Phantom Limb PainNCT06644807
Study of Phantom Limb Pain Suppression Using Neuromodulation Methods
A study testing Motor Cortex Stimulation, Spinal cord stimulation and Peripheral Nerve Stimulation in people with Phantom Limb Pain, run by Skolkovo Institute of Science and Technology at 2 sites in Russia.
Trial summary
This study assesses the effectiveness of neuromodulation in alleviating pain through the stimulation of peripheral nerves. The research involves implanting electrodes for test stimulation of peripheral nerves (PNS - Peripheral Nerve Stimulation), spinal cord (SCS - Spinal Cord Stimulation), dorsal root ganglia (DRGS … Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- Motor Cortex Stimulation, Spinal cord stimulation and Peripheral Nerve Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Sep 2024to 1 May 2029
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Amputation of the upper limb at the level of the forearm or upper arm, or amputation of the lower limb at the level of the lower leg or thigh.
- Age between 18 and 65 years.
- Duration since amputation is at least 6 months.
- Presence of persistent chronic pain syndrome rated between 4 and 10 on the Visual Analog Scale (VAS).
- Absence of pregnancy at the time of implantation, confirmed by a pregnancy test (for female participants only).
- Signed consent to participate in the study.
Who cannot join
- Presence of severe somatic pathology that hinders surgical treatment and participation in the study.
- Presence of psychiatric disorders (including a history of), severe depression, suicidal tendencies, or a history of suicide attempts.
- Presence of severe orthopedic deformity in the limb above the level of amputation.
- History of cancer.
- History of epilepsy.
- Complicated traumatic brain injury (TBI) or a history of stroke.
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- Inability to undergo electrostimulation due to other somatic pathology.
- Purulent-septic pathology.
- Drug addiction (including a history of).
- Congenital anomaly of upper limb development.
- Anomalies in the development of the central and peripheral nervous systems.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia2 sites, 2 recruiting
- Recruiting
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia
Moscow, Moscow, 117997
Artur Biktimirov, MD, +79149651488, biartur2006@yandex.ru
- Recruiting
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia
Moscow, 117997
About this study
Official title: Neuromodulation Methods for Suppressing Phantom Limb Pain
This study assesses the effectiveness of neuromodulation in alleviating pain through the stimulation of peripheral nerves. The research involves implanting electrodes for test stimulation of peripheral nerves (PNS - Peripheral Nerve Stimulation), spinal cord (SCS - Spinal Cord Stimulation), dorsal root ganglia (DRGS - Dorsal Root Ganglion Stimulation), and motor cortex (MCS - Motor Cortex Stimulation). The study aims to explore the use of neuromodulation for pain relief in patients experiencing pain due to upper or lower limb amputation.
- Conditions
- Phantom Limb Pain
- Being tested
- Motor Cortex Stimulation, Spinal cord stimulation, Peripheral Nerve Stimulation, Dorsal Root Ganglion Stimulation
- Keywords
- Neuromodulation, Phantom limb pain, Neuropathic pain, Neurostimulation, Chronic pain, Peripheral nerve stimulation, PNS, Spinal cord stimulation, SCS, Dorsal root ganglion stimulation, DRG, Cortical stimulation, Amputation, Amputees, Upper-limb injury
- Medical subject headings
- Phantom Limb, Neuralgia, Chronic Pain, Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Cortex StimulationProcedure or surgery
Motor Cortex Stimulation (MCS) is a neuromodulation technique that involves the surgical implantation of electrodes over the motor cortex, typically targeting the precentral gyrus, to deliver electrical stimulation. The procedure involves placing an electrode grid or strip on the dura mater overlying the motor cortex, which is identified via neuroimaging techniques such as functional MRI or neuronavigation. Once implanted, the electrodes are connected to an implanted pulse generator (IPG), which delivers adjustable electrical impulses.
Spinal cord stimulationProcedure or surgery
Spinal Cord Stimulation (SCS) is a neuromodulation that involves the implantation of a device that delivers electrical impulses to the spinal cord through an electrode placed in the epidural space. The stimulation alters pain signals before they reach the brain, effectively masking or reducing the sensation of pain.
Peripheral Nerve StimulationProcedure or surgery
Peripheral Nerve Stimulation (PNS) is a neuromodulation technique used to treat chronic pain. The procedure starts with a preoperative assessment, including imaging to identify the target peripheral nerve. Under local anesthesia, a thin, insulated electrode is implanted near the nerve, usually with the help of fluoroscopic or ultrasound guidance for precision.
