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

NCT ID: NCT03137108

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-11-12

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.

Conditions

Motor Control in Incomplete Spinal Cord Injured Persons

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Incomplete Spinal cord injury

Group Type: EXPERIMENTAL

Transcutaneous electrical spinal cord stimulation

Intervention Type: DEVICE

Study intervention consists of the application of tSCS at three different frequencies (15 Hz, 30 Hz, 50 Hz) using the CE certified electrostimulator RehaMove 3. Stimulation will only be applied by an investigator during the two testing sessions. During the overground walking, the participants will be secured and assisted with the cable-driven body-weight support system FLOAT.

Interventions

Transcutaneous electrical spinal cord stimulation

Study intervention consists of the application of tSCS at three different frequencies (15 Hz, 30 Hz, 50 Hz) using the CE certified electrostimulator RehaMove 3. Stimulation will only be applied by an investigator during the two testing sessions. During the overground walking, the participants will be secured and assisted with the cable-driven body-weight support system FLOAT.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinik Balgrist

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2017-00053

Identifier Type: -

Identifier Source: org_study_id