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

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

This clinical trial is designed to assess the effectiveness of advanced neuromodulation techniques in reducing phantom limb pain by improving sensory feedback in bionic prostheses. The study will explore the use of Peripheral Nerve Stimulation to evaluate their impact on pain relief and sensory restoration. The trial aims the development of neuroprostheses that can provide sensory feedback through stimulation.

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.