Phantom Limb PainNCT05807607

Study of Lower-limb Phantom Pain Syndrome 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 daily modulation., SCS electrode implantation at surgery, mapping to select sites with the best effect and pain modulation and Change according to the scale of the PainDetect questionnaire in people with Phantom Limb Pain and Phantom Pain, run by Artur Biktimirov at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

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 daily modulation., SCS electrode implantation at surgery, mapping to select sites with the best effect and pain modulation and Change according to the scale of the PainDetect questionnaire
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: 17 Nov 2022to 1 Dec 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 lower limb.
Age ranges from 18 to 65 years old.
The duration from the moment of amputation is from 12 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 that prevents surgical treatment and participation in the study.
The presence of mental illness (including history), severe depression, suicidal tendencies, history of suicide.
The presence of gross orthopedic deformity in the limb above the amputation level.
History of oncology.
History of epilepsy.
Complicated TBI or history of stroke.

Show all 12Show fewer

The impossibility of conducting electrical stimulation due to another somatic pathology.
Purulent septic pathology.
Drug addiction (including history).
Congenital malformation of the lower limb.
Anomalies in the development of the CNS.
Any conditions that fall under the exclusion criteria according to the researchers.

Trial locations and contacts

1 site in 1 country.

Russia1 site

Far Eastern Federal University (FEFU)
Vladivostok, Primorskiy (Maritime) Kray, 690922

Other trials in Russia

About this study

Official title: Peripheral Nerve and Spinal Cord Stimulation in Patients With Pain Syndrome as a Result of Lower Limb Amputation in Order to Relieve Pain Syndrome and Develop Phantom Pain Biomarkers

Brief 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. The researchers expect that PLP in patients with lower 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 lower 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 lower 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 biomarkers 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, Lower Limb Amputation
Being tested: Implantation of PNS electrodes during surgery, mapping to select sites with the best effect and daily modulation., SCS electrode implantation at surgery, mapping to select sites with the best effect and pain modulation, Change according to the scale of the PainDetect questionnaire
Keywords: Neurostimulation, Spinal cord stimulation, Peripheral nerve stimulation, Phantom limb pain, Pain suppression, Lower-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 daily 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 modulationProcedure or surgery
SСS 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. 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.
Change according to the scale of the PainDetect questionnaireProcedure 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) in order to return the patient to the 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 groups in NCT05807607
Study group	Role	What they receive
Patients who underwent the lower limb amputation and have phantom pain syndrome	Experimental	Not described Receives: Procedure: Implantation of PNS electrodes during surgery, mapping to select sites with the best effect and daily modulation.; Procedure: SCS electrode implantation at surgery, mapping to select sites with the best effect and pain modulation; Procedure: Change according to the scale of the PainDetect questionnaire

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 in slow frequencies (alpha and theta ranges) on the EEG with the neurostimulator on/off and eyes open/closed.
Data analysis is done in MNE Python. An average reference is used. Artifact correction is carried out using the analysis of independent components. Additionally, band-pass filtering is applied in the range from 1 to 40 Hz. 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. This ratio is compared under different experimental conditions
Measured: 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.

17 Nov 20221 Dec 2025

First posted11 Apr 2023
Study start17 Nov 2022
Primary completion1 Nov 2025 (estimated)
Study completion1 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05807607
Sponsor's protocol ID: DVFU-10
Status last verified: Mar 2023
First submitted: 29 Mar 2023
Last updated: 11 Apr 2023
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 34062145
Graczyk 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 27797958
Mekhail 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 31870766
Ortiz-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 32348644
Tan 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 25298320
Schiefer 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 30517154
Petrini 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 30474259
Raspopovic 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 24500407
Dietrich C, Nehrdich S, Seifert S, Blume KR, Miltner WHR, Hofmann GO, Weiss T. Leg Prosthesis With Somatosensory Feedback Reduces Phantom Limb Pain and Increases Functionality. Front Neurol. 2018 Apr 26;9:270. doi: 10.3389/fneur.2018.00270. eCollection 2018.
PubMed 29755399
Naschitz JE, Lenger R. Why traumatic leg amputees are at increased risk for cardiovascular diseases. QJM. 2008 Apr;101(4):251-9. doi: 10.1093/qjmed/hcm131. Epub 2008 Feb 16.
PubMed 18281705
Petrini FM, Bumbasirevic M, Valle G, Ilic V, Mijovic P, Cvancara P, Barberi F, Katic N, Bortolotti D, Andreu D, Lechler K, Lesic A, Mazic S, Mijovic B, Guiraud D, Stieglitz T, Alexandersson A, Micera S, Raspopovic S. Sensory feedback restoration in leg amputees improves walking speed, metabolic cost and phantom pain. Nat Med. 2019 Sep;25(9):1356-1363. doi: 10.1038/s41591-019-0567-3. Epub 2019 Sep 9.
PubMed 31501600
Rathnayake A, Saboo A, Malabu UH, Falhammar H. Lower extremity amputations and long-term outcomes in diabetic foot ulcers: A systematic review. World J Diabetes. 2020 Sep 15;11(9):391-399. doi: 10.4239/wjd.v11.i9.391.
PubMed 32994867

