Completed

NCT Number: NCT03137108

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

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.

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Key information

Conditions

Motor Control in Incomplete Spinal Cord Injured Persons

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinik Balgrist

Zurich, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study 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

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: May 2, 2017
Registry last updated: Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.