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

October 29, 2020 updated by: University Hospital, Grenoble

Effect of Bilateral Subthalamic Nucleus Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease, Evaluated With a New, Dedicated Scale

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Isère
      • Grenoble, Isère, France, 38000
        • University Hospital, Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
DBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of DBS for Neuropsychiatric Fluctuations
Time Frame: 12 months after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative and Postoperative demographical and clinical factors linked to a post-surgical change in Neuropsychiatric Fluctuations
Time Frame: 12 months

Changing in pre-post op NFS scores correlated with:

  • Demographic and Clinical data: age, sex, disease duration, side onset, clinical phenotype, years passed with fluctuations, comorbidities, psychiatric history not linked to the disease or its treatment, psychiatric complications of dopaminergic therapy
  • Dopaminergic treatment data: years of therapy with Levodopa, percentage of motor improvement with Levodopa-test, pre and postoperative LEDD, changing in psychiatric treatment (doses and number of medications)
  • Perioperative variables: type of anaesthesia, perioperative complications
  • DBS parameters: stimulation type, plots selected, amplitude, rate, duration of impulse, stereo tactical coordinates of electrodes, stimulator type (rechargeable, not rechargeable)
12 months
Neuropsychiatric Fluctuations, Cognitive and Psychiatric state
Time Frame: 12 months

Changing in pre-postop NFS scores correlated with:

  • Cognitive evaluation scales (Mattis Scale, Score Frontal, Wisconsin Card Sorting Test - WCST, Luria manual sequencing task)
  • Psychiatric evaluation scales (Beck Depression Scale - BDI-II, Evaluation Comportamentale dans la Maladie de Parkinson - ECMP, Starkstein Apathy Scale)
12 months
Neuropsychiatric Fluctuations, preoperative and postoperative motor status
Time Frame: 12 months

Changing in pre-postop NFS scores correlated with:

  • Preoperative UPDRS III Score (total score, sub scores of tremor, rigidity, akinesia, parole, posture-gait-instability) in MED ON and MED OFF conditions
  • Changing in UPDRS III Scores (total and sub scores) in preoperative MED ON and MED OFF conditions versus postoperative MED ON STIM ON and MED OFF STIM ON conditions
12 months
Neuropsychiatric Fluctuations and other Nonmotor Symptoms
Time Frame: 12 months

Changing in pre-postop NFS scores correlated with:

- Changing in MDS-UPDRS scores and sub scores (total, section I, section II, section IV)
12 months
Neuropsychiatric Fluctuations and Dopaminergic Therapy
Time Frame: 12 Months

Changing in pre-postop NFS scores correlated with:

- Preoperative versus postoperative Levodopa equivalent dose (LEDD)
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Study Director: Elena Moro, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

July 21, 2020

Study Completion (Actual)

July 21, 2020

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Actual)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Other Grant/Funding Number: Community Foundation of Greater Birmingham Women's Breast Health Fund

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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