Neural Correlates of Impulsivity in Idiopathic REM Sleep Behavior Disorder

NCT05353855 | Recruiting DMC

• 1 other identifier: HMRF08191416
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the neural correlates (structural changes, functional connectivity, and structural connectivity of brain structures in prefrontal cortex and basal ganglia) of impulsivity by measuring structures and the blood-oxygen-level-dependent signal of brain in response to impulsive tasks and task-free using functional Magnetic Resonance Image method among healthy controls, patient with prodromal PD (iRBD), and patients with PD.

Conditions

Parkinson Disease

Keywords

Impulsivity; Prodromal Parkinson's disease; REM sleep behavior disorder; Functional Magnetic Resonance Image

Outcome Measures

Primary Outcomes (1)

• Brain activity

  To access different cognitive aspects in neurobehavioral impulsivity such as BART, TCIP and SKIP between groups

  1 year

Study Arms (4)

Early unmedicated PD patients converted from iRBD

1. Chinese aged 50 or above; 2. Being capable of giving informed consent for participation of the study; 3. Having a diagnosis of PD confirmed by neurologists according to the United Kingdom Parkinson's Disease Survey Brain Bank. 4. Onset of PD motor symptoms of \< 3 years; 5. In view of the heterogeneity of PD, the investigator will only include those patients with RBD preceding the onset of motor symptoms of PD. 6. Drug naïve (dopaminergic medications have not been started)

Other: No intervention

Early medicated PD patients converted from iRBD

Inclusion criteria will be the same as that of early unmedicated PD except that they should be on dopaminergic medications.

Other: No intervention

iRBD patients

1. Chinese aged 50 or above; 2. Being capable of giving informed consent for participation of the study; 3. Having a diagnosis of RBD according to the International classification of sleep disorder 3rd edition (ICSD 3rd), fulfilling both the clinical and video-polysomnography (vPSG) criteria.

Other: No intervention

Healthy controls

1. Age-and sex-matched with the groups; 2. Being capable of giving informed consent for participation of the study; 3. Without a personal history or a family history of PD or RBD; 4. A total score on REM Sleep Behavior Questionnaire (RBDQ-HK) less than 19, which is the suggestive cut-off of a diagnosis of RBD; 5. Absence of self-report dream enactment behaviors and RSWA as measured by v-PSG.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Early medicated PD patients converted from iRBD; Early unmedicated PD patients converted from iRBD; Healthy controls; iRBD patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a case-control study. We plan to recruit four groups of participants: patients with PD on/are not on dopaminergic medication converted from iRBD, patients with iRBD, and healthy control group.

You may qualify if:

• Age-and sex-matched with the groups;
• Being capable of giving informed consent for participation of the study;
• Without a personal history or a family history of PD or RBD;
• A total score on REM Sleep Behavior Questionnaire (RBDQ-HK) less than 19, which is the suggestive cut-off of a diagnosis of RBD;
• Absence of self-report dream enactment behaviors and RSWA as measured by v-PSG

You may not qualify if:

• Having a history of ICD diagnosis or ICD symptom(s) assessed with Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS);
• Presence of narcolepsy or other neurodegenerative diseases (except for PD group) that may give rise to RBD;
• Presence of mood disorder which may have great impact on impulsivity;
• A total score of the Montreal Cognitive Assessment (MOCA) ≤ 22 and the Clinical Dementia Rating (CDR) ≥ 1, indicating dementia;
• Except for early medicated PD patients, if subjects from other groups who are on medication that may induce impulsivity, such as dopaminergic medication, will be excluded;
• Contraindication to MRI (e.g., presence of implants or claustrophobia).

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Impulsive Behavior; REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: April 29, 2022
• Study Start: January 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

HK (1)