Evaluating a neuroprosthesis to reduce phantom limb pain and improve quality of life
Evaluation of Neuroprosthesis with Sensory Feedback for Modulation of Phantom Limb Pain and Enhancing Quality of Life
This study is testing a new device to see if it can help people with phantom limb pain feel better and improve their experience with bionic limbs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Skolkovo Institute of Science and Technology Academic / other |
| Locations | 2 sites (Moscow and 1 other locations) |
| Trial ID | NCT06702904 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the effectiveness of advanced neuromodulation techniques, specifically Peripheral Nerve Stimulation, in alleviating phantom limb pain and enhancing sensory feedback in bionic prostheses. Participants will undergo various interventions, including spinal cord stimulation and motor cortex stimulation, to evaluate their impact on pain relief and sensory restoration. The study aims to develop neuroprostheses that can provide sensory feedback through stimulation, potentially leading to improved quality of life for individuals with limb amputations.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 to 65 who have experienced an amputation of the upper or lower limb at least six months prior and suffer from chronic pain rated between 4 and 10 on the Visual Analog Scale.
Not a fit: Patients with severe psychiatric disorders, significant somatic pathology, or a history of certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce phantom limb pain and enhance the quality of life for amputees.
How similar studies have performed: Other studies utilizing neuromodulation techniques for chronic pain management have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Moscow and 1 other locations
- Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia — Moscow, Russia (Recruiting)
- Far Eastern Federal University — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Yury Matvienko
- Email: yumedteam@gmail.com
- Phone: +79163843070
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.