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Noninvasive Neuroprosthesis for Autonomic Recovery After SCI

Primary Purpose

Spinal Cord Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DS7R, Digitimer, UK
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • 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:

    1. 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.
    2. 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    TCSCS

    Arm Description

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    July 15, 2021
    Last Updated
    July 15, 2021
    Sponsor
    University of British Columbia
    Collaborators
    Praxis Spinal Cord Institute, St. Paul's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04977284
    Brief Title
    Noninvasive Neuroprosthesis for Autonomic Recovery After SCI
    Official Title
    Noninvasive Neuroprosthesis for Autonomic Recovery After Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    April 30, 2022 (Anticipated)
    Study Completion Date
    April 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of British Columbia
    Collaborators
    Praxis Spinal Cord Institute, St. Paul's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    5 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TCSCS
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    DS7R, Digitimer, UK
    Intervention Description
    Non-surgical spinal cord stimulation will be applied and electrical activity of muscles will be recorded.
    Primary Outcome Measure Information:
    Title
    Activation of spinal circuits
    Description
    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).
    Time Frame
    Week 1
    Secondary Outcome Measure Information:
    Title
    Safety and efficacy during Urodynamic Testing (UDS)
    Description
    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.
    Time Frame
    Week 2 to 4
    Title
    Safety and efficacy during Anorectal Manometry (ARM)
    Description
    Safety and efficacy of ARM is measured by presence of an immediate increase in anorectal pressure without adverse cardiovascular effects.
    Time Frame
    Week 2 to 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laura McCracken
    Phone
    604-675-8856
    Email
    laura.mccracken@alumni.ubc.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrei Krassioukov, MD, PhD
    Organizational Affiliation
    University of British Columbia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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