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

Completed

• Conditions: Parkinson's Disease (Disorder)
• Interventions: Other: none (observational study)

• Registration Number: NCT04608123
• Lead Sponsor: University Hospital, Grenoble

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)

Study Timeline

• Study Start: 2020-05-01
• Status Verified: 2020-07
• Primary Completion: 2020-07-21
• Study Completion: 2020-07-21
• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-29
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DBS Patients with NFS	none (observational study)	Patients with PD treated with STN DBS between 2016 and 2019 who underwent NFS testing in pre and post-op conditions

Primary Outcome Measures

Name	Time	Method
Effectiveness of DBS for Neuropsychiatric Fluctuations	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

Secondary Outcome Measures

Name	Time	Method
Neuropsychiatric Fluctuations and other Nonmotor Symptoms	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)
Neuropsychiatric Fluctuations and Dopaminergic Therapy	12 Months	Changing in pre-postop NFS scores correlated with: - Preoperative versus postoperative Levodopa equivalent dose (LEDD)
Preoperative and Postoperative demographical and clinical factors linked to a post-surgical change in Neuropsychiatric Fluctuations	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)
Neuropsychiatric Fluctuations, Cognitive and Psychiatric state	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)
Neuropsychiatric Fluctuations, preoperative and postoperative motor status	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

Trial Locations

Locations (1)

University Hospital, Grenoble; 🇫🇷 Grenoble, Isère, France