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Pain Assessment in Patients With Idiopathic Rapid Eye Movement (REM) Sleep Behaviour Disorder

N/ARecruitingNCT07365566
University Hospital, Toulouse24 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

24

Conditions

REM Sleep Behavior Disorder (iRBD)Narcolepsy Type 1

Interventions

Thermo test painOTHER

Patients will undergo a pain test, also called a thermotest, which consists of determining pain thresholds using a thermometer applied to the hand.

Pain questionnairesOTHER

Patients will complete various questionnaires about pain

No motors symptoms evaluationsOTHER

Patients will complete questionnaires

Eligibility

Sex: ALLMin age: 18 Years
Medical Language ↔ Plain English
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.

Locations (1)

Centre Expert Parkinson Hôpital Pierre Paul Riquet Place du Docteur Baylac

Toulouse, France

RECRUITING

Outcomes

Primary Outcomes

Comparison of the intensity of chronic pain between patients with iRBD and a control group of patients

Measuring the Visual Analog Scale (VAS) between patients with iRBD without diagnosis of PD and a control group of patients diagnosed with narcolepsy type 1 who present RBD (Rapid eye movement sleep behavior disorder).

Time frame: 2 hours after the inclusion

Secondary Outcomes

Describe semiological characteristics of pain in RBD patients

Description of characteristics of pain

Time frame: 2 hours after the inclusion

Compare the presence of chronic pain

Number of patients with chronic pain in both groups for at least 3 months.

Time frame: 2 hours after the inclusion

Assessing Pain Characteristics

Score obtained on pain questionnaires

Time frame: 2 hours after the inclusion

Assessment of thermal pain threshold and tolerance

Results of the quantitative sensory test (thermal thermotest) in both groups

Time frame: 2 hours after the inclusion

Assessment of correlations between the intensity of chronic pain

Correlation between Visual Analogue Scale (VAS) measurements and questionnaire responses

Time frame: 2 hours after the inclusion

Central Contacts

Christine BREFEL COURBON

CONTACT

05 61 77 60 39christine.brefel-courbon@univ-tlse3.Fr
Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.