Effects of Transcutaneous Spinal Cord Stimulation on Residual Voluntary Motor Control in Individuals With Incomplete Spinal Cord Injury

University of Zurich (UZH)

Status: Completed

Conditions: Motor Control in Incomplete Spinal Cord Injured Persons

Treatments: Device: Transcutaneous electrical spinal cord stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03137108

2017-00053

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Incomplete Spinal cord injury

Experimental group

Treatment:

Device: Transcutaneous electrical spinal cord stimulation