Phantom Limb PainNCT05650931
Study of Phantom Limb Pain Using Peripheral Nerve and Spinal Cord Stimulation
A study testing Implantation of PNS electrodes during surgery, mapping to select sites with the best effect and pain modulation., SCS electrode implantation at surgery, mapping to select sites with the best effect and pain modulation. and EEG to search for phantom pain biomarkers in people with Phantom Limb Pain and Phantom Pain, run by Artur Biktimirov at 1 site in Russia.
Trial summary
The purpose of this study is to evaluate the effectiveness of neuromodulation for relief of phantom limb pain (PLP) using peripheral nerve (PNS) and spinal cord (SCS) stimulation with implantable electrodes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Phantom Limb Pain, Phantom Pain, Amputation
- What is being tested?
- Implantation of PNS electrodes during surgery, mapping to select sites with the best effect and pain modulation., SCS electrode implantation at surgery, mapping to select sites with the best effect and pain modulation. and EEG to search for phantom pain biomarkers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2021to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients with implanted neuromodulation devices.
- Amputation of the upper limb at the level of the forearm.
- Age ranges from 18 to 65 years old.
- The duration from the moment of amputation is from 6 months.
- The presence of persistent chronic pain syndrome is from 4 to 10 points according to the Visual Analogue Scale
- Absence of pregnancy at the time of implantation, confirmed by a pregnancy test.
Who cannot join
- The presence of severe somatic pathology
- The presence of mental illness
- The presence of a gross orthopedic deformity in the limb above the amputation level.
- The presence of oncology.
- The presence of epilepsy.
- Complications after a traumatic brain injury or stroke.
Show all 10Show fewer
- Purulent - septic pathology.
- Drug addiction.
- Congenital malformation of the upper limb.
- Any conditions that, according to the researcher, fall under the exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Far Eastern Federal University (FEFU)
Vladivostok, Primorskiy (Maritime) Kray, 690922
About this study
Official title: Peripheral Nerve Stimulation and Spinal Cord Stimulation in Patients With Phantom Limb Pain After Upper Limb Amputation for Phantom Limb Pain Suppression and Development of the Biomarkers
The purpose of this study is to evaluate the effectiveness of neuromodulation for relief of phantom limb pain (PLP) using peripheral nerve (PNS) and spinal cord (SCS) stimulation with implantable electrodes. The researchers expect that PLP in patients with upper limb amputation will be relieved by peripheral nerve and the spinal cord stimulation. The possibility of finding EEG biomarkers for phantom pain will be explored.
Read the detailed description
The purpose of this study is to evaluate the effectiveness of neuromodulation for relief of phantom limb pain (PLP) using peripheral nerve (PNS) and spinal cord stimulation (SCS) with implantable electrodes.
The study is conducted to collect information on the role of non-adaptive neuroplasticity and inhibitory descending antinociceptive influences, which determine the effect of peripheral nerve and spinal cord stimulation with implanted electrodes in patients with phantom limb pain as a result of amputation of the upper limb. Neuromodulation is a potential treatment option for chronic pain that may alter maladaptive neuroplasticity and enhance descending inhibitory pathways.
Study participants will be selected according to the inclusion criteria. Next, multichannel electrodes will be implanted in the region of the target peripheral nerves of the amputated limb and the corresponding segments of the spinal cord. The evaluation of the therapeutic effects of pain syndromes will be carried out in the mode of long-term repetitive nerve stimulation. Postoperative follow-up will be carried out from 2 weeks to 1 month. During the follow-up period, patients will complete scales and questionnaires daily.
The stimulator is turned on the day after surgery to assess pain relief. The patient is explained the rules for using the stimulator. The selection of stimulation parameters is carried out according to the generally accepted methodology (the stimulation zone should overlap the pain zone; stimulation should be in the nature of pleasant vibrations). The patient will be given a test stimulation diary to complete every day (at the end of the day) during the entire stimulation period.
The researchers expect that phantom limb pain in patients undergoing upper limb amputation will be relieved by peripheral nerve stimulation. We will explore the possibility of creating a personal phantom sensitivity map to optimize the stimulation program. We will study improving the quality of life and reducing pain.
