Study of Phantom Limb Pain Suppression Using Neuromodulation Methods

Launched by SKOLKOVO INSTITUTE OF SCIENCE AND TECHNOLOGY · Oct 14, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how certain techniques, called neuromodulation methods, can help relieve phantom limb pain in individuals who have had an arm or leg amputated. Phantom limb pain is when a person feels pain in a limb that is no longer there. The study involves applying gentle electrical stimulation to specific nerves in the body to see if it can reduce this pain. Participants will have different types of stimulation, including methods that target the spinal cord and other areas of the nervous system.

To join the study, participants should be between 18 and 65 years old and have experienced the loss of an arm or leg at least six months prior. They must also be dealing with ongoing pain, rated between 4 and 10 on a scale where 0 means no pain and 10 means the worst pain possible. It's important to note that some individuals may not qualify to participate, especially if they have certain medical or psychological conditions. If eligible, participants can expect to undergo a procedure where electrodes are placed to stimulate the nerves, and they will be monitored for changes in their pain levels throughout the study.

Gender

ALL

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.