Intraoperative Peripheral Nerve Stimulation
17. juni 2026 oppdatert av: Wake Forest University Health Sciences
Intraoperative Electrical Stimulation to Accelerate Functional Recovery of Peripheral Nerves After Decompressive Surgery
The purpose of this research study is to find out if using direct electrical stimulation during surgery is safe and helpful for people with nerve problems caused by compressed nerves.
Studieoversikt
Status
Tilbaketrukket
Forhold
Detaljert beskrivelse
The overall objective of this study is to establish the safety and utility of direct electrical stimulation as part of surgical intervention for compressive neuropathies of peripheral nerves and nerve roots.
Stimulation will be provided with the Checkpoint Guardian which is a single-use, hand-held device cleared for the stimulation of exposed motor nerves or muscle tissue to locate and identify nerves.
The central hypothesis is that electrical stimulation of the peripheral nerve or spinal nerve root at the time of decompressive surgery will improve motor strength and functional outcomes for patients.
Studietype
Intervensjonell
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
North Carolina
-
Winston-Salem, North Carolina, Forente stater, 27157
- Atrium Health Wake Forest Baptist
-
-
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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Nerve root stimulation arm: Clinical and radiographic findings of compressive neuropathy at the level of the nerve root, including myelopathy and/ or radiculopathy, who are planning for minimally invasive or open spine surgery to decompress the nerve.
- Peripheral nerve stimulation arm: Compressive peripheral neuropathy, including cubital tunnel, carpal tunnel and peroneal nerve compression who are planning to undergo surgical decompression in the affected upper extremity.
Exclusion Criteria:
- Patients that had previous nerve transfers for cervical spinal cord injury or tendon transfers, as they would not benefit from this procedure.
- Any implanted electronic devices, including pacemakers
- Pregnant or nursing
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: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Nerve Root Stimulation Arm
patients undergoing spine surgery for decompression of the nerve root
|
in addition to standard of care surgical decompression will receive 10 minutes of electrical stimulation at an amplitude of 2 mA with the Checkpoint nerve stimulator to the nerve root at the time of decompressive surgery
|
|
Eksperimentell: Peripheral Nerve Stimulation Arm
patients undergoing peripheral nerve decompression in an upper extremity
|
in addition to standard of care surgical decompression will receive 10 minutes of electrical stimulation at an amplitude of 2 mA with the Checkpoint nerve stimulator to the peripheral nerve at the time of decompressive surgery
|
|
Aktiv komparator: Nerve Root Control Arm
patients undergoing spine surgery for decompression of the nerve root
|
standard surgical treatment when undergoing spine surgery for decompression of the nerve root
|
|
Aktiv komparator: Peripheral Nerve Control Arm
patients undergoing peripheral nerve decompression in an upper extremity
|
standard surgical treatment when undergoing peripheral nerve decompression in an upper extremity
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Medical Research Council Scale for Muscle Strength Score
Tidsramme: Baseline
|
The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.
|
Baseline
|
|
Medical Research Council Scale for Muscle Strength Score
Tidsramme: Month 1
|
The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.
|
Month 1
|
|
Medical Research Council Scale for Muscle Strength Score
Tidsramme: Month 3
|
The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.
|
Month 3
|
|
Medical Research Council Scale for Muscle Strength Score
Tidsramme: Year 1
|
The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.
|
Year 1
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Oswestry Disability Index Score
Tidsramme: Baseline, Month 1, Month 3, Year 1
|
Participants in the nerve root stimulation arm will be given the The Oswestry Disability Index which is a self-administered questionnaire used to measure permanent functional disability caused by low back pain.
It consists of 10 items covering pain and physical activities, with scores ranging from 0 (no disability) to 100 (maximum disability).
|
Baseline, Month 1, Month 3, Year 1
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Score
Tidsramme: Baseline, Month 1, Month 3, Year 1
|
Score range from 20-80 with high scores indicating better function while lower scores indicate poorer function.
|
Baseline, Month 1, Month 3, Year 1
|
|
Disabilities of the Arm Shoulder and Hand Score
Tidsramme: Baseline, Month 1, Month 3, Year 1
|
Participants in the peripheral nerve stimulation arm will be given the Disabilities of the Arm Shoulder and Hand questionnaire which is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales.
Scores range from 0 (no disability) to 100 (most severe disability).
|
Baseline, Month 1, Month 3, Year 1
|
|
Short Form Health Survey Score
Tidsramme: Baseline, Month 1, Month 3, Year 1
|
Participants in the peripheral nerve stimulation arm will be given the SF-36.
There are 36 items with score range from 0-100 with a higher score indicating a better functional state with few limitations/disabilities while a low score indicates a poorer functional state with more disability and limitations.
|
Baseline, Month 1, Month 3, Year 1
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Christopher Dibble, MD, Atrium Health Wake Forest Baptist
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 (Antatt)
1. juni 2026
Primær fullføring (Antatt)
1. juni 2029
Studiet fullført (Antatt)
1. juni 2029
Datoer for studieregistrering
Først innsendt
11. mai 2026
Først innsendt som oppfylte QC-kriteriene
11. mai 2026
Først lagt ut (Faktiske)
18. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00149854
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
Ja
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .