A novel test (RT-QuIC) to differentiate between two types of REM Behavioural Disorder (RBD) - pRBD (which is a potential indicator of future development of Parkinson's Disease) and iRBD (which is not thought to be)

Establishing alpha-synuclein Real Time - Quaking Induced Conversion (RT-QuIC) assay as a diagnostic technique in REM sleep behaviour disorder (RBD)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN32474552

Enrollment

125

Registered

2020-02-06

Start date

2021-10-01

Completion date

Unknown

Last updated

2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

REM behavioural disorder and Parkinson's disease Mental and Behavioural Disorders

Interventions

This is a cross-sectional, multi-centre study using the CSF of patients with RBD which may or may not develop into a neurodegenerative disease, as well as patients with RBD who have already developed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of RBD based on International Classification of Sleep Disorders 3rd Edition (ICSD-3) criteria 2. Aged 18 years or over 3. Willing and able to give written informed consent and comply with protocol

Exclusion criteria

Exclusion criteria: 1. RBD secondary to medication or withdrawal state 2. <18 years old 3. Unwilling or unable to give written informed consent or comply with protocol 4. Contraindication to lumbar puncture procedure (e.g. patients taking Warfarin)

Design outcomes

Primary

Measure	Time frame
Positive/negative (binary) result from the a-syn RT-QuIC assay. A positive output confirms the presence of pathological a-synuclein within the CSF. Measured using lumbar puncture to obtain CSF at a single trial visit.	—

Secondary

Measure	Time frame
All measures will take place at the patient's only trial visit: 1. Screening for co-morbidities using a medical history questionnaire 2. Screening for REM Behavioural disorder with the RBDQ-HK questionnaire 3. Excessive daytime sleepiness assessed using the Epworth Sleepiness Scale 4. Sleep pattern assessed using a sleep diary 5. Stressful events that might cause illnesses assessed using the Holmes and Rahe stress scale 6. Orthostatic hypotension assessed using the Orthostatic Standing Test 7. Clinical rating scale for Parkinson's disease using the MDS-UPDRS questionnaire 8. Venepuncture to obtain 9 ml of blood for future genetic testing in follow-up study	—

Measure

Time frame

All measures will take place at the patient's only trial visit: 1. Screening for co-morbidities using a medical history questionnaire 2. Screening for REM Behavioural disorder with the RBDQ-HK questionnaire 3. Excessive daytime sleepiness assessed using the Epworth Sleepiness Scale 4. Sleep pattern assessed using a sleep diary 5. Stressful events that might cause illnesses assessed using the Holmes and Rahe stress scale 6. Orthostatic hypotension assessed using the Orthostatic Standing Test 7. Clinical rating scale for Parkinson's disease using the MDS-UPDRS questionnaire 8. Venepuncture to obtain 9 ml of blood for future genetic testing in follow-up study

—

Countries

Scotland, United Kingdom

Contacts

Public ContactSteven Williams

picklish@hotmail.com+44 (0)7903029892

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026