Patients will be asked to participate in an experiment using electroencephalography (EEG) starting on the 3rd day after implantation. The purpose of this entry is to investigate the bimarkers of phantom pain. As part of the experimental procedure, we plan to sequentially turn off the stimulator until the patient returns to the preoperative pain state, and also turn on the stimulator with fixation of the moments of pain suppression to the level at the beginning of the experiment. During the entire period, the patient's EEG will be recorded. The researchers expect to see changes in alpha and theta EEG rhythms under these experimental conditions.
- Conditions
- Phantom Limb Pain, Phantom Pain, Amputation
- Being tested
- Implantation of PNS electrodes during surgery, mapping to select sites with the best effect and pain modulation., SCS electrode implantation at surgery, mapping to select sites with the best effect and pain modulation., EEG to search for phantom pain biomarkers
- Keywords
- neurostimulation, spinal cord stimulation, phantom limb pain, pain suppression, upper-limb amputation
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of PNS electrodes during surgery, mapping to select sites with the best effect and pain modulation.Procedure or surgery
PNS electrodes are implanted in the area of peripheral nerves of the amputated limb. During phantom pain mapping, multichannel electrodes are used to stimulate peripheral nerves at different sites in the stump. Stimulation turns on sequentially at different stimulation sites; sites are selected where pain is most effectively suppressed. These sites are assigned to the patient for daily modulation.
SCS electrode implantation at surgery, mapping to select sites with the best effect and pain modulation.Procedure or surgery
SNS electrodes are implanted in the area of targeted peripheral nerves in the amputated limb. During phantom pain mapping, multichannel electrodes are used to stimulate the spinal cord at different sites in the cervical thickening (C5-T1). Stimulation starts at a specific site at a frequency of 1 Hz and increases by 0.1 Hz until the patient no longer feels phantom pain. Stimulation turns on sequentially at different stimulation sites; sites are selected where pain is most effectively suppressed. These sites are assigned to the patient for daily modulation.
EEG to search for phantom pain biomarkersProcedure or surgery
This procedure uses the method of electroencephalography (EEG). EEG signals are recorded during the entire experiment. First, the patient is recorded at rest with stimulator on (PNS/SCS) with eyes open and then closed, in the stimulator off state (eyes open, then closed) when patient's pain returns to its preoperative state. The stimulation is then turned back on to the original level of pain suppression. The moments of pain suppression are fixed by marking.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent the upper limb amputation and have phantom limb pain | Experimental | Not described Receives: Procedure: Implantation of PNS electrodes during surgery, mapping to select sites with the best effect and pain modulation.; Procedure: SCS electrode implantation at surgery, mapping to select sites with the best effect and pain modulation.; Procedure: EEG to search for phantom pain biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the effectiveness of phantom pain suppression based on the Test Stimulation Diary
The patient completes a Test Stimulation Diary at the end of each day, noting the location of phantom pain and the percentage of pain reduction during stimulation.
Measured: up to 1 month
Change according to the scale of the DN4 Neuropathic Pain Questionnaire
The DN4 Neuropathic Pain Questionnaire defines the neuropathic nature of pain with a point of 4 to 10.
Measured: baseline and up to 1 month
Change according to the scale of the PainDetect questionnaire
The PainDetect questionnaire reflects all possible parameters of pain and allows us to very clearly track the picture of the pain syndrome in dynamics. The score is made in the range from 0 (best score) to 38 (worst score) points.
Measured: up to 1 month
Change in relative power of slow frequencies (alpha and theta rhythms) on the EEG with the neurostimulator on/off and eyes open/closed.
The general analysis pipeline includes the calculation of the normalized power spectral density, after which the average power of the alpha rhythm is divided by the average power of the theta rhythm.
Measured: up to 1 month
Secondary outcomes (2)
Change according to the SF-36 scale "Quality of Life Assessment"
The SF-36 questionnaire consists of eight scales: physical functioning, role-playing, bodily pain, general health, vitality, social functioning, emotional state, and mental health. Each scale varies between 0 (worst score) and 100 (best score) points.
