Study of Phantom Limb Pain Suppression Using Neuromodulation Methods

Skolkovo Institute of Science and Technology

Status: Enrolling

Conditions: Phantom Limb Pain

Treatments: Procedure: Peripheral Nerve Stimulation; Procedure: Dorsal Root Ganglion Stimulation; Procedure: Spinal cord stimulation; Procedure: Motor Cortex Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06644807

Skoltech-CNBR4

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

Peripheral nerve stimulation

Experimental group

Treatment:

Procedure: Peripheral Nerve Stimulation

Spinal cord stimulation

Experimental group

Treatment:

Procedure: Spinal cord stimulation

Motor Cortex Stimulation

Experimental group

Treatment:

Procedure: Motor Cortex Stimulation

Dorsal Root Ganglion Stimulation

Experimental group

Treatment:

Procedure: Dorsal Root Ganglion Stimulation