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Parkinson's DiseasePREDI-STIMNCT02360683

Predictive Factors and Subthalamic Stimulation in Parkinson's Disease

An observational study of Parkinson's Disease, run by University Hospital, Lille at 15 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Parkinson's Disease
What is being tested?
patients with Parkinson's disease
How many people
700 participants
Where
15 sitesFrance
Study dates
18 Nov 2013to 10 Oct 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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 .

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • CHU Hôpital NORD

    Amiens

  • Hôpital Pierre Wertheimer

    Bron

  • Chu Gabriel-Montpied

    Clermont-Ferrand

  • Devos

    Lille, 59037

  • Hôpital de la Timone

    Marseille

  • Hôpital Central,

    Nancy

  • CHU hôpital Nord Laennec

    Nantes

  • Hôpital Pasteur

    Nice

  • Fondation Ophtalmologique Adolphe de Rothschild

    Paris

  • Hopital Pitie Salpetriere

    Paris

  • CHU de Poitiers

    Poitiers

  • CHU Hôpital Pontchaillou

    Rennes

  • Chu Ch.Nicolle

    Rouen

  • Hôpital de Hautepierre

    Strasbourg

  • CHU Purpan

    Toulouse

Other trials in France

About this study

Official title: Predictive Factors for Therapeutic Response of Subthalamic Stimulation on Quality of Live in Parkinson's Disease

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 .

Being tested
patients with Parkinson's disease
Keywords
Subthalamic neurostimulation
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • patients with Parkinson's diseaseOther

    Also called systematic and standardized collection of data

Study groups in NCT02360683
Study groupRoleWhat they receive
patients with Parkinson's diseaseLarge population of Parkinson's patients who benefit from subthalamic stimulation
Receives: Other: patients with Parkinson's disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improve of quality of life on PDQ39>20%

    Measured: 1 year

Secondary outcomes (9)

  1. Percentage of motor score MDS-UPDRS III improve under stimulation

    Measured: 1 year

  2. Socio-familial evolution (institutionalization)

    Measured: 1, 3 and 5 years

  3. Clinical Global Impression of Patient by 7-point scale

    with the CGI-scale

    Measured: 1, 3 and 5 years

  4. Clinical Global Impression of doctor by 7-point scale

    with the CGI-scale

    Measured: 1, 3 and 5 years

  5. Death

    Measured: 1, 3 and 5 years

  6. 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

    Measured: 1, 3 and 5 years

  7. 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

    Measured: 1, 3 and 5 years

  8. 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

    Measured: 1, 3 and 5 years

  9. Non-motor functions evaluated by a numerical evaluation scale

    Measured: screening and at 1, 3 and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2015 (estimated)
  2. Study start18 Nov 2013
  3. Primary completion10 Oct 2025
  4. Study completion10 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02360683
Sponsor's protocol ID
2011_41
Other IDs
2013-A00193-42
Acronym
PREDI-STIM
Status last verified
Nov 2022
First submitted
5 Jan 2015
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33022101

  • 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.

    PubMed 42035924

  • 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.

    PubMed 40302158

  • 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.

    PubMed 38908172

  • 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.

    PubMed 38272656

  • 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.

    PubMed 38189764

  • 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.

    PubMed 36030666

  • 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.

    PubMed 34667082

  • 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.

    PubMed 33526820

  • 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.

    PubMed 33411732

  • 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.

    PubMed 32444557

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease, run by University Hospital, Lille at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improve of quality of life on PDQ39>20% (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02360683, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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