Actively Recruiting
Neuromodulation Methods for Suppressing Phantom Limb Pain
Led by Skolkovo Institute of Science and Technology · Updated on 2024-10-16
50
Participants Needed
2
Research Sites
34 weeks
Total Duration
On this page
Sponsors
S
Skolkovo Institute of Science and Technology
Lead Sponsor
M
Motorica LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how different neuromodulation techniques can help reduce pain in people who have experienced upper or lower limb amputations. This study evaluates the use of electrical stimulation on peripheral nerves, the spinal cord, dorsal root ganglia, and motor cortex to manage phantom limb pain. The goal is to understand how these methods may relieve persistent chronic pain in this population. The study involves implanting electrodes in various locations depending on the neuromodulation method being tested. Peripheral Nerve Stimulation (PNS) implants electrodes near targeted peripheral nerves, Spinal Cord Stimulation (SCS) places electrodes in the epidural space near the spinal cord, Dorsal Root Ganglion Stimulation (DRGS) targets specific dorsal root ganglia, and Motor Cortex Stimulation (MCS) places electrodes over the motor cortex. Each method uses implanted devices to deliver electrical impulses aimed at altering pain signals. Participants will be monitored for up to one year, with assessments including pain levels using the Visual Analogue Scale (VAS) up to four months, and quality of life measured by the SF-36 up to one year. Other evaluations include sensory mapping, pain detection questionnaires, anxiety and depression scales, and sensory threshold tests. This comprehensive monitoring helps researchers understand the effects of neuromodulation on pain relief, mood, and sensory function in amputees.
CONDITIONS
Brief Title
Study of Phantom Limb Pain Suppression Using Neuromodulation Methods
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Amputation of the upper limb at the forearm or upper arm, or lower limb at the lower leg or thigh
- Age between 18 and 65 years
- Amputation occurred at least 6 months ago
- Persistent chronic pain rated 4 to 10 on the Visual Analog Scale (VAS)
- Not pregnant at the time of implantation (confirmed by pregnancy test for females)
- Signed consent to participate in the study
You will not qualify if you...
- Severe medical conditions that prevent surgery or study participation
- Psychiatric disorders including severe depression, suicidal tendencies, or history of suicide attempts
- Severe orthopedic deformity in the limb above amputation
- History of cancer
- History of epilepsy
- Complicated traumatic brain injury or history of stroke
- Inability to undergo electrostimulation due to other medical conditions
- Purulent-septic infections
- Drug addiction or history of drug addiction
- Congenital anomalies of upper limb development
- Anomalies in central or peripheral nervous system development
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day and immediate recovery period
Participants undergo surgical implantation of neuromodulation devices including motor cortex, spinal cord, peripheral nerve, or dorsal root ganglion stimulation electrodes.
1 surgical visit and several post-operative visits as needed
Duration - Up to 4 months
Participants receive electrical stimulation through the implanted devices to suppress phantom limb pain.
Regular visits for device adjustment and monitoring during treatment period
Duration - Up to 1 year
Participants are monitored for pain relief and other outcomes after the treatment phase ends.
Periodic visits for assessment of pain, sensory mapping, and quality of life
Trial Site Locations
Total: 2 locations
1
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia
Moscow, Moscow, Russia, 117997
Actively Recruiting
2
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia
Moscow, Russia, 117997
Actively Recruiting
Research Team
Y
Yury Matveenko
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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