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Recruiting NCT06644807

Study of Phantom Limb Pain Suppression Using Neuromodulation Methods

No phase Interventional Phantom Limb Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Motor Cortex Stimulation, Spinal cord stimulation, Peripheral Nerve Stimulation, Dorsal Root Ganglion Stimulation.
Who it may be relevant to
Registry conditions: Phantom Limb Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Neuromodulation Methods for Suppressing Phantom Limb Pain

Overview

This study assesses the effectiveness of neuromodulation in alleviating pain through the stimulation of peripheral nerves. The research involves implanting electrodes for test stimulation of peripheral nerves (PNS - Peripheral Nerve Stimulation), spinal cord (SCS - Spinal Cord Stimulation), dorsal root ganglia (DRGS - Dorsal Root Ganglion Stimulation), and motor cortex (MCS - Motor Cortex Stimulation). The study aims to explore the use of neuromodulation for pain relief in patients experiencing pain due to upper or lower limb amputation.

Interventions

  • 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
  • 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.
  • Procedure 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.
  • 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.

Primary outcome measures

  • Visual analogue scale (VAS) [Time frame: Up to 4 months]
  • SF-36 [Time frame: up to 1 year]
Secondary outcome measures (5)
  • Sensory mapping [Time frame: up to 4 months]
  • Pain detect [Time frame: Up 1 year]
  • DN 4 [Time frame: up to 1 year]
  • Hospital Anxiety and Depression Scale, HADS [Time frame: up to 1 year]
  • Sensory threshold [Time frame: up to 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Russia · 2 centers
  • Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological A — Moscow
  • Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological A — Moscow

Identifiers

NCT: NCT06644807 · Skoltech-CNBR4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