Phantom Limb PainNCT06702904
Evaluation of Neuroprosthesis with Sensory Feedback for Modulation of Phantom Limb Pain and Enhancing Quality of Life
A study testing Peripheral Nerve Stimulation, Spinal cord stimulation and Dorsal Root Ganglion Stimulation in people with Phantom Limb Pain, run by Skolkovo Institute of Science and Technology at 2 sites in Russia.
Trial summary
This clinical trial is designed to assess the effectiveness of advanced neuromodulation techniques in reducing phantom limb pain by improving sensory feedback in bionic prostheses. The study will explore the use of Peripheral Nerve Stimulation to evaluate their impact on pain relief and sensory restoration. 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?
- Peripheral Nerve Stimulation, Spinal cord stimulation and Dorsal Root Ganglion 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 Dec 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, 117997
Artur Biktimirov, MD, +79149651488, biartur2006@yandex.ru
- Recruiting
Far Eastern Federal University
Moscow, 690922
Artur Biktimirov, MD, +79149651488, biartur2006@yandex.ru
About this study
This clinical trial is designed to assess the effectiveness of advanced neuromodulation techniques in reducing phantom limb pain by improving sensory feedback in bionic prostheses. The study will explore the use of Peripheral Nerve Stimulation to evaluate their impact on pain relief and sensory restoration. The trial aims the development of neuroprostheses that can provide sensory feedback through stimulation.
- Conditions
- Phantom Limb Pain
- Being tested
- Peripheral Nerve Stimulation, Spinal cord stimulation, Dorsal Root Ganglion Stimulation, Motor Cortex 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, Neurotechnology, Neuroprosthetics, BCI
- 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.
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.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral nerve stimulation for upper-limb prosthesis | Experimental | Not described Receives: Procedure: Peripheral Nerve Stimulation |
| Peripheral nerve stimulation for lower-limb prosthesis | Experimental | Not described Receives: Procedure: Peripheral Nerve Stimulation |
| Spinal cord stimulation for upper-limb prosthesis | Experimental | Not described Receives: Procedure: Spinal cord stimulation |
| Spinal cord stimulation for lower-limb prosthesis | Experimental | Not described Receives: Procedure: Spinal cord stimulation |
| Dorsal root ganglion stimulation for upper-limb prosthesis | Experimental | Not described Receives: Procedure: Dorsal Root Ganglion Stimulation |
| Experimental: Dorsal root ganglion stimulation for lower-limb prosthesis | Experimental | Not described Receives: Procedure: Dorsal Root Ganglion Stimulation |
| Motor Cortex Stimulation for upper-limb prosthesis | Experimental | Not described Receives: Procedure: Motor Cortex Stimulation |
| Motor Cortex Stimulation for lower-limb prosthesis | Experimental | Not described Receives: Procedure: Motor Cortex Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 months
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 6 months
Secondary outcomes (6)
Sensory threshold change
In this task, the minimal amplitude of stimulation required to evoke a sensory response is experimentally determined. Numbers 1 and 2 appear on the screen, and at the moment one of the numbers appears, stimulation is simultaneously activated. The participant's task is to identify when the stimulation occurred and to input their response using the keyboard. After completing the task, a psychophysical curve will be computed, and the amplitude value that yields an accuracy of 0.75 will be used.
Measured: At least three measurements. 1 - First week after implantation, 2 - Up to three months after implantation, 3 - Up to five months after implantation
Agency
Self-report questionnaires where participants rate their sense of agency over the prosthesis during tasks. It uses 0 to 10 scale, where 0 means lower agency and 10 means higher agency
Measured: Up to 6 months
Embodiment
Throughout the study, participants will be asked to complete questionnaires assessing the degree of embodiment of the prosthesis. Since during the experimental sessions, feedback from the prosthesis is projected onto the phantom limb, the research team anticipates observing a transfer effect from the phantom limb to the robotic hand. The degree of this transfer will be evaluated using the Embodiment questionnaires for both upper and lower limbs.
Embodiment uses scale from -9 to 9; -9 means "No embodiment" and 9 means "High embodiment".
Measured: Up to 6 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.
The total score ranges from -1 to 38. Based on this score:
≤ 12: Neuropathic pain is unlikely. 13-18: The result is ambiguous; further assessment may be needed.
≥ 19: Neuropathic pain is likely.
Measured: Up to 6 months
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 6 months
Ownership
Self-report questionnaires where participants rate their sense of ownership over the prosthesis during tasks. It uses 0 to 10 scale, where 0 means lower agency and 10 means higher agency
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 posted25 Nov 2024
- Study start1 Dec 2024 (estimated)
- 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
- Supportive care
- 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, The Federal Center of Brain Research and Neurotechnologies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702904
- Sponsor's protocol ID
- Skoltech-CNBR5
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 25 Nov 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 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neuroprosthesis with Sensory Feedback for Modulation of Phantom Limb Pain and Enhancing Quality of Life
- ClinicalTrials.gov ID
- NCT06702904
- Acronym / sponsor ID
- Skoltech-CNBR5
- 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, The Federal Center of Brain Research and Neurotechnologies
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 25 Nov 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 clinical trial is designed to assess the effectiveness of advanced neuromodulation techniques in reducing phantom limb pain by improving sensory feedback in bionic prostheses. The study will explore the use of Peripheral Nerve Stimulation to evaluate their impact on pain relief and sensory restoration. The trial aims the development of neuroprostheses that can provide sensory feedback through stimulation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Peripheral nerve stimulation for upper-limb prosthesis | Experimental | Procedure: Peripheral Nerve Stimulation |
| Peripheral nerve stimulation for lower-limb prosthesis | Experimental | Procedure: Peripheral Nerve Stimulation |
| Spinal cord stimulation for upper-limb prosthesis | Experimental | Procedure: Spinal cord stimulation |
| Spinal cord stimulation for lower-limb prosthesis | Experimental | Procedure: Spinal cord stimulation |
| Dorsal root ganglion stimulation for upper-limb prosthesis | Experimental | Procedure: Dorsal Root Ganglion Stimulation |
| Experimental: Dorsal root ganglion stimulation for lower-limb prosthesis | Experimental | Procedure: Dorsal Root Ganglion Stimulation |
| Motor Cortex Stimulation for upper-limb prosthesis | Experimental | Procedure: Motor Cortex Stimulation |
| Motor Cortex Stimulation for lower-limb prosthesis | Experimental | Procedure: Motor Cortex 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 |
|---|---|---|
| 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 for lower-limb prosthesis, Peripheral nerve stimulation for upper-limb prosthesis |
| 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 for lower-limb prosthesis, Spinal cord stimulation for upper-limb prosthesis |
| 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 for upper-limb prosthesis, Experimental: Dorsal root ganglion stimulation for lower-limb prosthesis |
| 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 for lower-limb prosthesis, Motor Cortex Stimulation for upper-limb prosthesis |
Primary outcome
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 months
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.
DN 4
Time frame: Up to 6 months
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.
6 secondary outcomes
Sensory threshold change
Time frame: At least three measurements. 1 - First week after implantation, 2 - Up to three months after implantation, 3 - Up to five months after implantation
Agency
Time frame: Up to 6 months
Embodiment
Time frame: Up to 6 months
Pain detect
Time frame: Up to 6 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: Up to 6 months
Ownership
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 25 Nov 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 Peripheral Nerve Stimulation, Spinal cord stimulation and Dorsal Root Ganglion 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 25 Nov 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 Matvienko (+79163843070, yumedteam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: up to 4 months). The study lists 3 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 25 Nov 2024.