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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00193-42 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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This study identify preoperative predictors of response to subthalamic stimulation at 1 year, 3 years and 5 years in terms of quality of life, from a broad prospective multicenter study French with standardized collection of clinical data , imaging and genetic .
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with Parkinson's disease | Large population of Parkinson's patients who benefit from subthalamic stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patients with Parkinson's disease | Other |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Improve of quality of life on PDQ39>20% | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of motor score MDS-UPDRS III improve under stimulation | 1 year | |
| Socio-familial evolution (institutionalization) | 1, 3 and 5 years | |
| Clinical Global Impression of Patient by 7-point scale |
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Inclusion Criteria:
Exclusion Criteria:
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Multicentric French cohort of 1000 Parkinson's disease patients, for obtain 400 patients in the failure group
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| Name | Affiliation | Role |
|---|---|---|
| David DEVOS, MD, PhD | University Hospital, Lille | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Hôpital NORD | Amiens | France | ||||
| Hôpital Pierre Wertheimer |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33022101 | Result | 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. | |
| 42035924 |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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with the CGI-scale |
| 1, 3 and 5 years |
| Clinical Global Impression of doctor by 7-point scale | with the CGI-scale | 1, 3 and 5 years |
| Death | 1, 3 and 5 years |
| Cognitive function with a neuropsychological examination | with Mattis scale, Wisconsin Card Sorting test, Stroop test, , verbal episodic memory test with 16 items, phonemic and semantic verbal fluency, Boston naming test (15 items), clock drawing and Benton line orientation task | 1, 3 and 5 years |
| Behavior test | ECMP scale of Ardouin 2009, Hamilton depression scale, Anxiety Hamilton scale, Lille Apathy Rating Scale, QUIP questionnaire, Billieux Impulsivity Scale, Hallucination questionnaire of Miami | 1, 3 and 5 years |
| Motor response rates to Levodopa | with the difference of the motor handicap measured by MDS UPDRS part III before and after an acute L-dopa challenge | 1, 3 and 5 years |
| Non-motor functions evaluated by a numerical evaluation scale | screening and at 1, 3 and 5 years |
| Bron |
| France |
| Chu Gabriel-Montpied | Clermont-Ferrand | France |
| Devos | Lille | 59037 | 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 |
| Derived |
| Huin V, Cailliau E, Poupelin C, Garcon G, Dutheil M, Simonin O, Beauval N, Labreuche J, Blum D, Moreau C, Hainque E, Marques A, Eusebio A, Benatru I, Brefel-Courbon C, Maltete D, Giordana C, Tir M, Thobois S, Brandel JP, Jarraya B, Hopes L, Rascol O, Corvol JC, Devos D, Rolland AS; PREDISTIM study group. Blood-based biomarkers of ferroptosis in Parkinson's disease. Neurobiol Dis. 2026 Jun 15;224:107414. doi: 10.1016/j.nbd.2026.107414. Epub 2026 Apr 24. |
| 40302158 | Derived | 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. |
| 38908172 | Derived | 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. |
| 38272656 | Derived | Faggianelli F, Witjas T, Azulay JP, Benatru I, Hubsch C, Anheim M, Moreau C, Hainque E, Drapier S, Jarraya B, Laurencin C, Guehl D, Hopes L, Brefel-Courbon C, Tir M, Marques A, Rouaud T, Maltete D, Giordana C, Baumstarck K, Rascol O, Corvol JC, Rolland AS, Devos D, Eusebio A; PREDISTIM study group. ON/OFF non-motor evaluation: a new way to evaluate non-motor fluctuations in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2024 Jun 17;95(7):656-662. doi: 10.1136/jnnp-2023-332551. |
| 38189764 | Derived | 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. |
| 36030666 | Derived | 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. |
| 34667082 | Derived | 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. |
| 33526820 | Derived | 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. |
| 33411732 | Derived | 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. |
| 32444557 | Derived | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |