Evolution of RBD in PD

Parkinson's Disease Clinical Trial

Official title:

Evolution of REM Sleep Behavior Disorder in Parkinson's Disease Patients RBD Diagnosed Three Years Earlier

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03047408
• Other study ID #: CHU-300
• Secondary ID: 2016-A01736-45
• Status: Not yet recruiting
• Phase: N/A
• First received: January 24, 2017
• Last updated: February 6, 2017
• Start date: February 2017
• Est. completion date: June 2019

Study information

• Verified date: February 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 0473751195
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

About 60% of Parkinson's Disease (PD) patients have REM sleep Behavior Disorder (RBD), a parasomnia characterized by partial or complete loss of REM sleep muscle atonia and dream-enacting behaviors, usually associated to vivid dreams. The REM Sleep without atonia is the polysomnographic hallmark of RBD, and its quantification is necessary for the diagnosis.

RBD in PD is believed to be a marker of a more widespread degenerative process and a marker of malignant phenotype. Therefore, PD patients with RBD (PD-RBD) are more severely impaired in both motor and non-motor domains, compared to those without RBD, with an increased risk of dementia. However, little is know about the relationship between the evolution of RBD, clinic and video-polysomnographic, and the progression of PD. Besides, an improvement of RBD symptoms is anecdotally reported in PD patients over time. Longitudinal evaluation of RBD in PD, assessed by questionnaires, led to controversial results, but so far, no longitudinal vPSG study has been performed in PD-RBD population.

Thus, the main objective of this study is to longitudinally evaluate clinical and video-polysomnographic features of RBD, including measure of REM Sleep without atonia, in patients with PD-RBD, after three years from the diagnosis of RBD, in order to ascertain whether RBD features remain stable over time. The possible remission of RBD with the progression of PD would question indeed its reliability as prognostic bio-marker.

Description:

Type of study: longitudinal study, interventional, cross-sectional;

Number of centres: 1 (Clermont-Ferrand)

Patients: patients with Parkinson's Disease associated with REM sleep behavior disorder (PD-RBD) having already underwent video-polysomnography recording, clinical and neuropsychological evaluation in clinical setting or in the study "RBHP 2013 DURIF " at least three years ago.

Study performance:

This study will be developed in two phases:

• Phase 1 (Day 0):

• Verify inclusion criteria, receive informed and written consent;

• Demographic and clinical characteristics;

• Neurological evaluation: RBD (RBD severity scale), motor symptoms (Unified Parkinson's Disease Rating Scale, Hoeh et Yahr scale), orthostatic hypotension (Scale for outcomes in PD autonomic questionnaire), behavioral disorders hyper-dopaminergic and hypo-dopaminergic (Ardouin Scale of Behavior in Parkinson's Disease), impulsivity (Test Kirby and Stop signal reaction time)

• Dreams contents: all patients will receive 3-weeks dream diary;

• vPSG recording;

• Self-assessment questionnaires: Non-motor symptoms Questionnaire, Epworth sleepiness scale, Urgency premeditation perseverance and sensation seeking test, Aggressive questionnaire, and the Hospital Anxiety and Depression Rating Scale

• Phase 2 (+1day): Neuropsychological assessment of:

• Cognitive function, namely executive functions, visuo-spatial functions, visuo-perceptive functions (Mini mental state examination, California Verbal Learning Test, verbal fluency test, Modified Wisconsin Card Sorting Test, test de Stroop, Digit span, Visual Object and Space Perception Battery, Luria motor sequences, Rey-Osterrieth complex figure)

• Limbic functions: emotion recognition (Ekman test), apathy (Lille Apathy Rating Scale);

• Impulsivity and decision-making (Iowa Gambling test).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with clinically confirmed idiopathic Parkinson's Disease, according to the United Kingdom Parkinson Disease Bran Bank criteria, associated with RBD, diagnosed according to the International Classification of Sleep Disorders third edition, that have been already enrolled in the study "RBHP 2013 DURIF", or that have already underwent vPSG recording,clinical and neuropsychiatric evaluation in clinical setting;

• Male and female aged between 45 to 85 years old;

• All patients are volunteers and have given written informed consent;

• All patients are able to understand and to perform all tests included in this protocol;

• User-friendly in French language, both oral and written

Exclusion Criteria:

• Patients with neurological diseases other than PD;

• Patients with psychiatric comorbidities (hallucinations, psychosis) according to the DSM-5.

• Patients with Obstructive Sleep Apnea Syndrome (Apnea/hypopnea index >15/h);

• Patients in guardianship or tutorship;

• Patients enrolled exclusively in another study.

Related Conditions & MeSH terms

• Mental Disorders
• Parkinson Disease
• Parkinson's Disease
• REM Sleep Behavior Disorder

Intervention

Procedure:
• Video polysomnography
the main objective of our study is to longitudinally evaluate clinical and vPSG features of RBD, including measure of RSWA, in patients with PD-RBD, after three years from the diagnosis of RBD, in order to ascertain whether RBD features remain stable over time. The possible remission of RBD with the progression of PD would question indeed its reliability as prognostic bio-marker.

Locations

Country	Name	City	State
France	Chu Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of REM sleep Behavior Disorder confirmed during the video polysomnography		at day 0
Secondary	The REM sleep Behavior Disorder severity measured by the REM sleep Behavior Disorder scale		at day 0
Secondary	The Unified Parkinson disease Rating scale score		at day 0
Secondary	The behavioral disorders measured by the Ardouin Scale of Behavior in Parkinson's Disease score		at day 0
Secondary	- The Orthostatic hypotension measured by the Scale for outcomes in PD- autonomic questionnaire		at day 0
Secondary	The impulsivity measured by the Test of Kirby score		at day 0
Secondary	The impulsivity measured by the Stop signal reaction time score		at day 0
Secondary	The Hoehn and Yahr scale score		at day 0
Secondary	The Non-motor symptoms Questionnaire score		at day 0
Secondary	The Epworth sleepiness scale score		at day 0
Secondary	The Urgency premeditation perseverance and sensation seeking test		at day 0
Secondary	The Aggressive questionnaire score		at day 0
Secondary	The Hospital Anxiety and Depression Rating Scale		at day 0
Secondary	The dream content		at day 0
Secondary	The Mini mental state examination score		at day 1
Secondary	The California Verbal Learning Test score		at day 1
Secondary	The fluency verbal test score		at day 1
Secondary	The Modified Wisconsin Card Sorting Test		at day 1
Secondary	The Stroop score		at day 1
Secondary	The Empan test score		at day 1
Secondary	The Visual Object and Space Perception Battery test score		at day 1
Secondary	The Luria motor sequences		at day 1
Secondary	The Rey-Osterrieth complex figure		at day 1
Secondary	The Lille Apathy Rating Scale score		at day 1
Secondary	The Iowa Gambling test score		at day 1