntary Motor Control, Standing, and Overground Walking in Individuals With Incomplete Spinal Cord Injury Single Centre Pilot Study Investigating Immediate Effects of Transcutaneous Electrical Spinal Cord Stimulation on Voluntary Ankle and Knee Control, Standing and Overground Walking in Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Control in Incomplete Spinal Cord Injured Persons
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Recently, a transcutaneous protocol of electrical spinal cord stimulation (tSCS) has been developed. It was suggested, that this method could be used to improve the therapy process after a spinal cord injury (SCI). The aim of this study is to investigate the immediate effects of tSCS with different stimulation modalities on voluntary motor control in patients with incomplete SCI.


Eligibility criteria: Inclusion Criteria:

* Patients with incomplete SCI
* Chronic (≥ 12 months post-injury) or subacute (≥ 3 months post-injury) stage of recovery
* Age: ≥18 years
* Able to complete the 10mWT with walking aids as required but no physical assistance
* Neurological level of SCI: above T12
* Preserved segmental and cutaneo-muscular reflexes in the lower limbs
* Bodyweight \> 20 kg and \< 120 kg
* Mini-Mental state examination score 6 (test only performed if cognitive deficits are suspected)

Exclusion Criteria:

* Any other neurological diseases
* Current orthopedic problems
* Premorbid major depression or psychosis
* History of significant autonomic dysreflexia with treatment
* Dermatological issues (e.g. decubitus) at the stimulation or harness attachment site (back, abdomen, upper legs)
* Active implants (e.g. cardiac pacemaker, implanted drug pump)
* Passive implants at vertebral level T9 or more caudal vertebrae (metal screws and plates for surgical stabilization of spinal fractures)
* Malignant diseases
* Heart insufficiency NYHA III-IV
* Potential pregnancy (pregnancy test must be conducted before each session)
* Unlikely to complete the intervention or return for follow-up
* Participation in another training study
* Contraindications for BWS training using the FLOAT (according the manual):
* No responsiveness
* Severe muscle contractures
* Acute fractures
* Osteoporosis or osteogenesis imperfecta
* Body size shorter than 1 meter or taller than 2 meters

Primary outcomes:
measure: Kinematic movement characteristics recorded with a motion capture system;
timeFrame: Baseline and intervention of a specific task will be assessed directly after each other in a single session. All movement tasks will be split into 2 sessions within 2 weeks. The start of the first session is variable.
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Universitätsklinik Balgrist
Study officials:
References: