Noninvasive Neuroprosthesis for Autonomic Recovery After SCI

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: DS7R, Digitimer, UK

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura McCracken; Phone Number: 604-675-8856; Email: laura.mccracken@alumni.ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TCSCS	Device: DS7R, Digitimer, UK; Non-surgical spinal cord stimulation will be applied and electrical activity of muscles will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Week 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Week 2 to 4

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Praxis Spinal Cord Institute; St. Paul's Hospital
• Investigators: Principal Investigator: Andrei Krassioukov, MD, PhD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: H21-00781

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No