Medtronic Inceptiv™ Closed-Loop DTM Spinal Cord Stimulation for Painful Diabetic Peripheral Neuropathy

Официальное название

Feasibility and Therapeutic Efficacy Study of Medtronic's DTM-Closed-Loop Integrated SCS Technology for Managing Diabetic Peripheral Neuropathic Pain (DPN)

Обзор

This study is conducted to evaluate a new way of using spinal cord stimulation (SCS) in people with painful diabetic peripheral neuropathy (DPN). The device used is the Medtronic Inceptiv SCS, which is already approved by the U.S. FDA for treatment of chronic pain. In this study, the system will be programmed to deliver Differential Target Multiplexed (DTM) stimulation with closed-loop feedback using signals from the spinal cord (ECAPs). Up to 25 participants will take part in the study, beginning with a short trial phase and continuing to a permanent implant if the trial is successful. Participants will be followed for 12 months after implant. The main goal is to see whether this therapy can safely and effectively reduce pain in people with diabetic neuropathy. Other measures include physical function, symptom profiles, treatment satisfaction, and monitoring for any side effects.

Вмешательства

• Устройство Implantable SCS with Closed Loop mechanism
  Participants will be treated with an implantable spinal cord stimulation system programmed to deliver differentially multiplexed targeting pulse program with closed-loop adjustment using evoked compound action potential feedback. All subjects will first undergo a short percutaneous trial phase of spinal cord stimulation. Those who meet trial success criteria will then receive permanent implantation with a paddle lead and the implantable pulse generator. After implantation, closed-loop DTM therap

Первичные конечные точки

• Change in Pain Intensity on the Visual Analog Scale (VAS, 0-10) from Baseline to 12 Months [Срок оценки: Baseline; End of Trial (~7 days after trial lead placement); 1, 3, 6, and 12 months after permanent implant. Primary time point: 12 months.]

Критерии участия

• Inclusion Criteria:

• Adults ≥19 years.
• Confirmed DPN with EMG evidence of peripheral nerve dysfunction.
• Persistent lower-limb neuropathic pain VAS ≥6 for ≥6 months despite prior pharmacologic therapy.
• HbA1c ≤8.5% within 3 months prior to enrollment.
• No prior SCS/neuromodulation therapy; medically eligible for paddle lead implantation with Inceptiv IPG.
• Insurance approval or financial ability to cover SCS therapy; able to consent and comply.
• Exclusion Criteria:

(a) Non-diabetic neuropathies other conditions contributing to lower-limb pain. (b) Contraindications to surgical implantation.

(c) History of neurostimulation therapy; active substance abuse or uncontrolled psychiatric illness.

(d) Pregnancy or plans for pregnancy; known allergy to device materials; inability to provide informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Grand Island Pain Relief Center — Grand Island

Идентификаторы

NCT: NCT07209514 · IIS-25-MTR-001 · ERP #14060

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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