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| Name | Class |
|---|---|
| Praxis Spinal Cord Institute | OTHER |
| St. Paul's Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCSCS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS7R, Digitimer, UK | Device | Non-surgical spinal cord stimulation will be applied and electrical activity of muscles will be recorded. |
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| 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 |
| 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 |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura McCracken | Contact | 604-675-8856 | laura.mccracken@alumni.ubc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Andrei Krassioukov, MD, PhD | University of British Columbia | Principal Investigator |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 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 |
| D014947 | Wounds and Injuries |