Motor Control in Incomplete Spinal Cord Injured PersonsNCT03137108
Effects of Transcutaneous Spinal Cord Stimulation on Residual Voluntary Motor Control in Individuals With Incomplete Spinal Cord Injury
A study testing Transcutaneous electrical spinal cord stimulation in people with Motor Control in Incomplete Spinal Cord Injured Persons, run by University of Zurich at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Motor Control in Incomplete Spinal Cord Injured Persons
- What is being tested?
- Transcutaneous electrical spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2017to 12 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Transcutaneous electrical spinal cord stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical spinal cord stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Incomplete Spinal cord injury | Experimental | Not described Receives: Device: Transcutaneous electrical spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic movement characteristics recorded with a motion capture system;
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start1 Oct 2017
- Primary completion12 Nov 2019
- Study completion12 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Control in Incomplete Spinal Cord Injured PersonsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137108
- Sponsor's protocol ID
- 2017-00053
- Other IDs
- 2017
- Status last verified
- Oct 2022
- First submitted
- 21 Apr 2017
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03137108
- Acronym / sponsor ID
- 2017-00053
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Incomplete Spinal cord injury | Experimental | Device: Transcutaneous electrical spinal cord stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical spinal cord stimulationStudy 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. | Device | Incomplete Spinal cord injury |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical spinal cord stimulation in people with Motor Control in Incomplete Spinal Cord Injured Persons, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.