NCT04608123

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
Last Updated

November 2, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

October 22, 2020

Last Update Submit

October 29, 2020

Conditions

Parkinson's Disease (Disorder)

Keywords

DBSDeep Brain StimulationNeuropsychiatric FluctuationsNonmotor FluctuationsScale

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of DBS for Neuropsychiatric Fluctuations

    Improvement of Neuropsychiatric Fluctuation Scale (NFS) Score between preoperative MED ON and MED OFF conditions versus postoperative MED ON-STIM ON and MED OFF-STIM ON conditions. NFS ON and OFF med scores are independent and they ranges from -30 to +30. Positive scores represent good outcomes (good feelings, non OFF neuropsychiatric symptoms), whereas negative scores denote the presence of negative feelings in a quantity exceeding the positive ones

    12 months after surgery

Secondary Outcomes (5)

  • Preoperative and Postoperative demographical and clinical factors linked to a post-surgical change in Neuropsychiatric Fluctuations

    12 months

  • Neuropsychiatric Fluctuations, Cognitive and Psychiatric state

    12 months

  • Neuropsychiatric Fluctuations, preoperative and postoperative motor status

    12 months

  • Neuropsychiatric Fluctuations and other Nonmotor Symptoms

    12 months

  • Neuropsychiatric Fluctuations and Dopaminergic Therapy

    12 Months

Study Arms (1)

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

Other: none (observational study)

Interventions

none (observational study)OTHER

DBS

DBS Patients with NFS

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PD patients treated with DBS STN at Grenoble Hospital within September 2016 and June 2019

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Grenoble

Grenoble, Isère, 38000, France

Location

Related Publications (5)

  • 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.

    PMID: 30363450RESULT

  • 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.

    PMID: 29436490RESULT

  • 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.

    PMID: 28805564RESULT

  • 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.

    PMID: 28725706RESULT

  • 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.

    PMID: 23263599RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Elena Moro

    University Hospital, Grenoble

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 29, 2020

Study Start

May 1, 2020

Primary Completion

July 21, 2020

Study Completion

July 21, 2020

Last Updated

November 2, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)