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Phantom Limb Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Peripheral Nerve and Spinal Cord Stimulation in Patients With Pain Syndrome as a Result of Lower Limb Amputation in Order to Relieve Pain Syndrome and Develop Phantom Pain Biomarkers
ClinicalTrials.gov ID: NCT05807607
Acronym / sponsor ID: DVFU-10
Conditions: Phantom Limb Pain, Phantom Pain, Amputation, Lower Limb Amputation
Keywords: Neurostimulation, Spinal cord stimulation, Peripheral nerve stimulation, Phantom limb pain, Pain suppression, Lower-limb amputation
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 10 participants (estimated)
Lead sponsor: Artur BiktimirovUniversity, hospital or other
Study start: 17 Nov 2022 (actual)
Primary completion: 1 Nov 2025 (estimated)
Study completion: 1 Dec 2025 (estimated)
First posted: 11 Apr 2023 (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.

Detailed description

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 lower limb amputation and have phantom pain syndrome	Experimental	Procedure: Implantation of PNS electrodes during surgery, mapping to select sites with the best effect and daily modulation., Procedure: SCS electrode implantation at surgery, mapping to select sites with the best effect and pain modulation, Procedure: Change according to the scale of the PainDetect questionnaire

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 lower limb.
Age ranges from 18 to 65 years old.
The duration from the moment of amputation is from 12 months.
The presence of persistent chronic pain syndrome is from 4 to 10 points according to the Visual Analogue Scale

Key exclusion criteria (12 listed)

The presence of severe somatic pathology that prevents surgical treatment and participation in the study.
The presence of mental illness (including history), severe depression, suicidal tendencies, history of suicide.
The presence of gross orthopedic deformity in the limb above the amputation level.
History of oncology.
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
Implantation of PNS electrodes during surgery, mapping to select sites with the best effect and daily 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 lower limb amputation and have phantom pain syndrome
SCS electrode implantation at surgery, mapping to select sites with the best effect and pain modulationSСS 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. 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 lower limb amputation and have phantom pain syndrome
Change according to the scale of the PainDetect questionnaireThis 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) in order to return the patient to the 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 lower limb amputation and have phantom pain syndrome

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 in slow frequencies (alpha and theta ranges) on the EEG with the neurostimulator on/off and eyes open/closed.
Time frame: up to 1 month
Data analysis is done in MNE Python. An average reference is used. Artifact correction is carried out using the analysis of independent components. Additionally, band-pass filtering is applied in the range from 1 to 40 Hz. 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. This ratio is compared under different experimental conditions

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
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 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.
Background: PubMed 29755399Dietrich C, Nehrdich S, Seifert S, Blume KR, Miltner WHR, Hofmann GO, Weiss T. Leg Prosthesis With Somatosensory Feedback Reduces Phantom Limb Pain and Increases Functionality. Front Neurol. 2018 Apr 26;9:270. doi: 10.3389/fneur.2018.00270. eCollection 2018.
Background: PubMed 18281705Naschitz JE, Lenger R. Why traumatic leg amputees are at increased risk for cardiovascular diseases. QJM. 2008 Apr;101(4):251-9. doi: 10.1093/qjmed/hcm131. Epub 2008 Feb 16.
Background: PubMed 31501600Petrini FM, Bumbasirevic M, Valle G, Ilic V, Mijovic P, Cvancara P, Barberi F, Katic N, Bortolotti D, Andreu D, Lechler K, Lesic A, Mazic S, Mijovic B, Guiraud D, Stieglitz T, Alexandersson A, Micera S, Raspopovic S. Sensory feedback restoration in leg amputees improves walking speed, metabolic cost and phantom pain. Nat Med. 2019 Sep;25(9):1356-1363. doi: 10.1038/s41591-019-0567-3. Epub 2019 Sep 9.
Background: PubMed 32994867Rathnayake A, Saboo A, Malabu UH, Falhammar H. Lower extremity amputations and long-term outcomes in diabetic foot ulcers: A systematic review. World J Diabetes. 2020 Sep 15;11(9):391-399. doi: 10.4239/wjd.v11.i9.391.
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?

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 12 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 11 Apr 2023. 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 NCT05807607, which also lists 12 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 11 Apr 2023.