Study of Phantom Limb Pain Using Peripheral Nerve and Spinal Cord Stimulation

NCT05650931 | Unknown

• 1 other identifier: DVFU-09
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Phantom Limb Pain; Phantom Pain; Amputation

Keywords

neurostimulation; spinal cord stimulation; phantom limb pain; pain suppression; upper-limb amputation

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  up to 1 month

Secondary Outcomes (2)

• Change according to the SF-36 scale "Quality of Life Assessment"

  baseline and up to 1 month

• Change according to the Trinity Amputation and Prosthetics Research Scale (TAPES-R)

  baseline and up to 1 month

Study Arms (1)

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

Interventions

Implantation of PNS electrodes during surgery, mapping to select sites with the best effect and pain modulation. PROCEDURE

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.

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. PROCEDURE

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.

Patients who underwent the upper limb amputation and have phantom limb pain

EEG to search for phantom pain biomarkers PROCEDURE

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.

Patients who underwent the upper limb amputation and have phantom limb pain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Purulent - septic pathology.
• Drug addiction.
• Congenital malformation of the upper limb.

Sponsors & Collaborators

• Artur Biktimirov: lead

Study Sites (1)

Far Eastern Federal University (FEFU)

Vladivostok, Primorskiy (Maritime) Kray, 690922, Russia

Location

Related Publications (11)

• 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.

  PMID: 34062145 BACKGROUND

• Schiefer 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.

  PMID: 26643802 BACKGROUND

• 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.

  PMID: 27797958 BACKGROUND

• 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.

  PMID: 31870766 BACKGROUND

• 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.

  PMID: 32348644 BACKGROUND

• 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.

  PMID: 25298320 BACKGROUND

• 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.

  PMID: 30517154 BACKGROUND

• 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.

  PMID: 30474259 BACKGROUND

• 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.

  PMID: 24500407 BACKGROUND

• Soghoyan 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.

  PMID: 39654645 DERIVED

• Soghoyan 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.

  PMID: 37100202 DERIVED

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Far Eastern Federal University

Study Record Dates

• First Submitted: November 19, 2022
• First Posted: December 14, 2022
• Study Start: November 1, 2021
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 14, 2022

Record last verified: 2022-12

Locations

RU (1)