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

Launched by SKOLKOVO INSTITUTE OF SCIENCE AND TECHNOLOGY · Nov 21, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for people experiencing phantom limb pain, which is the sensation of pain in a limb that has been amputated. Researchers are testing advanced techniques that use a device to stimulate nerves and provide sensory feedback, which may help reduce this pain and improve the quality of life for participants. The trial is currently recruiting individuals aged 18 to 65 who have had an amputation of either an arm or a leg for at least six months and have chronic pain rated between 4 and 10 on a pain scale.

If you or someone you know is considering participating, you should be aware that the study involves a surgical procedure to implant a device. Participants will receive close monitoring and care throughout the trial. However, there are specific eligibility criteria, and some individuals may not qualify if they have certain medical or psychiatric conditions. Overall, this study aims to find a better way to manage phantom limb pain and improve the daily lives of those affected.

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.