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

NCT ID: NCT06813937

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-16
• Study Completion Date: 2027-09-16

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.

Conditions

Phantom Limb Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Availability of signed written informed consent.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Motorica LLC

UNKNOWN

Sponsor Role: collaborator

Skolkovo Institute of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Skolkovo Institute of Science and Technology (Skoltech)

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Facility Contacts

Daria Petrova, PhD

Role: primary

d.petrova@skoltech.ru

Other Identifiers

Skoltech-CNBR6

Identifier Type: -

Identifier Source: org_study_id