Measured: baseline and up to 1 month
Change according to the Trinity Amputation and Prosthetics Research Scale (TAPES-R)
TAPES-R reflects 3 aspects of psychosocial adjustment (general adjustment, social adjustment and adjustment to functional limitations) and 2 aspects (aesthetics and functionality) of prosthesis satisfaction. The answers reflect the degree of agreement with the statement indicated in the item of the questionnaire, or the degree of satisfaction, or the degree of limitation. The scores on the items of the individual subscales are summarized.
Measured: baseline and up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Nov 2021
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artur Biktimirov
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Artur Biktimirov, Far Eastern Federal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650931
- Sponsor's protocol ID
- DVFU-09
- Status last verified
- Dec 2022
- First submitted
- 19 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Our institution discovers this possibilities to share the data after the study
Publications
Knotkova H, Hamani C, Sivanesan E, Le Beuffe MFE, Moon JY, Cohen SP, Huntoon MA. Neuromodulation for chronic pain. Lancet. 2021 May 29;397(10289):2111-2124. doi: 10.1016/S0140-6736(21)00794-7.
PubMed 34062145Schiefer M, Tan D, Sidek SM, Tyler DJ. Sensory feedback by peripheral nerve stimulation improves task performance in individuals with upper limb loss using a myoelectric prosthesis. J Neural Eng. 2016 Feb;13(1):016001. doi: 10.1088/1741-2560/13/1/016001. Epub 2015 Dec 8.
PubMed 26643802Graczyk EL, Schiefer MA, Saal HP, Delhaye BP, Bensmaia SJ, Tyler DJ. The neural basis of perceived intensity in natural and artificial touch. Sci Transl Med. 2016 Oct 26;8(362):362ra142. doi: 10.1126/scitranslmed.aaf5187.
PubMed 27797958Mekhail N, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, Hunter CW, Rosen SM, Costandi SJ, Falowski SM, Burgher AH, Pope JE, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, Carlson J, Kim CK, Yang MI, Stauss T, Poree L; Evoke Study Group. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial. Lancet Neurol. 2020 Feb;19(2):123-134. doi: 10.1016/S1474-4422(19)30414-4. Epub 2019 Dec 20.
PubMed 31870766Ortiz-Catalan M, Mastinu E, Sassu P, Aszmann O, Branemark R. Self-Contained Neuromusculoskeletal Arm Prostheses. N Engl J Med. 2020 Apr 30;382(18):1732-1738. doi: 10.1056/NEJMoa1917537.
PubMed 32348644Tan DW, Schiefer MA, Keith MW, Anderson JR, Tyler J, Tyler DJ. A neural interface provides long-term stable natural touch perception. Sci Transl Med. 2014 Oct 8;6(257):257ra138. doi: 10.1126/scitranslmed.3008669.
PubMed 25298320Schiefer MA, Graczyk EL, Sidik SM, Tan DW, Tyler DJ. Artificial tactile and proprioceptive feedback improves performance and confidence on object identification tasks. PLoS One. 2018 Dec 5;13(12):e0207659. doi: 10.1371/journal.pone.0207659. eCollection 2018.
PubMed 30517154Petrini FM, Valle G, Strauss I, Granata G, Di Iorio R, D'Anna E, Cvancara P, Mueller M, Carpaneto J, Clemente F, Controzzi M, Bisoni L, Carboni C, Barbaro M, Iodice F, Andreu D, Hiairrassary A, Divoux JL, Cipriani C, Guiraud D, Raffo L, Fernandez E, Stieglitz T, Raspopovic S, Rossini PM, Micera S. Six-Month Assessment of a Hand Prosthesis with Intraneural Tactile Feedback. Ann Neurol. 2019 Jan;85(1):137-154. doi: 10.1002/ana.25384. Epub 2018 Dec 24.
PubMed 30474259Raspopovic S, Capogrosso M, Petrini FM, Bonizzato M, Rigosa J, Di Pino G, Carpaneto J, Controzzi M, Boretius T, Fernandez E, Granata G, Oddo CM, Citi L, Ciancio AL, Cipriani C, Carrozza MC, Jensen W, Guglielmelli E, Stieglitz T, Rossini PM, Micera S. Restoring natural sensory feedback in real-time bidirectional hand prostheses. Sci Transl Med. 2014 Feb 5;6(222):222ra19. doi: 10.1126/scitranslmed.3006820.
