Pain Assessment in Patients With Idiopathic Rapid Eye Movement (REM) Sleep Behaviour Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thermo test pain, Pain questionnaires, No motors symptoms evaluations.
- Who it may be relevant to
- Registry conditions: REM Sleep Behavior Disorder (iRBD), Narcolepsy Type 1. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pain Assessment in Patients With Idiopathic REM Sleep Behaviour Disorder
Overview
Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease, with over 12 million patients expected globally by 2040. The disease is currently diagnosed at the appearance of motor symptoms, but by then, over 60% of striatal dopaminergic neurons have already been destroyed. Prodromal symptoms such as idiopathic REM Sleep Behavior Disorder (iRBD), anosmia, mood disorders and constipation appear earlier and are listed as criteria for a prodromal PD diagnosis. Identifying early signs is critical to initiate neuroprotective treatments as early as possible. While pain is prevalent and highly disabling in early PD, no data are currently available on pain perception in iRBD patients, whose condition is of the main risk factor for PD development.
Interventions
- Other Thermo test pain
Patients will undergo a pain test, also called a thermotest, which consists of determining pain thresholds using a thermometer applied to the hand. - Other Pain questionnaires
Patients will complete various questionnaires about pain - Other No motors symptoms evaluations
Patients will complete questionnaires
Primary outcome measures
- Comparison of the intensity of chronic pain between patients with iRBD and a control group of patients [Time frame: 2 hours after the inclusion]
Secondary outcome measures (5)
- Describe semiological characteristics of pain in RBD patients [Time frame: 2 hours after the inclusion]
- Compare the presence of chronic pain [Time frame: 2 hours after the inclusion]
- Assessing Pain Characteristics [Time frame: 2 hours after the inclusion]
- Assessment of thermal pain threshold and tolerance [Time frame: 2 hours after the inclusion]
- Assessment of correlations between the intensity of chronic pain [Time frame: 2 hours after the inclusion]
Eligibility criteria
Inclusion criteria
- Diagnosed with iRBD confirmed by polysomnography;
- No clinical diagnosis of Parkinson's disease or other diagnosis of neurodegenerative disease;
- Ability to understand and complete study procedures and questionnaires;
Control group:
- Diagnosed with narcolepsy type 1;
- Coexisting REM sleep behavior disorder confirmed by polysomnography;
- Ability to understand and complete study procedures and questionnaires;
Exclusion criteria
- Diagnosed Parkinson's Disease, dementia with Lewy bodies or multiple system atrophy;
- Severe depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM V);
- Inability to complete study procedures or questionnaires.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Centre Expert Parkinson Hôpital Pierre Paul Riquet Place du Docteur Baylac — Toulouse
Identifiers
NCT: NCT07365566 · RC31/25/0567 · ID-RCB