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

NCT06702904 | Recruiting

• 1 other identifier: Skoltech-CNBR5
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Keywords

Neuromodulation; Phantom limb pain; Neuropathic pain; Neurostimulation; Chronic pain; Peripheral nerve stimulation; PNS; Spinal cord stimulation; SCS; Dorsal root ganglion stimulation; DRG; Cortical stimulation; Amputation; Neurotechnology; Neuroprosthetics; BCI

Outcome Measures

Primary Outcomes (3)

• VAS

  The Visual Analog Scale (VAS) is a 10 cm line used to measure pain intensity. One end of the line represents \"no pain,\" while the other end signifies \"worst possible pain.\" The line can be either horizontal or vertical.

  up to 4 months

• SF-36

  The questionnaire consists of 36 items grouped into eight scales: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health. Each scale ranges from 0 to 100, where 100 represents full health. Higher scores indicate better quality of life, with two summary measures: physical and mental well-being.

  up to months

• DN 4

  The DN4 (Douleur Neuropathique 4) questionnaire is a diagnostic tool designed to identify neuropathic pain, caused by nerve damage. It includes 10 items divided into two sections. The first part consists of seven questions that assess the patient's pain symptoms, such as burning, tingling, electric shocks, or numbness. The second part involves a clinical examination where the physician tests for reduced sensitivity to touch and pinprick, as well as pain response to light brushing. Each item is scored with 1 point for "Yes" and 0 for "No." A total score of 4 or higher indicates a high probability of neuropathic pain.

  Up to 6 months

Secondary Outcomes (6)

• Sensory threshold change

  At least three measurements. 1 - First week after implantation, 2 - Up to three months after implantation, 3 - Up to five months after implantation

• Agency

  Up to 6 months

• Embodiment

  Up to 6 months

• Pain detect

  Up to 6 months

• Hospital Anxiety and Depression Scale (HADS)

  Up to 6 months

Other Outcomes (15)

• Object detection

  Up to 6 months

• Visual-motor integration

  Up to 4 months

• Value of sensory discrimination

  Up to once in two weeks

Study Arms (8)

Peripheral nerve stimulation for upper-limb prosthesis

EXPERIMENTAL

Procedure: Peripheral Nerve Stimulation

Peripheral nerve stimulation for lower-limb prosthesis

EXPERIMENTAL

Procedure: Peripheral Nerve Stimulation

Spinal cord stimulation for upper-limb prosthesis

EXPERIMENTAL

Procedure: Spinal cord stimulation

Spinal cord stimulation for lower-limb prosthesis

EXPERIMENTAL

Procedure: Spinal cord stimulation

Dorsal root ganglion stimulation for upper-limb prosthesis

EXPERIMENTAL

Procedure: Dorsal Root Ganglion Stimulation

Experimental: Dorsal root ganglion stimulation for lower-limb prosthesis

EXPERIMENTAL

Procedure: Dorsal Root Ganglion Stimulation

Motor Cortex Stimulation for upper-limb prosthesis

EXPERIMENTAL

Procedure: Motor Cortex Stimulation

Motor Cortex Stimulation for lower-limb prosthesis

EXPERIMENTAL

Procedure: Motor Cortex Stimulation

Interventions

Peripheral Nerve Stimulation 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; Peripheral nerve stimulation for upper-limb prosthesis

Spinal cord stimulation 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; Spinal cord stimulation for upper-limb prosthesis

Dorsal Root Ganglion Stimulation 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.

Dorsal root ganglion stimulation for upper-limb prosthesis; Experimental: Dorsal root ganglion stimulation for lower-limb prosthesis

Motor Cortex Stimulation 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; Motor Cortex Stimulation for upper-limb prosthesis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Skolkovo Institute of Science and Technology: lead
• Motorica LLC: collaborator
• The Federal Center of Brain Research and Neurotechnologies: collaborator

Study Sites (2)

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

Moscow, 117997, Russia

RECRUITING

Far Eastern Federal University

Moscow, 690922, Russia

RECRUITING

MeSH Terms

Conditions

Phantom Limb; Neuralgia; Chronic Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Yury Matvienko

CONTACT

+79163843070; yumedteam@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 25, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

RU (2)