Assessing gray matter volume in patients with idiopathic rapid eye movement sleep behavior disorder
| ISRCTN | ISRCTN18238599 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18238599 |
| Protocol serial number | 1.0 |
| Sponsor | Huashan Hospital, Fudan University |
| Funders | China-US Biomedical Collaborative Research Program, No. 81361120393, National Natural Science Foundation of China, No. 81401135, 81671239, Shanghai Sailing Program, No. 18YF1403100. |
- Submission date
- 11/10/2018
- Registration date
- 24/10/2018
- Last edited
- 31/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Idiopathic rapid eye movement (REM) sleep behavior disorder (iRBD) is a parasomnia, which is unusual nervous system activity during sleep. iRBD presents as limb movements, which often appear to act out the content of undesirable dreams. Patients and relatives complain about iRBD symptoms such as shouting, gesturing, leaping out of bed, or punching bed partners. iRBD is receiving increased attention as an important risk factor for the future development of neurodegenerative disorders, such as Parkinson’s disease (PD). The cause remains unclear in iRBD patients. iRBD development is likely to stem from abnormalities in the structure of the brain. The development of imaging technology provides a new way to study such diseases, including functional and structural imaging. Functional imaging studies have reported that iRBD patients have regional cerebral perfusion and glucose metabolic changes. We aim to detect the changes in the structure of the brain, and find structural changes related to clinical indices in patients with iRBD. Our study’s findings should provide more structural evidence for cerebral functional changes in this population.
Who can participate?
Adults who are diagnosed with iRBD at the Sleep and Wake Disorders Center in China
What does the study involve?
Patients will undertake the overnight polysomnographic (PSG) recordings. Only those patients who meet the clinical and PSG diagnosis criteria for iRBD can join this study. Patients will also receive a neurological examination and undertake various questionnaires. Besides, patients should receive the neurologic examination, Unified Parkinson’s Disease Rating Scale motor rating (UPDRS III) and Mini-Mental State Examination (MMSE) score. All participants will also undertake high-resolution, structural MRI scans.
What are the possible benefits and risks of participating?
This study can expand the spectrum of reported structural changes in iRBD patients, having implications for the future research about such disease. In this study, iRBD patients can obtain the latest information about the progression of their disease, with no radiation. Based on the clinical and imaging data, patients may regulate therapeutic plans to produce a better curative effect. There will be no immediate direct risk to those taking part. The main discomfort of taking MRI is loud noise during the scans.
Where is the study run from?
Sleep and Wake Disorders Center of the Department of Neurology and Radiology Department of Huashan Hospital, Fudan University (China)
When is the study starting and how long is it expected to run for?
January 2014 to December 2015
Who is funding the study?
1. China-US Biomedical Collaborative Research Program (USA, China)
2. National Natural Science Foundation of China (China)
3. Shanghai Sailing Program (China)
Who is the main contact?
Dr Xian-Hua Han
xhhan_2015@126.com
Contact information
Public
No.12, Urumqi Middle Road, Jing'an District
Shanghai
200040
China
| Phone | +86 (0)15802117087 |
|---|---|
| xhhan_2015@126.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross-sectional study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Exploring cerebral structural alterations using MRI and determining their association with clinical parameters in Idiopathic rapid eye movement sleep behavior disorder (iRBD) patients |
| Study objectives | To investigate the gray matter volume (GMV) changes, and the relationships between GMV and clinical indices, in iRBD patients. |
| Ethics approval(s) | The Ethics Committee of Huashan Hospital, 04/01/2014, ref: KY2013-336 |
| Health condition(s) or problem(s) studied | Idiopathic rapid eye movement sleep behavior disorder |
| Intervention | All iRBD patients underwent one night (8 hours) of audio-video-PSG monitoring. All MRI measurements were obtained on a 3-tesla GE Discovery MR750 Scanner for ~30minutes. Brain structural T1-weighted MRI scans was acquired from all 39 participants. Gray matter volume (GMV) data were analyzed based on Statistical Parametric Mapping 8, using a voxel-based morphometry method and two-sample t-test and multiple regression analysis. No follow-up data were obtained due to the nature of study design. |
| Intervention type | Other |
| Primary outcome measure(s) |
Gray matter volume, assessed by MRI scans for 30 minutes at the study visit |
| Key secondary outcome measure(s) |
Polysomnography monitoring over one night for 8 hours to assess: |
| Completion date | 10/12/2015 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 39 |
| Key inclusion criteria | 1. Aged 18–65 years 2. Diagnosed with iRBD according to the clinical and polysomnographic (PSG) characteristics |
| Key exclusion criteria | 1. Signs of parkinsonism 2. Treated with psychotropic medications 3. Evidence of psychiatric disorders or dementia 4. Any cognitive impairment 5. Drug-induced iRBD 6. Sleep apnea syndrome 7. Electroencephalograph (EEG) abnormalities suggestive of epilepsy, central nervous system comorbidities such as brain tumor, encephalitis, unstable hypertension, and diabetes |
| Date of first enrolment | 06/03/2014 |
| Date of final enrolment | 08/04/2015 |
Locations
Countries of recruitment
- China
Study participating centre
Shanghai
200040
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Individual participant data that underlie the results reported in this article will be published in a peer-reviewed journal, after deidentification (text, tables, figures, and appendices). It will be available to researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to zuoct_cn2000@126.com. To gain access, data requestors will need to sign a data access agreement. The study protocol, statistical analysis plan and informed consent form will also be available from 3 months up to 5 years following article publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2019 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
31/01/2019: Publication reference added.
02/11/2018: Internal review.
