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

Last updated: November 21, 2024
Sponsor: Skolkovo Institute of Science and Technology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Treatment

Spinal cord stimulation

Motor Cortex Stimulation

Peripheral Nerve Stimulation

Clinical Study ID

NCT06702904
Skoltech-CNBR5
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Amputation of the upper limb at the level of the forearm or upper arm, or amputationof 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 VisualAnalog Scale (VAS).

  • Absence of pregnancy at the time of implantation, confirmed by a pregnancy test (forfemale participants only).

  • Signed consent to participate in the study.

Exclusion

Exclusion Criteria:

  • Presence of severe somatic pathology that hinders surgical treatment andparticipation 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.

Study Design

Total Participants: 50
Treatment Group(s): 4
Primary Treatment: Spinal cord stimulation
Phase:
Study Start date:
December 01, 2024
Estimated Completion Date:
May 01, 2029

Connect with a study center

  • Far Eastern Federal University

    Moscow, 690922
    Russian Federation

    Active - Recruiting

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

    Moscow, 117997
    Russian Federation

    Active - Recruiting

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