Phantom Limb PainNCT06813937
Peripheral Magnetic Stimulation (PMS) Effects on Somatosensory Perception in Patients with Upper Limb Amputation
A study testing Procedure: Peripheral Magnetic Stimulation (PMS) and Electroencephalography (EEG) in people with Phantom Limb Pain, run by Skolkovo Institute of Science and Technology at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- Procedure: Peripheral Magnetic Stimulation (PMS) and Electroencephalography (EEG)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 16 Sep 2024to 16 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Skolkovo Institute of Science and Technology (Skoltech)
Moscow
Daria Petrova, PhD, d.petrova@skoltech.ru
About this study
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
- Being tested
- Procedure: Peripheral Magnetic Stimulation (PMS), Electroencephalography (EEG)
- Keywords
- Neuromodulation, Phantom limb pain, Neuropathic pain, Neurostimulation, Chronic pain, Peripheral magnetic stimulation, PMS, Amputation, Amputees
- Medical subject headings
- Phantom Limb, Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 months
Secondary outcomes (4)
Sensory threshold
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.
Measured: Up to 6 months
Sensory mapping
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.).
Measured: Up to 4 months
Pain detect
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%.
Measured: Up to 1 year
DN4
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start16 Sep 2024
- Primary completion16 Sep 2027 (estimated)
- Study completion16 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skolkovo Institute of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Motorica LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813937
- Sponsor's protocol ID
- Skoltech-CNBR6
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Magnetic Stimulation (PMS) Effects on Somatosensory Perception in Patients with Upper Limb Amputation
- ClinicalTrials.gov ID
- NCT06813937
- Acronym / sponsor ID
- Skoltech-CNBR6
- Conditions
- Phantom Limb Pain
- Keywords
- Neuromodulation, Phantom limb pain, Neuropathic pain, Neurostimulation, Chronic pain, Peripheral magnetic stimulation, PMS, Amputation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Skolkovo Institute of Science and TechnologyUniversity, hospital or other
- Collaborators
- Motorica LLC
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 16 Sep 2027 (estimated)
- Study completion
- 16 Sep 2027 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | 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. | Other | – |
Primary outcome
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.
4 secondary outcomes
Sensory threshold
Time frame: Up to 6 months
Sensory mapping
Time frame: Up to 4 months
Pain detect
Time frame: Up to 1 year
DN4
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: Peripheral Magnetic Stimulation (PMS) and Electroencephalography (EEG) in people with Phantom Limb Pain, run by Skolkovo Institute of Science and Technology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Visual analogue scale (VAS) (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.