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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Russian Federation
Far Eastern Federal University
RECRUITING
Moscow
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia
RECRUITING
Moscow
Contact Information
Primary
Yury Matvienko
yumedteam@gmail.com
+79163843070
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2029-05-01
Participants
Target number of participants: 50
Treatments
Experimental: Peripheral nerve stimulation for upper-limb prosthesis
Experimental: Peripheral nerve stimulation for lower-limb prosthesis
Experimental: Spinal cord stimulation for upper-limb prosthesis
Experimental: Spinal cord stimulation for lower-limb prosthesis
Experimental: Dorsal root ganglion stimulation for upper-limb prosthesis
Experimental: Experimental: Dorsal root ganglion stimulation for lower-limb prosthesis
Experimental: Motor Cortex Stimulation for upper-limb prosthesis
Experimental: Motor Cortex Stimulation for lower-limb prosthesis
Sponsors
Collaborators: The Federal Center of Brain Research and Neurotechnologies, Motorica LLC
Leads: Skolkovo Institute of Science and Technology

This content was sourced from clinicaltrials.gov

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