Dorsal Root Ganglion StimulationProcedure or surgery
Dorsal Root Ganglion Stimulation (DRGS) is a targeted neuromodulation technique for managing chronic pain. The procedure begins with a thorough preoperative assessment, including imaging to locate the specific dorsal root ganglion (DRG) associated with the pain. Under local anesthesia, a small electrode is implanted near the DRG. This is done through a minimally invasive procedure, often guided by fluoroscopy or CT imaging to ensure precise placement.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral nerve stimulation | Experimental | Not described Receives: Procedure: Peripheral Nerve Stimulation |
| Spinal cord stimulation | Experimental | Not described Receives: Procedure: Spinal cord stimulation |
| Motor Cortex Stimulation | Experimental | Not described Receives: Procedure: Motor Cortex Stimulation |
| Dorsal Root Ganglion Stimulation | Experimental | Not described Receives: Procedure: Dorsal Root Ganglion Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
SF-36
The questionnaire consists of 36 items grouped into eight scales: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health. Each scale ranges from 0 to 100, where 100 represents full health. Higher scores indicate better quality of life, with two summary measures: physical and mental well-being.
Measured: up to 1 year
Secondary outcomes (5)
Sensory mapping
The sensory mapping procedure involved evoking sensations in phantom hands through peripheral nerve stimulation (PNS). Electrode pairs were selected, and stimulation parameters, with fixed pulse width and frequency were applied. Stimulation amplitude was gradually increased in 0.1-mA steps until participants rated their sensation intensity from 0 (no sensation) to 10 (uncomfortably intense). Upon reaching a score of 5, participants marked sensation location on a hand image and described the sensation's naturalness and intensity.
Measured: up to 4 months
Pain detect
The questionnaire is intended for completion by a physician and 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 1 year
DN 4
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
Hospital Anxiety and Depression Scale, HADS
The Hospital Anxiety and Depression Scale (HADS) is a widely used screening tool designed to assess anxiety and depression levels in patients in non-psychiatric hospital settings. It consists of 14 items, divided into two subscales: seven questions assess anxiety (HADS-A) and seven assess depression (HADS-D). The items focus on emotional and cognitive symptoms rather than physical symptoms, making it suitable for patients with medical conditions. Each item is scored on a scale of 0 to 3, with total scores for each subscale ranging from 0 to 21. A score of 8 or more on either subscale suggests the presence of anxiety or depression. The HADS is valued for its simplicity and reliability in clinical and research settings.
Measured: up to 1 year
Sensory threshold
In this experiment, the goal is to determine the minimum stimulation amplitude that elicits a sensory response. Participants are shown the numbers 1 and 2 on a screen, with stimulation activated simultaneously upon the appearance of one of the numbers. Their task is to identify when the stimulation occurred and input their answer on a keyboard. An expanded version of the experiment may provide stimulation during both moments, requiring participants to determine which moment had a higher stimulation level. The results will yield a psychophysical curve that illustrates the relationship between response accuracy and stimulation amplitude, as well as the participants' ability to differentiate stimulation parameters. It is anticipated that over time, the sensory threshold will shift, leading to increased accuracy in parameter identification.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Sep 2024
- Primary completion1 Sep 2028 (estimated)
- Study completion1 May 2029 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skolkovo Institute of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Motorica LLC, Federal center of brain research and neurotechnologies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644807
- Sponsor's protocol ID
- Skoltech-CNBR4
- Status last verified
- Oct 2024
- First submitted
- 2 Sep 2024
- Last updated
- 16 Oct 2024
- 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 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation Methods for Suppressing Phantom Limb Pain
- ClinicalTrials.gov ID
- NCT06644807
- Acronym / sponsor ID
- Skoltech-CNBR4
- Conditions
- Phantom Limb Pain
- Keywords
- Neuromodulation, Phantom limb pain, Neuropathic pain, Neurostimulation, Chronic pain, Peripheral nerve stimulation, PNS, Spinal cord stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Skolkovo Institute of Science and TechnologyUniversity, hospital or other
- Collaborators
- Motorica LLC, Federal center of brain research and neurotechnologies
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 16 Oct 2024 (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.
