NCT06644807 Study of Phantom Limb Pain Suppression Using Neuromodulation Methods
| NCT ID | NCT06644807 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Skolkovo Institute of Science and Technology |
| Condition | Phantom Limb Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-09-01 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study assesses the effectiveness of neuromodulation in alleviating pain through the stimulation of peripheral nerves. The research involves implanting electrodes for test stimulation of peripheral nerves (PNS - Peripheral Nerve Stimulation), spinal cord (SCS - Spinal Cord Stimulation), dorsal root ganglia (DRGS - Dorsal Root Ganglion Stimulation), and motor cortex (MCS - Motor Cortex Stimulation). The study aims to explore the use of neuromodulation for pain relief in patients experiencing pain due to upper or lower limb amputation.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06644807 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Phantom Limb Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06644807 currently recruiting?
Yes, NCT06644807 is actively recruiting participants. Contact the research team at medtream@gmail.com for enrollment information.
Where is the NCT06644807 trial being conducted?
This trial is being conducted at Moscow, Russia, Moscow, Russia.
Who is sponsoring the NCT06644807 clinical trial?
NCT06644807 is sponsored by Skolkovo Institute of Science and Technology. The trial plans to enroll 50 participants.