Predictive Factors and Subthalamic Stimulation in Parkinson's Disease
NCT ID: NCT02360683
Last Updated: 2022-11-07
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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ACTIVE_NOT_RECRUITING
700 participants
OBSERVATIONAL
2013-11-18
2025-11-30
Brief Summary
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The investigators want to identify factors that predict the improvement of quality of life for one year corresponding to a decrease of PDQ39 score of at least 20 %. They believe that improvement would be less likely to become zero to 3 or 5 years and question the indication of the subthalamic stimulation (risks and costs). This is part of a process of "personalization" of the therapeutic care that is of any interest to the subthalamic stimulation. It is a therapeutic option that could be dangerous if patient selection is not optimal , and expensive, if the benefit is not large enough to reduce the number of medications and hospitalizations medium term . In addition, it will quantify the improvement of quality of life in the longer term and harmonize national assessments .
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients with Parkinson's disease
Large population of Parkinson's patients who benefit from subthalamic stimulation
patients with Parkinson's disease
Interventions
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patients with Parkinson's disease
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Bilateral STN stimulation considered
* Patient able to provide their free and informed consent
* Patient with insurance coverage
Exclusion Criteria
* MP under 5 years
* Severe cognitive impairment or dementia ( Score Moca \<24 and DSM-IV criteria)
* Parkinson's Psychosis
* Reply to L- dopa \<30 %
* Against indication for surgery
* Severe brain atrophy or abnormal MRI
* The presence of another very serious condition terminal life- short-term prognosis ( malignancy ) is an indication against .
18 Years
75 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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David DEVOS, MD, PhD
Role: STUDY_CHAIR
University Hospital, Lille
Locations
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CHU Hôpital NORD
Amiens, , France
Hôpital Pierre Wertheimer
Bron, , France
Chu Gabriel-Montpied
Clermont-Ferrand, , France
Devos
Lille, , France
Hôpital de la Timone
Marseille, , France
Hôpital Central,
Nancy, , France
CHU hôpital Nord Laennec
Nantes, , France
Hôpital Pasteur
Nice, , France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, , France
Hopital Pitie Salpetriere
Paris, , France
CHU de Poitiers
Poitiers, , France
CHU Hôpital Pontchaillou
Rennes, , France
Chu Ch.Nicolle
Rouen, , France
Hôpital de Hautepierre
Strasbourg, , France
CHU Purpan
Toulouse, , France
Countries
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References
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Ollivier T, Pinto S, Rolland AS, Cailliau E, Touzet G, Thobois S, Eusebio A, Hainque E, Rouaud T, Drapier S, Guehl D, Maltete D, Anheim M, Lagha Boukbiza O, Giordana C, Tir M, Hopes L, Hubsch C, Jarraya B, Marques A, Brefel C, Rascol O, Corvol JC, Benatru I, Defebvre L, Devos D, Moreau C; French PREDISTIM study group. Parkinson's Disease, Speech and Neurosurgery. Brain Behav. 2025 May;15(5):e70101. doi: 10.1002/brb3.70101.
Meyer M, Spitz E, Colnat-Coulbois S, Benatru I, Guehl D, Hainque E, Rolland AS, Corvol JC, Devilliers H, Schwan R, Devos D; PREDISTIM group. Development and validation of the DBS-PS (Deep Brain Stimulation-Perception Scale): Assessing parkinsonian patients' expectations to prevent post-operative disappointment? J Neurol Sci. 2024 Jul 15;462:123093. doi: 10.1016/j.jns.2024.123093. Epub 2024 Jun 13.
Rolland AS, Touzet G, Carriere N, Mutez E, Kreisler A, Simonin C, Kuchcinski G, Chalhoub N, Pruvo JP, Defebvre L, Reyns N, Devos D, Moreau C. The Use of Image Guided Programming to Improve Deep Brain Stimulation Workflows with Directional Leads in Parkinson's Disease. J Parkinsons Dis. 2024;14(1):111-119. doi: 10.3233/JPD-225126.
Boussac M, Arbus C, Colin O, Laurencin C, Eusebio A, Hainque E, Corvol JC, Versace N, Rascol O, Rousseau V, Harroch E, Ory-Magne F, Fabbri M, Moreau C, Rolland AS, Jarraya B, Maltete D, Drapier S, Marques AR, Auzou N, Wirth T, Meyer M, Giordana B, Tir M, Rouaud T, Devos D, Brefel-Courbon C; PREDISTIM study group. Personality assessment with Temperament and Character Inventory in Parkinson's disease. Parkinsonism Relat Disord. 2022 Oct;103:34-41. doi: 10.1016/j.parkreldis.2022.08.004. Epub 2022 Aug 19.
Besse-Pinot E, Pereira B, Durif F, Fantini ML, Durand E, Debilly B, Derost P, Moreau C, Hainque E, Rouaud T, Eusebio A, Benatru I, Drapier S, Guehl D, Rascol O, Maltete D, Lagha-Boukbiza O, Giordana C, Tir M, Thobois S, Hopes L, Hubsch C, Jarraya B, Rolland AS, Corvol JC, Devos D, Marques A; Predistim Study Group. Preoperative REM Sleep Behavior Disorder and Subthalamic Nucleus Deep Brain Stimulation Outcome in Parkinson Disease 1 Year After Surgery. Neurology. 2021 Nov 16;97(20):e1994-e2006. doi: 10.1212/WNL.0000000000012862. Epub 2021 Oct 19.
Betrouni N, Moreau C, Rolland AS, Carriere N, Chupin M, Kuchcinski G, Lopes R, Viard R, Defebvre L, Devos D. Texture-based markers from structural imaging correlate with motor handicap in Parkinson's disease. Sci Rep. 2021 Feb 1;11(1):2724. doi: 10.1038/s41598-021-81209-4.
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.
Santin MDN, Voulleminot P, Vrillon A, Hainque E, Bereau M, Lagha-Boukbiza O, Wirth T, Montaut S, Bardinet E, Kyheng M, Rolland AS, Voirin J, Drapier S, Durif F, Eusebio A, Giordana C, Auzou N, Houeto JL, Hubsch C, Jarraya B, Laurencin C, Maltete D, Meyer M, Rascol O, Rouaud T, Tir M, Moreau C, Corvol JC, Proust F, Grabli D, Devos D, Tranchant C, Anheim M; Predistim Study Group. Impact of Subthalamic Deep Brain Stimulation on Impulse Control Disorders in Parkinson's Disease: A Prospective Study. Mov Disord. 2021 Mar;36(3):750-757. doi: 10.1002/mds.28320. Epub 2020 Oct 6.
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.
Other Identifiers
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2013-A00193-42
Identifier Type: OTHER
Identifier Source: secondary_id
2011_41
Identifier Type: -
Identifier Source: org_study_id
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