Pain Assessment in Patients With Idiopathic REM Sleep Behaviour Disorder (PAIN-iRBD)

Toulouse University Hospital

Status: Not yet enrolling

Conditions: REM Sleep Behavior Disorder (iRBD); Narcolepsy Type 1

Treatments: Other: No motors symptoms evaluations; Other: Pain questionnaires; Other: Thermo test pain

Study type: Interventional

Funder types: Other

Identifiers

NCT07365566

ID-RCB (Other Identifier)

RC31/25/0567

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Idiopathic REM sleep Behavior disorder (iRBD) Group

Experimental group

Description:

Patients who have an idiopathic REM sleep Behavior Disorder

Treatment:

Other: Thermo test pain

Other: No motors symptoms evaluations

Other: Pain questionnaires

Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1

Active Comparator group

Description:

patients who have an iRBD and who have type 1 narcolepsy

Treatment:

Other: Thermo test pain

Other: No motors symptoms evaluations

Other: Pain questionnaires