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Evaluation of Neuroprosthesis with Sensory Feedback for Modulation of Phantom Limb Pain and Enhancing Quality of Life | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT06702904•Skolkovo Institute of Science and Technology

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

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.
+1 more criteria

Locations (2)

Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia

Moscow, Russia

Far Eastern Federal University

Moscow, Russia

Key Dates

Start Date

December 1, 2024

Primary Completion Date

September 1, 2028

Completion Date

May 1, 2029

Last Updated

November 25, 2024

Enrollment

ESTIMATED participants

Conditions

Phantom Limb Pain

Interventions

Peripheral Nerve Stimulation

PROCEDURE

Spinal cord stimulation

PROCEDURE

Dorsal Root Ganglion Stimulation

PROCEDURE

Motor Cortex Stimulation

PROCEDURE

Contacts

Yury Matvienko

CONTACT

+79163843070 yumedteam@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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