PubMed 24500407Soghoyan G, Biktimirov AR, Piliugin NS, Matvienko Y, Kaplan AY, Sintsov MY, Lebedev MA. Restoration of natural somatic sensations to the amputees: finding the right combination of neurostimulation methods. Front Neurosci. 2024 Nov 25;18:1466684. doi: 10.3389/fnins.2024.1466684. eCollection 2024.
PubMed 39654645Soghoyan G, Biktimirov A, Matvienko Y, Chekh I, Sintsov M, Lebedev MA. Peripheral nerve stimulation enables somatosensory feedback while suppressing phantom limb pain in transradial amputees. Brain Stimul. 2023 May-Jun;16(3):756-758. doi: 10.1016/j.brs.2023.04.017. Epub 2023 Apr 24.
PubMed 37100202
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Stimulation and Spinal Cord Stimulation in Patients With Phantom Limb Pain After Upper Limb Amputation for Phantom Limb Pain Suppression and Development of the Biomarkers
- ClinicalTrials.gov ID
- NCT05650931
- Acronym / sponsor ID
- DVFU-09
- Conditions
- Phantom Limb Pain, Phantom Pain, Amputation
- Keywords
- neurostimulation, spinal cord stimulation, phantom limb pain, pain suppression, upper-limb amputation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Artur BiktimirovUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 14 Dec 2022 (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 purpose of this study is to evaluate the effectiveness of neuromodulation for relief of phantom limb pain (PLP) using peripheral nerve (PNS) and spinal cord (SCS) stimulation with implantable electrodes. The researchers expect that PLP in patients with upper limb amputation will be relieved by peripheral nerve and the spinal cord stimulation. The possibility of finding EEG biomarkers for phantom pain will be explored.
Detailed description
The purpose of this study is to evaluate the effectiveness of neuromodulation for relief of phantom limb pain (PLP) using peripheral nerve (PNS) and spinal cord stimulation (SCS) with implantable electrodes.
The study is conducted to collect information on the role of non-adaptive neuroplasticity and inhibitory descending antinociceptive influences, which determine the effect of peripheral nerve and spinal cord stimulation with implanted electrodes in patients with phantom limb pain as a result of amputation of the upper limb. Neuromodulation is a potential treatment option for chronic pain that may alter maladaptive neuroplasticity and enhance descending inhibitory pathways.
Study participants will be selected according to the inclusion criteria. Next, multichannel electrodes will be implanted in the region of the target peripheral nerves of the amputated limb and the corresponding segments of the spinal cord. The evaluation of the therapeutic effects of pain syndromes will be carried out in the mode of long-term repetitive nerve stimulation. Postoperative follow-up will be carried out from 2 weeks to 1 month. During the follow-up period, patients will complete scales and questionnaires daily.
The stimulator is turned on the day after surgery to assess pain relief. The patient is explained the rules for using the stimulator. The selection of stimulation parameters is carried out according to the generally accepted methodology (the stimulation zone should overlap the pain zone; stimulation should be in the nature of pleasant vibrations). The patient will be given a test stimulation diary to complete every day (at the end of the day) during the entire stimulation period.
The researchers expect that phantom limb pain in patients undergoing upper limb amputation will be relieved by peripheral nerve stimulation. We will explore the possibility of creating a personal phantom sensitivity map to optimize the stimulation program. We will study improving the quality of life and reducing pain.
Patients will be asked to participate in an experiment using electroencephalography (EEG) starting on the 3rd day after implantation. The purpose of this entry is to investigate the bimarkers of phantom pain. As part of the experimental procedure, we plan to sequentially turn off the stimulator until the patient returns to the preoperative pain state, and also turn on the stimulator with fixation of the moments of pain suppression to the level at the beginning of the experiment. During the entire period, the patient's EEG will be recorded. The researchers expect to see changes in alpha and theta EEG rhythms under these experimental conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent the upper limb amputation and have phantom limb pain | Experimental | Procedure: Implantation of PNS electrodes during surgery, mapping to select sites with the best effect and pain modulation., Procedure: SCS electrode implantation at surgery, mapping to select sites with the best effect and pain modulation., Procedure: EEG to search for phantom pain biomarkers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with implanted neuromodulation devices.
- Amputation of the upper limb at the level of the forearm.
- Age ranges from 18 to 65 years old.
