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
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 evaluating advanced neuromodulation techniques to reduce phantom limb pain by enhancing sensory feedback in bionic prostheses. This trial focuses on Peripheral Nerve Stimulation and other stimulation methods to assess their effect on pain relief and sensory restoration. The goal is to develop neuroprostheses that provide sensory feedback to improve quality of life for people with limb amputations. The study involves several neuromodulation procedures including Peripheral Nerve Stimulation, Spinal Cord Stimulation, Dorsal Root Ganglion Stimulation, and Motor Cortex Stimulation. Each procedure involves implanting electrodes near targeted nerves or brain areas using imaging guidance and local anesthesia. Participants receive stimulation through these implanted devices to evaluate their impact on phantom limb pain. Participants will be monitored for up to six months with repeated assessments including pain scales (VAS, DN4), quality of life questionnaires (SF-36), sensory threshold measurements, and psychological evaluations (Hospital Anxiety and Depression Scale). Researchers will track changes in pain, sensory perception, embodiment, and emotional state. The total participation includes preoperative evaluation, implantation, and follow-up visits to assess outcomes and safety of the neurostimulation treatments.
CONDITIONS
Brief 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 lower limb at the lower leg or thigh level
- 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 females), confirmed by pregnancy test
- Signed consent to participate in the study
You will not qualify if you...
- Severe somatic conditions preventing surgery or study participation
- Psychiatric disorders including history of severe depression or suicidal tendencies
- Severe orthopedic deformity above amputation level
- History of cancer or epilepsy
- Complicated traumatic brain injury or stroke history
- Inability to undergo electrostimulation due to other somatic pathology
- Presence of purulent-septic infections
- History of drug addiction
- Congenital upper limb development anomalies
- Abnormalities 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 - Up to 6 months
Participants undergo implantation of neuroprosthetic devices such as peripheral nerve stimulation, spinal cord stimulation, dorsal root ganglion stimulation, or motor cortex stimulation to modulate phantom limb pain and enhance quality of life.
At least 3 visits within the first 5 months for sensory threshold assessments and additional visits for ongoing device management and assessments
Duration - Up to 6 months
Participants are monitored for pain levels, sensory changes, and quality of life outcomes after neuroprosthesis implantation.
Regular visits for outcome assessments including pain scales and psychological measures up to 6 months
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
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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