Noninvasive Neuroprosthesis for Autonomic Recovery After SCI
15. juli 2021 oppdatert av: Andrei Krassioukov, University of British Columbia
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
5
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Laura McCracken
- Telefonnummer: 604-675-8856
- E-post: laura.mccracken@alumni.ubc.ca
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: TCSCS
|
Non-surgical spinal cord stimulation will be applied and electrical activity of muscles will be recorded.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Activation of spinal circuits
Tidsramme: 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).
|
Week 1
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety and efficacy during Urodynamic Testing (UDS)
Tidsramme: Week 2 to 4
|
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)
Tidsramme: Week 2 to 4
|
Safety and efficacy of ARM is measured by presence of an immediate increase in anorectal pressure without adverse cardiovascular effects.
|
Week 2 to 4
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Andrei Krassioukov, MD, PhD, University of British Columbia
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. september 2021
Primær fullføring (Forventet)
30. april 2022
Studiet fullført (Forventet)
30. april 2022
Datoer for studieregistrering
Først innsendt
15. juli 2021
Først innsendt som oppfylte QC-kriteriene
15. juli 2021
Først lagt ut (Faktiske)
26. juli 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juli 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. juli 2021
Sist bekreftet
1. juli 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H21-00781
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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