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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSkolkovo Institute of Science and Technology

About this trial

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

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Peripheral Nerve Stimulation
  • Spinal cord stimulation
  • Dorsal Root Ganglion Stimulation
  • Motor Cortex Stimulation

Treatment groups

50 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators

Skolkovo Institute of Science and Technology

Lead sponsor

Motorica LLC

Collaborator

The Federal Center of Brain Research and Neurotechnologies

Collaborator