Pain in Parkinson's Disease: Exploration of the Serotonin System in Positron Emission Tomography (PET [18F]-MPPF)
NCT ID: NCT06008704
Last Updated: 2024-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
34 participants
INTERVENTIONAL
2024-01-01
2026-09-01
Brief Summary
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Detailed Description
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The present study hypothesize that the binding of the radiotracer \[18F\]-MPPF, allowing in vivo imaging of 5HT1A receptors, will be reduced in PD patients with central pain compared to non-painful PD patients at the level of the median raphe, but also at the level of several brain structures involved in the pain matrix such as the insula, the anterior and posterior cingulate cortex, the orbitofrontal cortex, etc. A correlation between the clinical parameters of pain and the brain structures in which MRP binding is decreased should make it possible to confirm the link between these serotonin binding anomalies and pain. Finally, the morphological and functional MRI study should make it possible to identify structural and functional abnormalities within the pain networks in painful Parkinson's patients.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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PD patients with central chronic pain
Patients from both groups will receive the same interventions, the difference between groups is the eligibility criteria. In this arm only patients presenting central chronic pain will be included
Clinical assessment
The clinical assessment consists on behavioural and motor evaluations to determine the characteristics of the population
Pain characteristics assessment
The pain characteristics assessment will be made with a variety of scales and questionnaires which allow to identify the extent of central pain and functional impairment
MRI
The MRI examination allows anatomical imaging, diffusion imaging and functional imaging to measure specific markers
Thermotest
The thermotest is performed to assess the pain perception threshold
UPDRS-III Scale
The UPDRS-III scale allows to asses motor functionality of PD patients
[18F]-MPPF PET scan
The PET scan after injection of \[18F\]-MPPF at a dose of 200 Megabecquerel/kg +/-10% allows in vivo imaging of 5HT1A receptors
PD patients without pain
Patients from both groups will receive the same interventions, the difference between groups is the eligibility criteria. In this arm only patients without central chronic pain will be included
Clinical assessment
The clinical assessment consists on behavioural and motor evaluations to determine the characteristics of the population
Pain characteristics assessment
The pain characteristics assessment will be made with a variety of scales and questionnaires which allow to identify the extent of central pain and functional impairment
MRI
The MRI examination allows anatomical imaging, diffusion imaging and functional imaging to measure specific markers
Thermotest
The thermotest is performed to assess the pain perception threshold
UPDRS-III Scale
The UPDRS-III scale allows to asses motor functionality of PD patients
[18F]-MPPF PET scan
The PET scan after injection of \[18F\]-MPPF at a dose of 200 Megabecquerel/kg +/-10% allows in vivo imaging of 5HT1A receptors
Interventions
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Clinical assessment
The clinical assessment consists on behavioural and motor evaluations to determine the characteristics of the population
Pain characteristics assessment
The pain characteristics assessment will be made with a variety of scales and questionnaires which allow to identify the extent of central pain and functional impairment
MRI
The MRI examination allows anatomical imaging, diffusion imaging and functional imaging to measure specific markers
Thermotest
The thermotest is performed to assess the pain perception threshold
UPDRS-III Scale
The UPDRS-III scale allows to asses motor functionality of PD patients
[18F]-MPPF PET scan
The PET scan after injection of \[18F\]-MPPF at a dose of 200 Megabecquerel/kg +/-10% allows in vivo imaging of 5HT1A receptors
Eligibility Criteria
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Inclusion Criteria
* Patients with stable anti-parkinsonian treatment for at least 4 weeks prior to inclusion
* Patients with a Montreal Cognitive Assessment (MoCA) score \> 25
* Patients with a Hospital Anxiety and Depression Scale (HADS)-D score ≥ 11
* Person affiliated or benefiting from a social security scheme.
* Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
• For patients with pain
* Patients with PD-related central pain defined according to the criteria of Marques et al, 2019
* Patients with chronic central pain (i.e. present for at least 3 months)
* Patients who have average pain over the previous month according to a VAS ≥ 4.
• For patients without pain
* Patients who do not have pain defined as VAS ≤ 4, meaning that it does not interfere with daily activity.
Exclusion Criteria
* Patients with a history of significant psychiatric pathology according to the investigator
* Patients treated with drugs interacting with 5HT1A receptors in the previous 4 weeks
* Patients with contraindication to MRI
* Patients refusing to be informed of an abnormality discovered during brain imaging
* Patients with dyskinesias judged by the investigator to be disabling for imaging.
* Patients under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision
* Pregnant woman, breastfeeding woman
40 Years
80 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Christine BREFEL-COURBON, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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Centre Hospitalier Universitaire de Toulouse
Toulouse, Haute-Garonne, France
Countries
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Central Contacts
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Christine BREFEL-COURBON, MD PhD
Role: CONTACT
Facility Contacts
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References
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Aznavour N, Zimmer L. [18F]MPPF as a tool for the in vivo imaging of 5-HT1A receptors in animal and human brain. Neuropharmacology. 2007 Mar;52(3):695-707. doi: 10.1016/j.neuropharm.2006.09.023. Epub 2006 Nov 13.
Boussac M, Arbus C, Dupouy J, Harroch E, Rousseau V, Ory-Magne F, Rascol O, Moreau C, Maltete D, Rouaud T, Meyer M, Houvenaghel JF, Marse C, Tranchant C, Hainque E, Jarraya B, Ansquer S, Bonnet M, Belamri L, Tir M, Marques AR, Danaila T, Eusebio A, Devos D, Brefel-Courbon C; PREDI-STIM study group*. Personality Dimensions Are Associated with Quality of Life in Fluctuating Parkinson's Disease Patients (PSYCHO-STIM). J Parkinsons Dis. 2020;10(3):1057-1066. doi: 10.3233/JPD-191903.