- The duration from the moment of amputation is from 6 months.
- The presence of persistent chronic pain syndrome is from 4 to 10 points according to the Visual Analogue Scale
Key exclusion criteria (10 listed)
- The presence of severe somatic pathology
- The presence of mental illness
- The presence of a gross orthopedic deformity in the limb above the amputation level.
- The presence of oncology.
- The presence 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 |
|---|---|---|
| Implantation of PNS electrodes during surgery, mapping to select sites with the best effect and pain modulation.PNS electrodes are implanted in the area of peripheral nerves of the amputated limb. During phantom pain mapping, multichannel electrodes are used to stimulate peripheral nerves at different sites in the stump. Stimulation turns on sequentially at different stimulation sites; sites are selected where pain is most effectively suppressed. These sites are assigned to the patient for daily modulation. | Procedure or surgery | Patients who underwent the upper limb amputation and have phantom limb pain |
| SCS electrode implantation at surgery, mapping to select sites with the best effect and pain modulation.SNS electrodes are implanted in the area of targeted peripheral nerves in the amputated limb. During phantom pain mapping, multichannel electrodes are used to stimulate the spinal cord at different sites in the cervical thickening (C5-T1). Stimulation starts at a specific site at a frequency of 1 Hz and increases by 0.1 Hz until the patient no longer feels phantom pain. Stimulation turns on sequentially at different stimulation sites; sites are selected where pain is most effectively suppressed. These sites are assigned to the patient for daily modulation. | Procedure or surgery | Patients who underwent the upper limb amputation and have phantom limb pain |
| EEG to search for phantom pain biomarkersThis procedure uses the method of electroencephalography (EEG). EEG signals are recorded during the entire experiment. First, the patient is recorded at rest with stimulator on (PNS/SCS) with eyes open and then closed, in the stimulator off state (eyes open, then closed) when patient's pain returns to its preoperative state. The stimulation is then turned back on to the original level of pain suppression. The moments of pain suppression are fixed by marking. | Procedure or surgery | Patients who underwent the upper limb amputation and have phantom limb pain |
Primary outcome
Determining the effectiveness of phantom pain suppression based on the Test Stimulation Diary
Time frame: up to 1 month
The patient completes a Test Stimulation Diary at the end of each day, noting the location of phantom pain and the percentage of pain reduction during stimulation.
Change according to the scale of the DN4 Neuropathic Pain Questionnaire
Time frame: baseline and up to 1 month
The DN4 Neuropathic Pain Questionnaire defines the neuropathic nature of pain with a point of 4 to 10.
Change according to the scale of the PainDetect questionnaire
Time frame: up to 1 month
The PainDetect questionnaire reflects all possible parameters of pain and allows us to very clearly track the picture of the pain syndrome in dynamics. The score is made in the range from 0 (best score) to 38 (worst score) points.
Change in relative power of slow frequencies (alpha and theta rhythms) on the EEG with the neurostimulator on/off and eyes open/closed.
Time frame: up to 1 month
The general analysis pipeline includes the calculation of the normalized power spectral density, after which the average power of the alpha rhythm is divided by the average power of the theta rhythm.
2 secondary outcomes
Change according to the SF-36 scale "Quality of Life Assessment"
Time frame: baseline and up to 1 month
Change according to the Trinity Amputation and Prosthetics Research Scale (TAPES-R)
Time frame: baseline and up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Background: PubMed 34062145Knotkova H, Hamani C, Sivanesan E, Le Beuffe MFE, Moon JY, Cohen SP, Huntoon MA. Neuromodulation for chronic pain. Lancet. 2021 May 29;397(10289):2111-2124. doi: 10.1016/S0140-6736(21)00794-7.
- Background: PubMed 26643802Schiefer M, Tan D, Sidek SM, Tyler DJ. Sensory feedback by peripheral nerve stimulation improves task performance in individuals with upper limb loss using a myoelectric prosthesis. J Neural Eng. 2016 Feb;13(1):016001. doi: 10.1088/1741-2560/13/1/016001. Epub 2015 Dec 8.
