Actively Recruiting
Peripheral Magnetic Stimulation (PMS) Effects on Somatosensory Perception in Patients with Upper Limb Amputation
Led by Skolkovo Institute of Science and Technology · Updated on 2025-02-07
30
Participants Needed
1
Research Sites
N/A
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
The trial investigates the use of peripheral magnetic stimulation (PMS) to create different types of somatosensory sensations and analyze brain activity through encephalography (EEG) in healthy individuals and people with upper limb amputations. It aims to understand how PMS affects nerve signals and phantom limb sensations, which could help develop new clinical treatments for amputees. The study is sponsored by the Skolkovo Institute of Science and Technology and includes participants aged 18 to 65 years. During the study, participants undergo sensory mapping and hotspot localization to determine sensory thresholds. They then receive two PMS protocols: five blocks of stimulation at varying frequencies and one block of repetitive PMS (rPMS). EEG electrodes placed on the scalp record brain activity at the same time as PMS is applied. This non-invasive procedure monitors responses to magnetic pulses to assess sensory perception and phantom sensations. Participants will provide feedback on their sensations and undergo EEG recordings during the PMS sessions. Researchers will measure outcomes such as pain levels using a visual analogue scale (VAS) over four months, sensory threshold and mapping up to six months, and pain detection assessments up to one year. The study includes healthy volunteers and patients with phantom limb pain. Safety monitoring and follow-up extend up to one year after treatment.
CONDITIONS
Brief Title
Peripheral Magnetic Stimulation (PMS) Effects on Somatosensory Perception in Patients with Upper Limb Amputation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent is required.
- Participants must have no somatic or psychiatric diseases.
- Ability and willingness to follow the study protocol requirements.
- Age between 18 and 65 years.
- Includes healthy volunteers and participants with upper limb amputations experiencing phantom limb pain.
You will not qualify if you...
- History of epilepsy in participant or close relatives.
- Presence of metal or electrical stimulators or implants in the body.
- Presence or history of psychiatric disorders, severe depression, suicidal tendencies, or suicide attempts.
- History of cancer.
- Complicated traumatic brain injury or history of stroke.
- Drug addiction or history of drug addiction.
- Congenital anomalies in upper limb development.
- Anomalies in central or peripheral nervous system development.
- Pregnancy.
- Severe somatic pathology (for stroke patients).
- Severe orthopedic deformity above the amputation level.
- Purulent-septic pathology.
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 - Single session
Participants receive Peripheral Magnetic Stimulation (PMS), a non-invasive neuromodulation technique, which includes sensory mapping, hotspot localisation, sensory threshold detection, and application of two PMS protocols. Electroencephalography (EEG) recordings are made simultaneously with PMS.
1 visit (in-person)
Duration - Up to 1 year
Participants are monitored for changes in pain and sensory perception using assessments such as Visual Analogue Scale (VAS), sensory threshold, sensory mapping, Pain Detect, and DN4 up to one year after the intervention.
Periodic visits for assessments depending on the schedule
Trial Site Locations
Total: 1 location
1
Skolkovo Institute of Science and Technology (Skoltech)
Moscow, Russia
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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