Predictive Factors and Subthalamic Stimulation in Parkinson's Disease

NCT02360683 | Completed DMC

• 2 other identifiers: 2011_412013-A00193-42
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 15

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 .

Conditions

Parkinson's Disease

Keywords

Subthalamic neurostimulation

Outcome Measures

Primary Outcomes (1)

• Improve of quality of life on PDQ39>20%

  1 year

Secondary Outcomes (9)

• 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

  1, 3 and 5 years

• Clinical Global Impression of doctor by 7-point scale

  1, 3 and 5 years

• Death

  1, 3 and 5 years

Study Arms (1)

patients with Parkinson's disease

Large population of Parkinson's patients who benefit from subthalamic stimulation

Other: patients with Parkinson's disease

Interventions

patients with Parkinson's disease OTHER

Also known as: systematic and standardized collection of data

patients with Parkinson's disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Multicentric French cohort of 1000 Parkinson's disease patients, for obtain 400 patients in the failure group

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (15)

CHU Hôpital NORD

Amiens, France

Location

Hôpital Pierre Wertheimer

Bron, France

Location

Chu Gabriel-Montpied

Clermont-Ferrand, France

Location

Devos

Lille, 59037, France

Location

Hôpital de la Timone

Marseille, France

Location

Hôpital Central,

Nancy, France

Location

CHU hôpital Nord Laennec

Nantes, France

Location

Hôpital Pasteur

Nice, France

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, France

Location

Hopital Pitie Salpetriere

Paris, France

Location

CHU de Poitiers

Poitiers, France

Location

CHU Hôpital Pontchaillou

Rennes, France

Location

Chu Ch.Nicolle

Rouen, France

Location

Hôpital de Hautepierre

Strasbourg, France

Location

CHU Purpan

Toulouse, France

Location

Related Publications (9)

• 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.

  PMID: 33022101 RESULT

• 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.

  PMID: 40302158 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.

  PMID: 38908172 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.

  PMID: 38189764 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.

  PMID: 36030666 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.

  PMID: 34667082 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.

  PMID: 33526820 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.

  PMID: 33411732 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.

  PMID: 32444557 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• David DEVOS, MD, PhD

  University Hospital, Lille

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: February 10, 2015
• Study Start: November 18, 2013
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: April 22, 2026

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)