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

Обзор

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.

Вмешательства

• Устройство Procedure: 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.
• Другое Electroencephalography (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.

Первичные конечные точки

• 1. Visual analogue scale (VAS) [Срок оценки: Up to 4 months]

Вторичные конечные точки (4)

• Sensory threshold [Срок оценки: Up to 6 months]
• Sensory mapping [Срок оценки: Up to 4 months]
• Pain detect [Срок оценки: Up to 1 year]
• DN4 [Срок оценки: Up to 1 year]

Критерии участия

For Healthy Volunteers:

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Россия · 1 центр

• Skolkovo Institute of Science and Technology (Skoltech) — Moscow

Идентификаторы

NCT: NCT06813937 · Skoltech-CNBR6

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