This study assesses the effectiveness of neuromodulation in alleviating pain through the stimulation of peripheral nerves. The research involves implanting electrodes for test stimulation of peripheral nerves (PNS - Peripheral Nerve Stimulation), spinal cord (SCS - Spinal Cord Stimulation), dorsal root ganglia (DRGS - Dorsal Root Ganglion Stimulation), and motor cortex (MCS - Motor Cortex Stimulation). The study aims to explore the use of neuromodulation for pain relief in patients experiencing pain due to upper or lower limb amputation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Peripheral nerve stimulation | Experimental | Procedure: Peripheral Nerve Stimulation |
| Spinal cord stimulation | Experimental | Procedure: Spinal cord stimulation |
| Motor Cortex Stimulation | Experimental | Procedure: Motor Cortex Stimulation |
| Dorsal Root Ganglion Stimulation | Experimental | Procedure: Dorsal Root Ganglion Stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Amputation of the upper limb at the level of the forearm or upper arm, or amputation of the lower limb at the level of the lower leg or thigh.
- Age between 18 and 65 years.
- Duration since amputation is at least 6 months.
- Presence of persistent chronic pain syndrome rated between 4 and 10 on the Visual Analog Scale (VAS).
- Absence of pregnancy at the time of implantation, confirmed by a pregnancy test (for female participants only).
Key exclusion criteria (11 listed)
- Presence of severe somatic pathology that hinders surgical treatment and participation in the study.
- Presence of psychiatric disorders (including a history of), severe depression, suicidal tendencies, or a history of suicide attempts.
- Presence of severe orthopedic deformity in the limb above the level of amputation.
- History of cancer.
- History of epilepsy.
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 |
|---|---|---|
| Motor Cortex StimulationMotor Cortex Stimulation (MCS) is a neuromodulation technique that involves the surgical implantation of electrodes over the motor cortex, typically targeting the precentral gyrus, to deliver electrical stimulation. The procedure involves placing an electrode grid or strip on the dura mater overlying the motor cortex, which is identified via neuroimaging techniques such as functional MRI or neuronavigation. Once implanted, the electrodes are connected to an implanted pulse generator (IPG), which delivers adjustable electrical impulses. | Procedure or surgery | Motor Cortex Stimulation |
| Spinal cord stimulationSpinal Cord Stimulation (SCS) is a neuromodulation that involves the implantation of a device that delivers electrical impulses to the spinal cord through an electrode placed in the epidural space. The stimulation alters pain signals before they reach the brain, effectively masking or reducing the sensation of pain. | Procedure or surgery | Spinal cord stimulation |
| Peripheral Nerve StimulationPeripheral Nerve Stimulation (PNS) is a neuromodulation technique used to treat chronic pain. The procedure starts with a preoperative assessment, including imaging to identify the target peripheral nerve. Under local anesthesia, a thin, insulated electrode is implanted near the nerve, usually with the help of fluoroscopic or ultrasound guidance for precision. | Procedure or surgery | Peripheral nerve stimulation |
| Dorsal Root Ganglion StimulationDorsal Root Ganglion Stimulation (DRGS) is a targeted neuromodulation technique for managing chronic pain. The procedure begins with a thorough preoperative assessment, including imaging to locate the specific dorsal root ganglion (DRG) associated with the pain. Under local anesthesia, a small electrode is implanted near the DRG. This is done through a minimally invasive procedure, often guided by fluoroscopy or CT imaging to ensure precise placement. | Procedure or surgery | Dorsal Root Ganglion Stimulation |
Primary outcome
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.
SF-36
Time frame: up to 1 year
The questionnaire consists of 36 items grouped into eight scales: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health. Each scale ranges from 0 to 100, where 100 represents full health. Higher scores indicate better quality of life, with two summary measures: physical and mental well-being.
5 secondary outcomes
Sensory mapping
Time frame: up to 4 months
Pain detect
Time frame: Up 1 year
DN 4
Time frame: up to 1 year
Hospital Anxiety and Depression Scale, HADS
Time frame: up to 1 year
Sensory threshold
Time frame: up to 6 months
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 16 Oct 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Cortex Stimulation, Spinal cord stimulation and Peripheral Nerve Stimulation in people with Phantom Limb Pain, run by Skolkovo Institute of Science and Technology at 2 sites 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 6 inclusion and 11 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Yury Matveenko (+79163843070, medtream@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (time frame: Up to 4 months). The study lists 2 primary outcomes in all. 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 16 Oct 2024.