Clinical trial NCT04608123: Effect of Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease
Official title: Effect of Bilateral Subthalamic Nucleus Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease, Evaluated With a New, Dedicated Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease (Disorder)
Keywords: DBS
Deep Brain Stimulation
Neuropsychiatric Fluctuations
Nonmotor Fluctuations
Scale
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PD patients treated with DBS STN at Grenoble Hospital within September 2016 and June 2019

Brief summary: 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: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of DBS for Neuropsychiatric Fluctuations
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Preoperative and Postoperative demographical and clinical factors linked to a post-surgical change in Neuropsychiatric Fluctuations
timeFrame: 12 months
measure: Neuropsychiatric Fluctuations, Cognitive and Psychiatric state
timeFrame: 12 months
measure: Neuropsychiatric Fluctuations, preoperative and postoperative motor status
timeFrame: 12 months
measure: Neuropsychiatric Fluctuations and other Nonmotor Symptoms
timeFrame: 12 months
measure: Neuropsychiatric Fluctuations and Dopaminergic Therapy
timeFrame: 12 Months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital, Grenoble
state: Isère
Study officials:
affiliation: University Hospital, Grenoble
name: Elena Moro
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.