Clinical Trial: Evolution of RBD in PD

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.


Detailed Summary:

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 functi
    Sponsor: University Hospital, Clermont-Ferrand

    Current Primary Outcome: presence of REM sleep Behavior Disorder confirmed during the video polysomnography [ Time Frame: at day 0 ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

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


    Original Secondary Outcome: Same as current

    Information By: University Hospital, Clermont-Ferrand

    Dates:
    Date Received: January 24, 2017
    Date Started: February 2017
    Date Completion: June 2019
    Last Updated: February 6, 2017
    Last Verified: February 2017