Boussac M, Arbus C, Dupouy J, Harroch E, Rousseau V, Croiset A, Ory-Magne F, Rascol O, Moreau C, Rolland AS, Maltete D, Rouaud T, Meyer M, Drapier S, Giordana B, Anheim M, Hainque E, Jarraya B, Benatru I, Auzou N, Belamri L, Tir M, Marques AR, Thobois S, Eusebio A, Corvol JC, Devos D, Brefel-Courbon C; PREDI-STIM study group. Personality dimensions of patients can change during the course of parkinson's disease. PLoS One. 2021 Jan 7;16(1):e0245142. doi: 10.1371/journal.pone.0245142. eCollection 2021.
Boussac M, Arbus C, Klinger H, Eusebio A, Hainque E, Corvol JC, Rascol O, Rousseau V, Harroch E, d'Apollonia CS, Croiset A, Ory-Magne F, De Barros A, Fabbri M, Moreau C, Rolland AS, Benatru I, Anheim M, Marques AR, Maltete D, Drapier S, Jarraya B, Hubsch C, Guehl D, Meyer M, Rouaud T, Giordana B, Tir M, Devos D, Brefel-Courbon C; PREDISTIM study group. Personality Related to Quality-of-Life Improvement After Deep Brain Stimulation in Parkinson's Disease (PSYCHO-STIM II). J Parkinsons Dis. 2022;12(2):699-711. doi: 10.3233/JPD-212883.
Brefel-Courbon C, Grolleau S, Thalamas C, Bourrel R, Allaria-Lapierre V, Loi R, Micallef-Roll J, Lapeyre-Mestre M. Comparison of chronic analgesic drugs prevalence in Parkinson's disease, other chronic diseases and the general population. Pain. 2009 Jan;141(1-2):14-8. doi: 10.1016/j.pain.2008.04.026. Epub 2008 Dec 4.
Brefel-Courbon C, Ory-Magne F, Thalamas C, Payoux P, Rascol O. Nociceptive brain activation in patients with neuropathic pain related to Parkinson's disease. Parkinsonism Relat Disord. 2013 May;19(5):548-52. doi: 10.1016/j.parkreldis.2013.02.003. Epub 2013 Feb 23.
Brefel-Courbon C, Payoux P, Thalamas C, Ory F, Quelven I, Chollet F, Montastruc JL, Rascol O. Effect of levodopa on pain threshold in Parkinson's disease: a clinical and positron emission tomography study. Mov Disord. 2005 Dec;20(12):1557-63. doi: 10.1002/mds.20629.
Chaudhuri KR, Schapira AH. Non-motor symptoms of Parkinson's disease: dopaminergic pathophysiology and treatment. Lancet Neurol. 2009 May;8(5):464-74. doi: 10.1016/S1474-4422(09)70068-7.
Chaudhuri KR, Rizos A, Trenkwalder C, Rascol O, Pal S, Martino D, Carroll C, Paviour D, Falup-Pecurariu C, Kessel B, Silverdale M, Todorova A, Sauerbier A, Odin P, Antonini A, Martinez-Martin P; EUROPAR and the IPMDS Non Motor PD Study Group. King's Parkinson's disease pain scale, the first scale for pain in PD: An international validation. Mov Disord. 2015 Oct;30(12):1623-31. doi: 10.1002/mds.26270. Epub 2015 Jun 11.
Cloninger CR. Temperament and personality. Curr Opin Neurobiol. 1994 Apr;4(2):266-73. doi: 10.1016/0959-4388(94)90083-3.
Costes N, Merlet I, Zimmer L, Lavenne F, Cinotti L, Delforge J, Luxen A, Pujol JF, Le Bars D. Modeling [18 F]MPPF positron emission tomography kinetics for the determination of 5-hydroxytryptamine(1A) receptor concentration with multiinjection. J Cereb Blood Flow Metab. 2002 Jun;22(6):753-65. doi: 10.1097/00004647-200206000-00014.
Dellapina E, Gerdelat-Mas A, Ory-Magne F, Pourcel L, Galitzky M, Calvas F, Simonetta-Moreau M, Thalamas C, Payoux P, Brefel-Courbon C. Apomorphine effect on pain threshold in Parkinson's disease: a clinical and positron emission tomography study. Mov Disord. 2011 Jan;26(1):153-7. doi: 10.1002/mds.23406. Epub 2010 Oct 19.
Dellapina E, Pellaprat J, Adel D, Llido J, Harroch E, Martini JB, Kas A, Salabert AS, Ory-Magne F, Payoux P, Brefel-Courbon C. Dopaminergic denervation using [123I]-FPCIT and pain in Parkinson's disease: a correlation study. J Neural Transm (Vienna). 2019 Mar;126(3):279-287. doi: 10.1007/s00702-019-01974-5. Epub 2019 Jan 31.
Defazio G, Berardelli A, Fabbrini G, Martino D, Fincati E, Fiaschi A, Moretto G, Abbruzzese G, Marchese R, Bonuccelli U, Del Dotto P, Barone P, De Vivo E, Albanese A, Antonini A, Canesi M, Lopiano L, Zibetti M, Nappi G, Martignoni E, Lamberti P, Tinazzi M. Pain as a nonmotor symptom of Parkinson disease: evidence from a case-control study. Arch Neurol. 2008 Sep;65(9):1191-4. doi: 10.1001/archneurol.2008.2.
Other Identifiers
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2022-501123-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RC31/21/0566
Identifier Type: -
Identifier Source: org_study_id
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