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

Skolkovo Institute of Science and Technology

Status: Enrolling

Conditions: Phantom Limb Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06702904

Skoltech-CNBR5

Details and patient eligibility

About

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.

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: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 8 patient groups

Peripheral nerve stimulation for upper-limb prosthesis

Experimental group

Treatment:

Procedure: Peripheral Nerve Stimulation

Peripheral nerve stimulation for lower-limb prosthesis

Experimental group

Treatment:

Procedure: Peripheral Nerve Stimulation

Spinal cord stimulation for upper-limb prosthesis

Experimental group

Treatment:

Procedure: Spinal cord stimulation

Spinal cord stimulation for lower-limb prosthesis

Experimental group

Treatment:

Procedure: Spinal cord stimulation

Dorsal root ganglion stimulation for upper-limb prosthesis

Experimental group

Treatment:

Procedure: Dorsal Root Ganglion Stimulation

Experimental: Dorsal root ganglion stimulation for lower-limb prosthesis

Experimental group

Treatment:

Procedure: Dorsal Root Ganglion Stimulation

Motor Cortex Stimulation for upper-limb prosthesis

Experimental group

Treatment:

Procedure: Motor Cortex Stimulation

Motor Cortex Stimulation for lower-limb prosthesis

Experimental group

Treatment:

Procedure: Motor Cortex Stimulation