Evaluating a neuroprosthesis to reduce phantom limb pain and improve quality of life
Official title: Evaluation of Neuroprosthesis with Sensory Feedback for Modulation of Phantom Limb Pain and Enhancing Quality of Life
Run by Skolkovo Institute of Science and Technology · NCT06702904 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Skolkovo Institute of Science and Technology Academic / other |
| Locations | 2 sites (Moscow and 1 other locations) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | September 1, 2028 |
| Study ends | May 1, 2029 |
| Registry record updated | November 25, 2024 |
| Trial ID | NCT06702904 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with severe psychiatric disorders, significant somatic pathology, or a history of certain medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies utilizing neuromodulation techniques for chronic pain management have shown promising results, indicating potential success for this approach.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Neuropathic pain after childhood amputation
This project sees how common phantom and residual limb neuropathic pain is and how it affects children and teens who had limb amputations.
-
Effects of magnetic stimulation on phantom limb pain in amputees
This study tests if using magnetic stimulation can help reduce phantom limb pain in people who have had upper limb amputations.
-
Preventing pain after lower limb amputation using targeted muscle reinnervation
This study is testing if a new technique called Targeted Muscle Reinnervation can help reduce pain after lower limb amputation compared to standard nerve handling.
-
Neuromodulation for relieving phantom limb pain
This study is testing different ways to use electrical stimulation to help people who have had a limb amputated and are suffering from phantom limb pain feel better.
-
Treatment for phantom limb pain using visual simulation therapy
This study is testing if a new therapy using visual simulations can help amputees with phantom limb pain feel less discomfort compared to standard care.
-
Reducing phantom limb pain in amputees
This study is testing two different rehabilitation programs to see which one helps amputees with phantom limb pain feel better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.