Clinical trial NCT02360683: Predictive Factors and Subthalamic Stimulation in Parkinson's Disease
Official title: Predictive Factors for Therapeutic Response of Subthalamic Stimulation on Quality of Live in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Parkinson's Disease
Keywords: Subthalamic neurostimulation
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2015-02-10
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Multicentric French cohort of 1000 Parkinson's disease patients, for obtain 400 patients in the failure group

Brief summary: 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 .


Eligibility criteria: Inclusion Criteria:

* Patients receiving a pre- therapeutic assessment and therapeutic monitoring for one year , 3 years and 5 years as part of the regular monitoring of the subthalamic stimulation
* Bilateral STN stimulation considered
* Patient able to provide their free and informed consent
* Patient with insurance coverage

Exclusion Criteria:

* Atypical Parkinson's disease do not meet the criteria of stuff .
* 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 .

Primary outcomes:
measure: Improve of quality of life on PDQ39>20%
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of motor score MDS-UPDRS III improve under stimulation
timeFrame: 1 year
measure: Socio-familial evolution (institutionalization)
timeFrame: 1, 3 and 5 years
measure: Clinical Global Impression of Patient by 7-point scale
timeFrame: 1, 3 and 5 years
measure: Clinical Global Impression of doctor by 7-point scale
timeFrame: 1, 3 and 5 years
measure: Death
timeFrame: 1, 3 and 5 years
measure: Cognitive function with a neuropsychological examination
timeFrame: 1, 3 and 5 years
measure: Behavior test
timeFrame: 1, 3 and 5 years
measure: Motor response rates to Levodopa
timeFrame: 1, 3 and 5 years
measure: Non-motor functions evaluated by a numerical evaluation scale
timeFrame: screening and at 1, 3 and 5 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Hôpital NORD
city: Bron
country: France
facility: Hôpital Pierre Wertheimer
city: Clermont-Ferrand
country: France
facility: Chu Gabriel-Montpied
city: Lille
country: France
facility: Devos
city: Marseille
country: France
facility: Hôpital de la Timone
city: Nancy
country: France
facility: Hôpital Central,
city: Nantes
country: France
facility: CHU hôpital Nord Laennec
city: Nice
country: France
facility: Hôpital Pasteur
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: CHU Hôpital Pontchaillou
city: Rouen
country: France
facility: Chu Ch.Nicolle
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Toulouse
country: France
facility: CHU Purpan
Study officials:
affiliation: University Hospital, Lille
name: David DEVOS, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.