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Effect of Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease

NCT ID: NCT04608123

Last Updated: 2020-11-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-07-21

Brief Summary

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Retrospective, monocentric, observational study designed to evaluate the effects of Bilateral Subthalamic Nucleus Deep Brain Stimulation (DBS STN) on Neuropsychiatric fluctuations in Patients with Parkinson's Disease (PD)

Detailed Description

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Pre-operative versus 12-Month Follow-Up analysis of changing in Neuropsychiatric Fluctuations Scale (NFS) score in preoperative versus postoperative MED OFF (during acute withdrawal of dopaminergic therapy) and MED ON (during super-liminal Levodopa dose) conditions. Postoperative evaluations are always performed with DBS turned on and stimulating (STIM ON)

Conditions

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Parkinson's Disease (Disorder)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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DBS Patients with NFS

Patients with PD treated with STN DBS between 2016 and 2019 who underwent NFS testing in pre and post-op conditions

none (observational study)

Intervention Type OTHER

DBS

Interventions

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none (observational study)

DBS

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Parkinson's disease
* Treatment with Bilateral STN DBS
* Evaluation with NFS in both preoperative and 12 months post-surgery follow-up context

Exclusion Criteria

* DBS for non PD patients
* Unilateral DBS or other DBS targets
* Patients not evaluated with NFS
* Patients with incomplete preoperative evaluation
* Patients who refused the use of their data
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elena Moro

Role: STUDY_DIRECTOR

University Hospital, Grenoble

Locations

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University Hospital, Grenoble

Grenoble, Isère, France

Site Status

Countries

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France

References

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Schmitt E, Krack P, Castrioto A, Klinger H, Bichon A, Lhommee E, Pelissier P, Fraix V, Thobois S, Moro E, Martinez-Martin P. The Neuropsychiatric Fluctuations Scale for Parkinson's Disease: A Pilot Study. Mov Disord Clin Pract. 2018 Mar 23;5(3):265-272. doi: 10.1002/mdc3.12607. eCollection 2018 May-Jun.

Reference Type RESULT
PMID: 30363450 (View on PubMed)

Abbes M, Lhommee E, Thobois S, Klinger H, Schmitt E, Bichon A, Castrioto A, Xie J, Fraix V, Kistner A, Pelissier P, Seigneuret E, Chabardes S, Mertens P, Broussolle E, Moro E, Krack P. Subthalamic stimulation and neuropsychiatric symptoms in Parkinson's disease: results from a long-term follow-up cohort study. J Neurol Neurosurg Psychiatry. 2018 Aug;89(8):836-843. doi: 10.1136/jnnp-2017-316373. Epub 2018 Feb 7.

Reference Type RESULT
PMID: 29436490 (View on PubMed)

Hogg E, Wertheimer J, Graner S, Tagliati M. Deep Brain Stimulation and Nonmotor Symptoms. Int Rev Neurobiol. 2017;134:1045-1089. doi: 10.1016/bs.irn.2017.05.022. Epub 2017 Jul 3.

Reference Type RESULT
PMID: 28805564 (View on PubMed)

Kurtis MM, Rajah T, Delgado LF, Dafsari HS. The effect of deep brain stimulation on the non-motor symptoms of Parkinson's disease: a critical review of the current evidence. NPJ Parkinsons Dis. 2017 Jan 12;3:16024. doi: 10.1038/npjparkd.2016.24. eCollection 2017.

Reference Type RESULT
PMID: 28725706 (View on PubMed)

Azulay JP, Witjas T, Eusebio A. Effect of subthalamic deep brain stimulation on non-motor fluctuations in Parkinson's disease. J Neural Transm (Vienna). 2013 Apr;120(4):655-7. doi: 10.1007/s00702-012-0958-9. Epub 2012 Dec 23.

Reference Type RESULT
PMID: 23263599 (View on PubMed)

Other Identifiers

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0

Identifier Type: -

Identifier Source: org_study_id