Actively Recruiting
Evaluation of Neuroprosthesis with Sensory Feedback for Modulation of Phantom Limb Pain and Enhancing Quality of Life
Led by Skolkovo Institute of Science and Technology · Updated on 2024-11-25
50
Participants Needed
2
Research Sites
230 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 clinical trial is designed to assess the effectiveness of advanced neuromodulation techniques in reducing phantom limb pain by improving sensory feedback in bionic prostheses. The study will explore the use of Peripheral Nerve Stimulation to evaluate their impact on pain relief and sensory restoration. The trial aims the development of neuroprostheses that can provide sensory feedback through stimulation.
CONDITIONS
Official Title
Evaluation of Neuroprosthesis with Sensory Feedback for Modulation of Phantom Limb Pain and Enhancing Quality of Life
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Amputation of the upper limb at the forearm or upper arm level, or of the lower limb at the lower leg or thigh level
- Age between 18 and 65 years
- At least 6 months since the amputation
- Persistent chronic pain syndrome rated 4 to 10 on the Visual Analog Scale (VAS)
- No pregnancy at the time of implantation (for females), confirmed by pregnancy test
- Signed consent to participate in the study
You will not qualify if you...
- Severe somatic pathology that prevents surgery and study participation
- Psychiatric disorders, including history of severe depression, suicidal tendencies, or suicide attempts
- Severe orthopedic deformity in the limb above the amputation level
- History of cancer
- History of epilepsy
- Complicated traumatic brain injury (TBI) or history of stroke
- Inability to undergo electrostimulation due to somatic pathology
- Purulent-septic pathology
- Drug addiction, including history
- Congenital anomaly of upper limb development
- Anomalies in central and 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, Russia, 117997
Actively Recruiting
2
Far Eastern Federal University
Moscow, Russia, 690922
Actively Recruiting
Research Team
Y
Yury Matvienko
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
8
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