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

NCT ID: NCT06702904

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2029-05-01

Brief Summary

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.

Conditions

Phantom Limb Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Peripheral nerve stimulation for upper-limb prosthesis

Group Type: EXPERIMENTAL

Peripheral Nerve Stimulation

Intervention Type: PROCEDURE

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.

Peripheral nerve stimulation for lower-limb prosthesis

Group Type: EXPERIMENTAL

Peripheral Nerve Stimulation

Intervention Type: PROCEDURE

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.

Spinal cord stimulation for upper-limb prosthesis

Group Type: EXPERIMENTAL

Spinal cord stimulation

Intervention Type: PROCEDURE

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.

Spinal cord stimulation for lower-limb prosthesis

Group Type: EXPERIMENTAL

Spinal cord stimulation

Intervention Type: PROCEDURE

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.

Dorsal root ganglion stimulation for upper-limb prosthesis

Group Type: EXPERIMENTAL

Dorsal Root Ganglion Stimulation

Intervention Type: PROCEDURE

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.

Experimental: Dorsal root ganglion stimulation for lower-limb prosthesis

Group Type: EXPERIMENTAL

Dorsal Root Ganglion Stimulation

Intervention Type: PROCEDURE

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.

Motor Cortex Stimulation for upper-limb prosthesis

Group Type: EXPERIMENTAL

Motor Cortex Stimulation

Intervention Type: PROCEDURE

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 delivers adjustable electrical impulses.

Motor Cortex Stimulation for lower-limb prosthesis

Group Type: EXPERIMENTAL

Motor Cortex Stimulation

Intervention Type: PROCEDURE

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 delivers adjustable electrical impulses.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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 delivers adjustable electrical impulses.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Motorica LLC

UNKNOWN

Sponsor Role: collaborator

The Federal Center of Brain Research and Neurotechnologies

UNKNOWN

Sponsor Role: collaborator

Skolkovo Institute of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia

Moscow, , Russia

Site Status: RECRUITING

Far Eastern Federal University

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Yury Matvienko

Role: CONTACT

yumedteam@gmail.com

+79163843070

Facility Contacts

Artur Biktimirov, MD

Role: primary

biartur2006@yandex.ru

+79149651488

Artur Biktimirov, MD

Role: primary

biartur2006@yandex.ru

+79149651488

Other Identifiers

Skoltech-CNBR5

Identifier Type: -

Identifier Source: org_study_id