Study of Phantom Limb Pain Suppression Using Neuromodulation Methods
ConditionPhantom Limb Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSkolkovo Institute of Science and Technology
About this trial
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
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
- Motor Cortex Stimulation
- Spinal cord stimulation
- Peripheral Nerve Stimulation
- Dorsal Root Ganglion Stimulation
Treatment groups
50 Participants
are divided into 4 treatment groupsSponsors and collaborators
Skolkovo Institute of Science and Technology
Lead sponsor
Motorica LLC
Collaborator
Federal center of brain research and neurotechnologies
Collaborator
Source ClinicalTrials.gov