Actively Recruiting
Study of Phantom Limb Pain Suppression Using Neuromodulation Methods
Led by Skolkovo Institute of Science and Technology · Updated on 2024-10-16
50
Participants Needed
2
Research Sites
243 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
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.
CONDITIONS
Official 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
- At least 6 months since amputation
- Persistent chronic pain rated 4 to 10 on the Visual Analog Scale (VAS)
- Not pregnant at time of implantation (for female participants), confirmed by pregnancy test
- Signed consent to participate in the study
You will not qualify if you...
- Severe health conditions that prevent surgical treatment or study participation
- Psychiatric disorders, including severe depression, suicidal tendencies, or history of suicide attempts
- Severe orthopedic deformity in the limb above the amputation
- History of cancer
- History of epilepsy
- Complicated traumatic brain injury or history of stroke
- Inability to undergo electrostimulation due to other health issues
- Presence of purulent-septic pathology
- Drug addiction or history of drug addiction
- Congenital anomaly of upper limb development
- Anomalies in central or peripheral nervous system development
AI-Screening
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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
CONTACT
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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