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

Last updated: February 3, 2025
Sponsor: Skolkovo Institute of Science and Technology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Treatment

Procedure: Peripheral Magnetic Stimulation (PMS)

Electroencephalography (EEG)

Clinical Study ID

NCT06813937
Skoltech-CNBR6
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion

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. InclusionCriteria

Exclusion

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.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Procedure: Peripheral Magnetic Stimulation (PMS)
Phase:
Study Start date:
September 16, 2024
Estimated Completion Date:
September 16, 2027

Connect with a study center

  • Skolkovo Institute of Science and Technology (Skoltech)

    Moscow,
    Russian Federation

    Active - Recruiting

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