Intraoperative Peripheral Nerve Stimulation
17 juni 2026 uppdaterad 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.
Studieöversikt
Status
Indragen
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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North Carolina
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Winston-Salem, North Carolina, Förenta staterna, 27157
- Atrium Health Wake Forest Baptist
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
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Experimentell: 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
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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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Medical Research Council Scale for Muscle Strength Score
Tidsram: 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
|
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Medical Research Council Scale for Muscle Strength Score
Tidsram: 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
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Medical Research Council Scale for Muscle Strength Score
Tidsram: 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
|
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Medical Research Council Scale for Muscle Strength Score
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Oswestry Disability Index Score
Tidsram: 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).
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Baseline, Month 1, Month 3, Year 1
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Patient Reported Outcomes Measurement Information System (PROMIS) Score
Tidsram: Baseline, Month 1, Month 3, Year 1
|
Score range from 20-80 with high scores indicating better function while lower scores indicate poorer function.
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Baseline, Month 1, Month 3, Year 1
|
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Disabilities of the Arm Shoulder and Hand Score
Tidsram: 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
|
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Short Form Health Survey Score
Tidsram: 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.
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Baseline, Month 1, Month 3, Year 1
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Christopher Dibble, MD, Atrium Health Wake Forest Baptist
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
1 juni 2029
Avslutad studie (Beräknad)
1 juni 2029
Studieregistreringsdatum
Först inskickad
11 maj 2026
Först inskickad som uppfyllde QC-kriterierna
11 maj 2026
Första postat (Faktisk)
18 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juni 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00149854
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
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Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
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