Peripheral Magnetic Stimulation (PMS) Effects on Somatosensory Perception in Patients with Upper Limb Amputation

Skolkovo Institute of Science and Technology

Status: Enrolling

Conditions: Phantom Limb Pain

Treatments: Other: Electroencephalography (EEG); Device: Procedure: Peripheral Magnetic Stimulation (PMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06813937

Skoltech-CNBR6

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)