Clinical trial NCT06813937: Peripheral Magnetic Stimulation (PMS) Effects on Somatosensory Perception in Patients with Upper Limb Amputation
Official title: Peripheral Magnetic Stimulation (PMS) Effects on Somatosensory Perception in Patients with Upper Limb Amputation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Phantom Limb Pain
Keywords: Neuromodulation
Phantom limb pain
Neuropathic pain
Neurostimulation
Chronic pain
Peripheral magnetic stimulation
PMS
Amputation
Amputees
Lead sponsor: Skolkovo Institute of Science and Technology
Sponsor class: OTHER
Collaborators: name: Motorica LLC
First posted: 2025-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study investigates the capabilities of peripheral magnetic stimulation (PMS) as a tool for creating somatosensory sensations of various submodalities and analyzing the dynamics of bioelectric signals of the brain (using encephalography (EEG)) in healthy participants and participants with upper limb amputations. During the experiment, the participants' subjective sensations and EEG activity are recorded in response to magnetic pulses of varying intensity. In addition, the continuous PMS stimulation protocol and its effect on phantom sensations in participants with amputations will be tested for subsequent implementation in clinical practice.


Eligibility criteria: For Healthy Volunteers:

Inclusion Criteria:

1. Availability of signed written informed consent.
2. Absence of somatic and psychiatric diseases (more details in the exclusion criteria)
3. Ability and willingness to comply with the requirements of this protocol. Inclusion Criteria

Exclusion Criteria:

1. History of epilepsy (participant, participant's close relatives)
2. Presence of metal or/and electric stimulators and/or implants in participant's body
3. Presence of psychiatric disorders (including a history of), severe depression, suicidal tendencies, or a history of suicide attempts.
4. History of cancer.
5. Complicated traumatic brain injury (TBI) or a history of stroke.
6. Drug addiction (including a history of).
7. Congenital anomaly of upper limb development.
8. Anomalies in the development of the central and peripheral nervous systems.
9. Pregnancy

For stroke patients:

1. History of epilepsy (participant, participant's close relatives)
2. Presence of metal or/and electric stimulators and/or implants in participant's body
3. Presence of psychiatric disorders (including a history of), severe depression, suicidal tendencies, or a history of suicide attempts.
4. History of cancer.
5. Complicated traumatic brain injury (TBI) or a history of stroke.
6. Drug addiction (including a history of).
7. Congenital anomaly of upper limb development.
8. Anomalies in the development of the central and peripheral nervous systems.
9. Pregnancy
10. Presence of severe somatic pathology
11. Presence of severe orthopedic deformity in the limb above the level of amputation.
12. Purulent-septic pathology.

Primary outcomes:
measure: 1. Visual analogue scale (VAS)
timeFrame: Up to 4 months
Secondary outcomes:
measure: Sensory threshold
timeFrame: Up to 6 months
measure: Sensory mapping
timeFrame: Up to 4 months
measure: Pain detect
timeFrame: Up to 1 year
measure: DN4
timeFrame: Up to 1 year
Other outcomes:
measure: Social-demographic questionnaire
timeFrame: Up to 1 year
Locations:
city: Moscow
country: Russian Federation
facility: Skolkovo Institute of Science and Technology (Skoltech)
Study officials:
References: