NCT06813937

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
17mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Sep 2024Sep 2027

Study Start

First participant enrolled

September 16, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2027

Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

February 3, 2025

Last Update Submit

February 3, 2025

Conditions

Phantom Limb Pain

Keywords

NeuromodulationPhantom limb painNeuropathic painNeurostimulationChronic painPeripheral magnetic stimulationPMSAmputationAmputees

Outcome Measures

Primary Outcomes (1)

  • 1. Visual analogue scale (VAS)

    The Visual Analog Scale (VAS) is a 10 cm line used to measure pain intensity. One end of the line represents no pain; while the other end signifies worst possible pain"; The line can be either horizontal or vertical.

    Up to 4 months

Secondary Outcomes (4)

  • Sensory threshold

    Up to 6 months

  • Sensory mapping

    Up to 4 months

  • Pain detect

    Up to 1 year

  • DN4

    Up to 1 year

Other Outcomes (1)

  • Social-demographic questionnaire

    Up to 1 year

Interventions

Procedure: Peripheral Magnetic Stimulation (PMS)DEVICE

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.

Electroencephalography (EEG)OTHER

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Availability of signed written informed consent.

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skolkovo Institute of Science and Technology (Skoltech)

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Phantom LimbNeuralgiaChronic Pain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPain, PostoperativePostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsPainPeripheral Nervous System DiseasesNeuromuscular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2025

First Posted

February 7, 2025

Study Start

September 16, 2024

Primary Completion (Estimated)

September 16, 2027

Study Completion (Estimated)

September 16, 2027

Last Updated

February 7, 2025

Record last verified: 2025-02

Locations

RU(1)