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

Primary Purpose

Motor Control in Incomplete Spinal Cord Injured Persons

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Transcutaneous electrical spinal cord stimulation

About this trial

This is an interventional treatment trial for Motor Control in Incomplete Spinal Cord Injured Persons

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Universitätsklinik Balgrist

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Incomplete Spinal cord injury

Arm Description

Outcomes

Primary Outcome Measures

Kinematic movement characteristics recorded with a motion capture system;

Secondary Outcome Measures

Full Information

NCT ID

NCT03137108

First Posted

April 21, 2017

Last Updated

October 3, 2022

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT03137108

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

October 1, 2017 (Actual)

Primary Completion Date

November 12, 2019 (Actual)

Study Completion Date

November 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Motor Control in Incomplete Spinal Cord Injured Persons

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Incomplete Spinal cord injury

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Transcutaneous electrical spinal cord stimulation

Intervention Description

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 Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Universitätsklinik Balgrist

City

Zürich

Country

Switzerland

12. IPD Sharing Statement

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

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