Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury

University of British Columbia

Status: Enrolling

Conditions: Neurogenic Bowel Dysfunction; Sexual Dysfunction; Autonomic Dysreflexia; Spinal Cord Injury; Orthostatic Hypotension; Neurogenic Bladder Dysfunction; Autonomic Dysfunction

Treatments: Device: TESCoN or SCONE device - Lumbosacral stimulation; Device: TESCoN or SCONE device - Thoracic stimulation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05369520

H22-00365

CDMRP-SC210078 (Other Grant/Funding Number)

Details and patient eligibility

About

This study is a pilot clinical trial to explore the efficacy of transcutaneous spinal cord stimulation (TCSCS) (proof-of-concept) in mitigating crucial autonomic dysfunctions that impact the health-related quality of life of individuals with spinal cord injury (SCI).

Full description

This is a pilot clinical trial to explore the efficacy of TCSCS (proof-of-concept) in mitigating crucial autonomic dysfunctions that impact the health-related quality of life of individuals with SCI. A total of 30 eligible participants will be recruited and attend forty-two visits. All experiments will be performed at ICORD (Primary site) and the Brenda and David McLean Integrated Spine Clinic (SCI clinic), with the exception of anorectal manometry testing conducted at the Gastroenterology Clinic, St Paul's Hospital (GI clinic).

Following completion of screening and signing informed consent forms (visit 1), participants will undergo spatiotemporal mapping of spinal cord segments known to be involved in blood pressure, lower urinary tract and bowel control (visit 2). Following mapping, all individuals will undergo baseline functional assessments with and without TCSCS during 5 visits (visits 3-7), over a period of 4 weeks. To minimize the order effect, the functional assessments will be performed in a randomized order. Following baseline assessments, using a randomized counter-balanced approach, individuals will be allocated in two distinct pathways; the participants in Groups 1 and 2 will receive 8 weeks of TCSCS (3 times/week) at either mid/low thoracic or lumbosacral spinal cord levels respectively (visits 8- 31). Following long-term TCSCS, participants will undergo functional assessments during 5 visits (visits 32- 36) over a period of 4 weeks. In order to evaluate the persistent effects of TCSCS, all assessments will be repeated 8 weeks after cessation of the therapy.

Enrollment: 30 estimated patients

Sex: All

Ages: 19 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Resident of British Columbia, Canada with active provincial medical services plan.

2. Male or female, 19-60 years of age.

3. Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment.

4. >1-year post injury, at least 6 months from any spinal surgery.

5. American Spinal Injury Association Impairment Scale (AIS) A, B.

6. Stable management of spinal cord related clinical issues (i.e., spasticity management).

7. Experience bladder, or bowel, or sexual dysfunction.

8. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.

9. For women of childbearing potential, not intending to become pregnant, currently pregnant, or lactating. The following conditions apply:

   1. 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. Use adequate contraception, or complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.
   3. If using combined hormonal contraception, a stable regimen during the period of the trial and for at least 28 days after completion of treatment.

10. For sexually active males with female partners of childbearing potential, use adequate contraception, or complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.

11. Must provide informed consent.

12. Willing and able to comply with all clinic visits and study-related procedures.

13. 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).

Exclusion criteria

1. Ventilator dependent.
2. Signs of lower motor neuron damage (i.e. concomitant conus medullaris/cauda equina injury).
3. Severe anemia or hypovolemia as measured by hematocrit via blood test in the last six months.
4. History of cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
5. History of seizures/epilepsy or recurring headaches.
6. Clinically significant, unmanaged, depression (to be screened) or ongoing drug abuse.
7. Intrathecal baclofen pump.
8. Oral baclofen dose greater than 60mg.
9. Individuals that have received intradetrusor or intrasphincter onabotulinumtoxinA injections within 6 months of baseline.
10. Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.
11. Past electrode implantation surgery.
12. Member of the investigational team or his/her immediate family.
13. Presence of severe acute medical issue and use of any specific medication or treatment that, in the investigator's judgement, would adversely affect the participant's participation in the study.
14. Known allergies or sensitivities to both blue dye and beetroot powder.
15. Known or suspected gastrointestinal obstruction.
16. Persons with active inflammatory bowel disease or a history of bowel perforation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Group 1 - Thoracic stimulation

Experimental group

Description:

Participants will receive 8 weeks TCSCS at the mid/low thoracic spinal cord levels.

Treatment:

Device: TESCoN or SCONE device - Thoracic stimulation

Group 2- Lumbosacral stimulation

Experimental group

Description:

Participants will receive 8 weeks TCSCS at the lumbosacral spinal cord levels.

Treatment:

Device: TESCoN or SCONE device - Lumbosacral stimulation