Spinal Cord InjuriesNCT04977284
Noninvasive Neuroprosthesis for Autonomic Recovery After SCI
A study testing DS7R, Digitimer, UK in people with Spinal Cord Injuries, run by University of British Columbia.
Trial summary
This research study is being conducted to help explore the effects of non-invasive (non-surgical) spinal cord stimulation via sticky electrodes over the skin (transcutaneous spinal cord stimulation; TCSCS) on bowel, bladder and sexual function following spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- DS7R, Digitimer, UK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 30 Apr 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resident of British Columbia, Canada with active provincial medical services plan
- Male or female, 18-65 years of age
- Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T10 spinal segment.
- >1-year post injury, at least 6 months from any spinal surgery.
- American Spinal Injury Association Impairment Scale (AIS) A, B.
- Willing and able to comply with all clinic visits and study-related procedures.
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- Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
- No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing activities.
- Stable management of spinal cord related clinical issues (i.e., spasticity management).
- Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
- Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit. During the trial, all women of childbearing potential will undergo urine pregnancy tests at their monthly clinic visits as outlined in the schedule of events.
- Women of childbearing potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.
- Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.
- Must provide informed consent.
Who cannot join
- Presence of severe acute medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to clinically significant renal or hepatic disease; acute urinary tract infections; pressure sores; active heterotopic ossification; newly changed antidepressant medications [tricyclics]; or unstable diabetes.
- Recent treatment with OnabotulinumtoxinA into the detrusor muscle (relative contraindication).
- Ventilator dependent
- Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study.
- Intrathecal baclofen pump.
- Cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
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- Any implanted metal in trunk or spinal cord under the sites of application of electrodes (between anode and cathode).
- Participant is a member of the investigational team or his /her immediate family.
- Participant has undergone electrode implantation surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Noninvasive Neuroprosthesis for Autonomic Recovery After Spinal Cord Injury
This research study is being conducted to help explore the effects of non-invasive (non-surgical) spinal cord stimulation via sticky electrodes over the skin (transcutaneous spinal cord stimulation; TCSCS) on bowel, bladder and sexual function following spinal cord injury. Our primary aim is to determine the specific location and timing of TCSCS at various spinal cord levels in order to target bladder and bowel control (Study 1 and 2), and to assess the safety and effectiveness of TCSCS during bladder and bowel function assessments (Study 2 only). Participants may choose to participate in either Study 1 or 2.
- Conditions
- Spinal Cord Injuries
- Being tested
- DS7R, Digitimer, UK
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS7R, Digitimer, UKDevice
Non-surgical spinal cord stimulation will be applied and electrical activity of muscles will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| TCSCS | Experimental | Not described Receives: Device: DS7R, Digitimer, UK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation of spinal circuits
Activation of spinal circuits is measured by the presence of motor evoked potentials or free run surface electromyography (EMG signal above baseline recorded from above muscles in response to TCSCS applied between spinous processes T10-11, T11-12, T12-L1, and L1-L2 (conus medullaris).
Measured: Week 1
Secondary outcomes (2)
Safety and efficacy during Urodynamic Testing (UDS)
Safety and efficacy of UDS is measured by presence of detrusor contractions (voiding function) while relaxing the EUS, i.e. to avoid detrusor sphincter dyssynergia and independently enhance EUS tone (storage function) without adverse cardiovascular effects.
Measured: Week 2 to 4
Safety and efficacy during Anorectal Manometry (ARM)
Safety and efficacy of ARM is measured by presence of an immediate increase in anorectal pressure without adverse cardiovascular effects.
Measured: Week 2 to 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Praxis Spinal Cord Institute, St. Paul's Hospital
- Responsible party
- Principal investigator, Andrei Krassioukov, University of British Columbia
- Investigators
- Andrei Krassioukov, MD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977284
- Sponsor's protocol ID
- H21-00781
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Neuroprosthesis for Autonomic Recovery After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04977284
- Acronym / sponsor ID
- H21-00781
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Praxis Spinal Cord Institute, St. Paul's Hospital
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 26 Jul 2021 (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.
This research study is being conducted to help explore the effects of non-invasive (non-surgical) spinal cord stimulation via sticky electrodes over the skin (transcutaneous spinal cord stimulation; TCSCS) on bowel, bladder and sexual function following spinal cord injury. Our primary aim is to determine the specific location and timing of TCSCS at various spinal cord levels in order to target bladder and bowel control (Study 1 and 2), and to assess the safety and effectiveness of TCSCS during bladder and bowel function assessments (Study 2 only). Participants may choose to participate in either Study 1 or 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TCSCS | Experimental | Device: DS7R, Digitimer, UK |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Resident of British Columbia, Canada with active provincial medical services plan
- Male or female, 18-65 years of age
- Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T10 spinal segment.
- >1-year post injury, at least 6 months from any spinal surgery.
- American Spinal Injury Association Impairment Scale (AIS) A, B.
Key exclusion criteria (9 listed)
- Presence of severe acute medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to clinically significant renal or hepatic disease; acute urinary tract infections; pressure sores; active heterotopic ossification; newly changed antidepressant medications [tricyclics]; or unstable diabetes.
- Recent treatment with OnabotulinumtoxinA into the detrusor muscle (relative contraindication).
- Ventilator dependent
- Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study.
- Intrathecal baclofen pump.
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 |
|---|---|---|
| DS7R, Digitimer, UKNon-surgical spinal cord stimulation will be applied and electrical activity of muscles will be recorded. | Device | TCSCS |
Primary outcome
Activation of spinal circuits
Time frame: Week 1
Activation of spinal circuits is measured by the presence of motor evoked potentials or free run surface electromyography (EMG signal above baseline recorded from above muscles in response to TCSCS applied between spinous processes T10-11, T11-12, T12-L1, and L1-L2 (conus medullaris).
2 secondary outcomes
Safety and efficacy during Urodynamic Testing (UDS)
Time frame: Week 2 to 4
Safety and efficacy during Anorectal Manometry (ARM)
Time frame: Week 2 to 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Andrei Krassioukov, MD, PhD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing DS7R, Digitimer, UK in people with Spinal Cord Injuries, run by University of British Columbia.
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 14 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura McCracken (604-675-8856, laura.mccracken@alumni.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activation of spinal circuits (time frame: Week 1). 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 26 Jul 2021.