Neuromodulation for relieving phantom limb pain
Neuromodulation Methods for Suppressing 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.
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, Moscow and 1 other locations) |
| Trial ID | NCT06644807 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of various neuromodulation techniques, including Motor Cortex Stimulation, Spinal Cord Stimulation, Peripheral Nerve Stimulation, and Dorsal Root Ganglion Stimulation, in alleviating phantom limb pain in patients who have undergone limb amputation. Participants will have electrodes implanted to stimulate peripheral nerves and other targeted areas to assess pain relief. The study focuses on individuals experiencing chronic pain at least six months post-amputation, aiming to provide a novel approach to managing this debilitating condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who have experienced an amputation of the upper or lower limb 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 study could significantly reduce phantom limb pain, improving the quality of life for amputees.
How similar studies have performed: While neuromodulation techniques have been explored in various contexts, this specific application for phantom limb pain is relatively novel and has not been extensively tested in prior studies.
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, Moscow and 1 other locations
- Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia — Moscow, Moscow, Russia (Recruiting)
- Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Yury Matveenko
- Email: medtream@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.