RecruitingNot ApplicableNCT06813937

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


Sponsor

Skolkovo Institute of Science and Technology

Enrollment

30 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

  • For Healthy Volunteers:
  • Availability of signed written informed consent.

Exclusion Criteria22

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

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Interventions

DEVICEProcedure: Peripheral Magnetic Stimulation (PMS)

PMS is a non-invasive neuromodulation technique used to treat chronic pain. Procedure starts with sensory mapping, localisation of the hotspot and detection of sensory threshold. Then two protocols of PMS are implemented: 5 blocks of PMS of varying frequency and 1 block of rPMS.

OTHERElectroencephalography (EEG)

EEG is a technique commonly used for the registration of brain activity. The procedure is non-invasive, electrodes are placed on the scalp of the participants. The recording is made simultaneously with the PMS.


Locations(1)

Skolkovo Institute of Science and Technology (Skoltech)

Moscow, Russia

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NCT06813937