Neural Correlates of Impulsivity in Idiopathic REM Sleep Behavior Disorder

An observational study of Parkinson Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial 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… Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Parkinson Disease
How many people: 96 participants
Where: 1 siteHong Kong
Study dates: 1 Jan 2022to 31 Dec 2024
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site, 1 recruiting

The Chinese University of Hong Kong
Hong Kong
Mandy Yu, MPH, 852-39197593, mandyyu@cuhk.edu.hk
Rachel Chan, PhD, 852-39197449, Rachel.chan@cuhk.edu.hk
Recruiting

Other trials in Hong Kong

About this study

Official title: Neural Correlates of Impulsivity in Idiopathic REM Sleep Behavior Disorder: a Functional Magnetic Resonance Imaging Case-control Study

Read the detailed description

Background: Excessive impulsivity is an important non-motor symptom of Parkinson's disease (PD), especially for those on dopamine agonist treatment. Dopaminergic dysfunction has been highly correlated with impulsivity. Given that idiopathic REM sleep behavior disorder (iRBD) is a prodromal stage of alpha-synucleinopathy, such as PD, the dysfunction of dopaminergic system at this early stage may also precipitate alternation of impulsivity.

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: Parkinson Disease
Being tested: No intervention
Keywords: Impulsivity, Prodromal Parkinson's disease, REM sleep behavior disorder, Functional Magnetic Resonance Image
Medical subject headings: Parkinson Disease, Impulsive Behavior, REM Sleep Behavior Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No interventionOther
No intervention

Study groups in NCT05353855
Study group	Role	What they receive
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) Receives: 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. Receives: 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. Receives: 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. Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Brain activity
To access different cognitive aspects in neurobehavioral impulsivity such as BART, TCIP and SKIP between groups
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202231 Dec 2024

First posted29 Apr 2022
Study start1 Jan 2022
Primary completion30 Nov 2024 (estimated)
Study completion31 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 96 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05353855
Sponsor's protocol ID: HMRF08191416
Status last verified: Apr 2024
First submitted: 13 Jan 2022
Last updated: 19 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Data will be handled and stored under Department of Psychiatry and PI will be responsible for the safekeeping.

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neural Correlates of Impulsivity in Idiopathic REM Sleep Behavior Disorder: a Functional Magnetic Resonance Imaging Case-control Study
ClinicalTrials.gov ID: NCT05353855
Acronym / sponsor ID: HMRF08191416
Conditions: Parkinson Disease
Keywords: Impulsivity, Prodromal Parkinson's disease, REM sleep behavior disorder, Functional Magnetic Resonance Image
Study type: Observational
Recruitment status: Unknown status
Enrolment: 96 participants (estimated)
Lead sponsor: Chinese University of Hong KongUniversity, hospital or other
Study start: 1 Jan 2022 (actual)
Primary completion: 30 Nov 2024 (estimated)
Study completion: 31 Dec 2024 (estimated)
First posted: 29 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 4

Arm	Type	Receives
Early unmedicated PD patients converted from iRBD	–	Other: No intervention1. 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)
Early medicated PD patients converted from iRBD	–	Other: No interventionInclusion criteria will be the same as that of early unmedicated PD except that they should be on dopaminergic medications.
iRBD patients	–	Other: No intervention1. 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.
Healthy controls	–	Other: No intervention1. 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.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No interventionNo intervention	Other	Early medicated PD patients converted from iRBD, Early unmedicated PD patients converted from iRBD, Healthy controls, iRBD patients

Primary outcome

Brain activity
Time frame: 1 year
To access different cognitive aspects in neurobehavioral impulsivity such as BART, TCIP and SKIP between groups

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
Individual participant dataSharing planned: Undecided. Data will be handled and stored under Department of Psychiatry and PI will be responsible for the safekeeping.

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Enrolling by invitationObservational study
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RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The Chinese University of Hong Kong

Hong Kong, Hong Kong

852-39197593

mandyyu@cuhk.edu.hk

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain activity (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05353855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.