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

February 3, 2025 updated by: Skolkovo Institute of Science and Technology
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Visual analogue scale (VAS)
Time Frame: Up to 4 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory threshold
Time Frame: Up to 6 months
In this experiment, the goal is to determine the minimum stimulation amplitude that elicits a sensory response. Participants are stimulated by PMS on different power levels and describe their sensations. PMS of the median nerve should evoke tactile response without the muscle response in the area of the palm and fingers which are innervated by it. Sensory threshold is the minimum intensity level which evokes sensory sensations in this particular area.
Up to 6 months
Sensory mapping
Time Frame: Up to 4 months
Participants mark their sensations evoked by PMS using PerceptMapper on the scale from 0 (no sensation) to 10 (uncomfortably intense). Participants also mark sensation location on a hand image, describe the sensation's naturalness and intensity and some characteristics of these sensations (tingling, temperature change, et.c.).
Up to 4 months
Pain detect
Time Frame: Up to 1 year
The questionnaire combines a pain distribution diagram with a visual analog scale (VAS) and a section focused on identifying spontaneous and triggered neuropathic pain symptoms. It also assesses the nature of pain using the diagram, categorizing it as constant, episodic, or constant with episodes, among others. The questionnaire comprehensively reflects all possible pain parameters, allowing for clear tracking of pain dynamics over time. Its diagnostic accuracy is 83%.
Up to 1 year
DN4
Time Frame: Up to 1 year
The DN4 (Douleur Neuropathique 4) questionnaire is a diagnostic tool designed to identify neuropathic pain, caused by nerve damage. It includes 10 items divided into two sections. The first part consists of seven questions that assess the patient's pain symptoms, such as burning, tingling, electric shocks, or numbness. The second part involves a clinical examination where the physician tests for reduced sensitivity to touch and pinprick, as well as pain response to light brushing. Each item is scored with 1 point for "Yes" and 0 for "No." A total score of 4 or higher indicates a high probability of neuropathic pain.
Up to 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social-demographic questionnaire
Time Frame: Up to 1 year
Participants fill in the form about their background in their professional sphere and their experience as sportsmen and musicians. This measure can help determine the possible connections between the background and the individual results and enhance personalized care, ultimately leading to better patient outcomes and satisfaction.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skolkovo Institute of Science and Technology

Collaborators

Motorica LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2024

Primary Completion (Estimated)

September 16, 2027

Study Completion (Estimated)

September 16, 2027

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Skoltech-CNBR6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe