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Recruiting NCT06644807

Study of Phantom Limb Pain Suppression Using Neuromodulation Methods

Trial Parameters

Condition Phantom Limb Pain
Sponsor Skolkovo Institute of Science and Technology
Study Type INTERVENTIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2024-09-01
Completion 2028-09-01
Interventions
Motor Cortex StimulationSpinal cord stimulationPeripheral Nerve Stimulation

Brief Summary

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.

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 electrostimu

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