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

NCT03137108 | Completed

• 1 other identifier: 2017-00053
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Kinematic movement characteristics recorded with a motion capture system;

  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.

Study Arms (1)

Incomplete Spinal cord injury

EXPERIMENTAL

Device: Transcutaneous electrical spinal cord stimulation

Interventions

Transcutaneous electrical spinal cord stimulation 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.

Incomplete Spinal cord injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Universitätsklinik Balgrist

Zurich, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: May 2, 2017
• Study Start: October 1, 2017
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: October 4, 2022

Record last verified: 2022-10

Locations

CH (1)