Amputation Clinical Trial
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
Verified date | March 2023 |
Source | Far Eastern Federal University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 10 |
Est. completion date | December 1, 2025 |
Est. primary completion date | November 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion criteria for the study: - 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. Exclusion criteria: - 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. - 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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Far Eastern Federal University (FEFU) | Vladivostok | Primorsky Krai |
Lead Sponsor | Collaborator |
---|---|
Artur Biktimirov |
Russian Federation,
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. — View Citation
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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. — View Citation
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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. — View Citation
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. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | up to 1 month |
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