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

University of Zurich1 site in 1 country10 target enrollmentOctober 1, 2017

ConditionsMotor Control in Incomplete Spinal Cord Injured Persons

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Motor Control in Incomplete Spinal Cord Injured Persons
Sponsor: University of Zurich
Enrollment: 10
Locations: 1
Primary Endpoint: Kinematic movement characteristics recorded with a motion capture system;
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2017

End Date

November 12, 2019

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Zurich

Responsible Party

Sponsor

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)

Outcomes

Primary Outcomes

Kinematic movement characteristics recorded with a motion capture system;

Time Frame: 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.