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

Primary Purpose

Phantom Limb Pain, Phantom Pain, Amputation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
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
Sponsored by
Artur Biktimirov
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phantom Limb Pain focused on measuring neurostimulation, spinal cord stimulation, phantom limb pain, pain suppression, upper-limb amputation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. Any conditions that, according to the researcher, fall under the exclusion criteria.

Sites / Locations

  • Far Eastern Federal University (FEFU)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 19, 2022
Last Updated
December 6, 2022
Sponsor
Artur Biktimirov
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1. Study Identification

Unique Protocol Identification Number
NCT05650931
Brief Title
Study of Phantom Limb Pain Using Peripheral Nerve and Spinal Cord Stimulation
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Artur Biktimirov

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain, Phantom Pain, Amputation
Keywords
neurostimulation, spinal cord stimulation, phantom limb pain, pain suppression, upper-limb amputation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients who underwent the upper limb amputation and have phantom limb pain
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Implantation of PNS electrodes during surgery, mapping to select sites with the best effect and pain modulation.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
SCS electrode implantation at surgery, mapping to select sites with the best effect and pain modulation.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
EEG to search for phantom pain biomarkers
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determining the effectiveness of phantom pain suppression based on the Test Stimulation Diary
Description
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.
Time Frame
up to 1 month
Title
Change according to the scale of the DN4 Neuropathic Pain Questionnaire
Description
The DN4 Neuropathic Pain Questionnaire defines the neuropathic nature of pain with a point of 4 to 10.
Time Frame
baseline and up to 1 month
Title
Change according to the scale of the PainDetect questionnaire
Description
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.
Time Frame
up to 1 month
Title
Change in relative power of slow frequencies (alpha and theta rhythms) on the EEG with the neurostimulator on/off and eyes open/closed.
Description
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.
Time Frame
up to 1 month
Secondary Outcome Measure Information:
Title
Change according to the SF-36 scale "Quality of Life Assessment"
Description
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.
Time Frame
baseline and up to 1 month
Title
Change according to the Trinity Amputation and Prosthetics Research Scale (TAPES-R)
Description
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.
Time Frame
baseline and up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Any conditions that, according to the researcher, fall under the exclusion criteria.
Facility Information:
Facility Name
Far Eastern Federal University (FEFU)
City
Vladivostok
State/Province
Primorsky Krai
ZIP/Postal Code
690922
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Our institution discovers this possibilities to share the data after the study
Citations:
PubMed Identifier
34062145
Citation
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Results Reference
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26643802
Citation
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.
Results Reference
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PubMed Identifier
27797958
Citation
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.
Results Reference
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Citation
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.
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Citation
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.
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Study of Phantom Limb Pain Using Peripheral Nerve and Spinal Cord Stimulation

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