Effects of magnetic stimulation on phantom limb pain in amputees

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

This study tests if using magnetic stimulation can help reduce phantom limb pain in people who have had upper limb amputations.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Skolkovo Institute of Science and Technology (Academic / other)
• Locations: 1 site (Moscow)
• Trial ID: NCT06813937 on ClinicalTrials.gov

What this trial studies

This study investigates the use of peripheral magnetic stimulation (PMS) to create somatosensory sensations and analyze brain bioelectric signals in both healthy individuals and those with upper limb amputations. Participants will undergo PMS with varying magnetic pulse intensities while their subjective sensations and EEG activity are recorded. The study aims to evaluate the continuous PMS stimulation protocol's effects on phantom sensations, with the goal of future clinical application.

Who should consider this trial

Good fit: Ideal candidates include individuals with upper limb amputations experiencing phantom limb pain.

Not a fit: Patients with psychiatric disorders, a history of epilepsy, or those with metal implants may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly alleviate phantom limb pain for amputees.

How similar studies have performed: While the use of neuromodulation techniques has shown promise in related studies, the specific application of PMS for phantom limb pain is relatively novel.

Eligibility 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.

Where this trial is running

Moscow

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

Conditions Phantom Limb Pain; Neuromodulation; Phantom limb pain; Neuropathic pain; Neurostimulation; Chronic pain; Peripheral magnetic stimulation; PMS