Evaluation of Neuroprosthesis with Sensory Feedback for Modulation of Phantom Limb Pain and Enhancing Quality of Life

Обзор

This clinical trial is designed to assess the effectiveness of advanced neuromodulation techniques in reducing phantom limb pain by improving sensory feedback in bionic prostheses. The study will explore the use of Peripheral Nerve Stimulation to evaluate their impact on pain relief and sensory restoration. The trial aims the development of neuroprostheses that can provide sensory feedback through stimulation.

Вмешательства

• Процедура Peripheral Nerve Stimulation
  Peripheral Nerve Stimulation (PNS) is a neuromodulation technique used to treat chronic pain. The procedure starts with a preoperative assessment, including imaging to identify the target peripheral nerve. Under local anesthesia, a thin, insulated electrode is implanted near the nerve, usually with the help of fluoroscopic or ultrasound guidance for precision.
• Процедура Spinal cord stimulation
  Spinal Cord Stimulation (SCS) is a neuromodulation that involves the implantation of a device that delivers electrical impulses to the spinal cord through an electrode placed in the epidural space. The stimulation alters pain signals before they reach the brain, effectively masking or reducing the sensation of pain.
• Процедура Dorsal Root Ganglion Stimulation
  Dorsal Root Ganglion Stimulation (DRGS) is a targeted neuromodulation technique for managing chronic pain. The procedure begins with a thorough preoperative assessment, including imaging to locate the specific dorsal root ganglion (DRG) associated with the pain. Under local anesthesia, a small electrode is implanted near the DRG. This is done through a minimally invasive procedure, often guided by fluoroscopy or CT imaging to ensure precise placement.
• Процедура Motor Cortex Stimulation
  Motor Cortex Stimulation (MCS) is a neuromodulation technique that involves the surgical implantation of electrodes over the motor cortex, typically targeting the precentral gyrus, to deliver electrical stimulation. The procedure involves placing an electrode grid or strip on the dura mater overlying the motor cortex, which is identified via neuroimaging techniques such as functional MRI or neuronavigation. Once implanted, the electrodes are connected to an implanted pulse generator (IPG), which

Первичные конечные точки

• VAS [Срок оценки: up to 4 months]
• SF-36 [Срок оценки: up to months]
• DN 4 [Срок оценки: Up to 6 months]

Вторичные конечные точки (6)

• Sensory threshold change [Срок оценки: At least three measurements. 1 - First week after implantation, 2 - Up to three months after implantation, 3 - Up to five months after implantation]
• Agency [Срок оценки: Up to 6 months]
• Embodiment [Срок оценки: Up to 6 months]
• Pain detect [Срок оценки: Up to 6 months]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Up to 6 months]
• Ownership [Срок оценки: Up to 6 months]

Критерии участия

Критерии включения

• Amputation of the upper limb at the level of the forearm or upper arm, or amputation of the lower limb at the level of the lower leg or thigh.
• Age between 18 and 65 years.
• Duration since amputation is at least 6 months.
• Presence of persistent chronic pain syndrome rated between 4 and 10 on the Visual Analog Scale (VAS).
• Absence of pregnancy at the time of implantation, confirmed by a pregnancy test (for female participants only).
• Signed consent to participate in the study.

Критерии исключения

• Presence of severe somatic pathology that hinders surgical treatment and participation in the study.
• Presence of psychiatric disorders (including a history of), severe depression, suicidal tendencies, or a history of suicide attempts.
• Presence of severe orthopedic deformity in the limb above the level of amputation.
• History of cancer.
• History of epilepsy.
• Complicated traumatic brain injury (TBI) or a history of stroke.
• Inability to undergo electrostimulation due to other somatic pathology.
• Purulent-septic pathology.
• Drug addiction (including a history of).
• Congenital anomaly of upper limb development.
• Anomalies in the development of the central and peripheral nervous systems.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Россия · 2 центра

• Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological A — Moscow
• Far Eastern Federal University — Moscow

Идентификаторы

NCT: NCT06702904 · Skoltech-CNBR5

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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