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

ConditionsREM Sleep Behavior Disorder (iRBD)Narcolepsy Type 1
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Diagnosed with narcolepsy type 1;

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Thermo test pain

    Other intervention

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

  • Pain questionnaires

    Other intervention

    Patients will complete various questionnaires about pain

  • No motors symptoms evaluations

    Other intervention

    Patients will complete questionnaires

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Idiopathic REM sleep Behavior disorder (iRBD) GroupExperimental treatment 3 interventions
Group B: Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

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

1

Describe semiological characteristics of pain in RBD patients

Description of characteristics of pain

Time frame
2 hours after the inclusion
2

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
3

Assessing Pain Characteristics

Score obtained on pain questionnaires

Time frame
2 hours after the inclusion
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Toulouse

Lead sponsor

Source ClinicalTrials.gov
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