- Background: PubMed 27797958Graczyk EL, Schiefer MA, Saal HP, Delhaye BP, Bensmaia SJ, Tyler DJ. The neural basis of perceived intensity in natural and artificial touch. Sci Transl Med. 2016 Oct 26;8(362):362ra142. doi: 10.1126/scitranslmed.aaf5187.
- Background: PubMed 31870766Mekhail N, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, Hunter CW, Rosen SM, Costandi SJ, Falowski SM, Burgher AH, Pope JE, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, Carlson J, Kim CK, Yang MI, Stauss T, Poree L; Evoke Study Group. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial. Lancet Neurol. 2020 Feb;19(2):123-134. doi: 10.1016/S1474-4422(19)30414-4. Epub 2019 Dec 20.
- Background: PubMed 32348644Ortiz-Catalan M, Mastinu E, Sassu P, Aszmann O, Branemark R. Self-Contained Neuromusculoskeletal Arm Prostheses. N Engl J Med. 2020 Apr 30;382(18):1732-1738. doi: 10.1056/NEJMoa1917537.
- Background: PubMed 25298320Tan DW, Schiefer MA, Keith MW, Anderson JR, Tyler J, Tyler DJ. A neural interface provides long-term stable natural touch perception. Sci Transl Med. 2014 Oct 8;6(257):257ra138. doi: 10.1126/scitranslmed.3008669.
- Background: PubMed 30517154Schiefer MA, Graczyk EL, Sidik SM, Tan DW, Tyler DJ. Artificial tactile and proprioceptive feedback improves performance and confidence on object identification tasks. PLoS One. 2018 Dec 5;13(12):e0207659. doi: 10.1371/journal.pone.0207659. eCollection 2018.
- Background: PubMed 30474259Petrini FM, Valle G, Strauss I, Granata G, Di Iorio R, D'Anna E, Cvancara P, Mueller M, Carpaneto J, Clemente F, Controzzi M, Bisoni L, Carboni C, Barbaro M, Iodice F, Andreu D, Hiairrassary A, Divoux JL, Cipriani C, Guiraud D, Raffo L, Fernandez E, Stieglitz T, Raspopovic S, Rossini PM, Micera S. Six-Month Assessment of a Hand Prosthesis with Intraneural Tactile Feedback. Ann Neurol. 2019 Jan;85(1):137-154. doi: 10.1002/ana.25384. Epub 2018 Dec 24.
- Background: PubMed 24500407Raspopovic S, Capogrosso M, Petrini FM, Bonizzato M, Rigosa J, Di Pino G, Carpaneto J, Controzzi M, Boretius T, Fernandez E, Granata G, Oddo CM, Citi L, Ciancio AL, Cipriani C, Carrozza MC, Jensen W, Guglielmelli E, Stieglitz T, Rossini PM, Micera S. Restoring natural sensory feedback in real-time bidirectional hand prostheses. Sci Transl Med. 2014 Feb 5;6(222):222ra19. doi: 10.1126/scitranslmed.3006820.
- Derived from this study: PubMed 39654645Soghoyan G, Biktimirov AR, Piliugin NS, Matvienko Y, Kaplan AY, Sintsov MY, Lebedev MA. Restoration of natural somatic sensations to the amputees: finding the right combination of neurostimulation methods. Front Neurosci. 2024 Nov 25;18:1466684. doi: 10.3389/fnins.2024.1466684. eCollection 2024.
- Derived from this study: PubMed 37100202Soghoyan G, Biktimirov A, Matvienko Y, Chekh I, Sintsov M, Lebedev MA. Peripheral nerve stimulation enables somatosensory feedback while suppressing phantom limb pain in transradial amputees. Brain Stimul. 2023 May-Jun;16(3):756-758. doi: 10.1016/j.brs.2023.04.017. Epub 2023 Apr 24.
- Individual participant dataSharing planned: Undecided. Our institution discovers this possibilities to share the data after the study
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of PNS electrodes during surgery, mapping to select sites with the best effect and pain modulation., SCS electrode implantation at surgery, mapping to select sites with the best effect and pain modulation. and EEG to search for phantom pain biomarkers in people with Phantom Limb Pain and Phantom Pain, run by Artur Biktimirov 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 14 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the effectiveness of phantom pain suppression based on the Test Stimulation Diary (time frame: up to 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05650931, which also lists 11 linked publications.
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 14 Dec 2022.