Neural Correlates of Impulsivity in Idiopathic REM Sleep Behavior Disorder
NCT ID: NCT05353855
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
96 participants
OBSERVATIONAL
2022-01-01
2024-12-31
Brief Summary
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Detailed Description
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Hypothesis and objectives: iRBD may have altered impulsivity which is similar to that found in de novo PD and may serve as a biomarker in differentiating iRBD from healthy controls. 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.
Design and subjects: This is a case-control study that will recruit 96 subjects (24 healthy controls, 24 patients with iRBD, 24 PD patients on dopaminergic medication and 24 PD patients who are not on dopaminergic medication).
Main outcome measures: 1) The difference in brain activity in response to impulsivity tasks between groups; 2) The difference in structure volume, structural and functional connectivity of region of interest related to impulsivity (prefrontal cortex and basal ganglia) between groups; 3) The association of these changes with the stage of disease from healthy, to prodromal, and to clinically diagnosed PD.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
No intervention
No intervention
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)
No intervention
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.
No intervention
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.
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
2. Presence of narcolepsy or other neurodegenerative diseases (except for PD group) that may give rise to RBD;
3. Presence of mood disorder which may have great impact on impulsivity;
4. A total score of the Montreal Cognitive Assessment (MOCA) ≤ 22 and the Clinical Dementia Rating (CDR) ≥ 1, indicating dementia;
5. 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;
6. Contraindication to MRI (e.g., presence of implants or claustrophobia).
50 Years
ALL
Yes
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Professor Wing Yun Kwok
Professor
Locations
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The Chinese University of Hong Kong
Hong Kong, , Hong Kong
Countries
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Facility Contacts
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Other Identifiers
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HMRF08191416
Identifier Type: -
Identifier Source: org_study_id
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