Genetic inactivation of glutamate neurons in the rat sublaterodorsal tegmental nucleus recapitulates REM sleep behaviour disorder.
Sara Valencia Garcia, Paul-Antoine Libourel, Michael Lazarus...
https://pubmed.ncbi.nlm.nih.gov/28007991Actively Recruiting
Phase 4
Age: 40Years - 85Years
All Genders
Healthy Volunteers
ID06710574
Multimodal Image Technologies Investigate the Role and Mechanism of Probiotics in Improving Rapid Eye Movement Behavior Disorder with Parkinson's Disease
Led by Beijing Friendship Hospital · Updated on 2024-12-02
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how probiotics might improve rapid eye movement sleep behavior disorder (RBD), a non-movement symptom and risk factor of Parkinson's disease (PD). This study focuses on patients with PD-related RBD, idiopathic RBD, and healthy controls, using advanced imaging and clinical assessments to understand the effects and mechanisms of probiotic treatment on RBD and PD motor symptoms. Participants receive probiotic treatments involving Bifidobacterium triple viable capsules and Bacillus licheniformis capsules. Some groups maintain their original anti-Parkinson's medications while taking probiotics. The study includes monitoring before and after treatment using multimodal imaging techniques like resting-state functional MRI, proton magnetic resonance spectroscopy, and 123I-MIBG cardiac scintigraphy, along with clinical symptom scales and microbiota analysis. During the 12-week study, participants undergo evaluations including clinical scales for movement and sleep behavior, polysomnography for sleep disorders, blood and stool tests for metabolites and bacteria abundance, and multiple imaging scans. Researchers analyze these data to explore probiotic impact on brain structure, function, and gut microbiota. Safety and symptom changes are monitored throughout, with the trial concluding after the treatment and assessment period.
CONDITIONS
Brief Title
Multimodal Image Technologies Investigate the Role and Mechanism of Probiotics in Improving RBD with Parkinson's Disease
Who Can Participate
Age: 40Years - 85Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age between 40 and 80 years, male or female
- Diagnosis of idiopathic Parkinson's disease meeting MDS criteria (2015)
- Modified Hoehn and Yahr stage of Parkinson's disease less than or equal to stage 3
- Mini-Mental State Examination (MMSE) score greater than 24
- No depression or anxiety, with Hamilton Depression Scale score less than 9 and Anxiety Scale score less than 14
- RBD screening questionnaire score greater than 5 with diagnosis confirmed by polysomnography and exclusion of obstructive sleep apnea
- Stable Parkinson's disease motor and RBD symptoms with no medication adjustments in the prior month
- Discontinued benzodiazepines such as clonazepam and melatonin at least one month prior
- No use of probiotics, prebiotics, or antibiotics in the two months prior to enrollment
- Willingness to comply with study protocol and sign informed consent
- For idiopathic RBD patients, same age and mental health criteria apply
- Healthy controls matched for age and sex, with RBD screening score less than or equal to 5, no dementia, depression, anxiety, or severe constipation, and no recent use of probiotics, prebiotics, or antibiotics
You will not qualify if you...
- Parkinsonism plus syndromes or secondary parkinsonism including multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia degeneration, dementia with Lewy bodies, vascular parkinsonism, or post-encephalitis parkinsonism
- Use of probiotics, prebiotics, or antibiotics within 2 months prior to enrollment
- Adjustment of Parkinson's disease medication within 1 month prior to enrollment
- Use of benzodiazepines such as clonazepam or melatonin within 1 month prior to enrollment
- Presence of Alzheimer's disease, malignant tumors, spinal cord lesions, epilepsy, autonomic nerve diseases, or recent cerebrovascular events affecting assessment
- Anxiety or depression requiring medication
- Severe cardiovascular diseases such as congestive heart failure class II-III or recent myocardial infarction
- Severe liver or kidney dysfunction with lab values exceeding 1.5 times normal limits
- Pregnant or lactating women or women aged 40-60 with positive pregnancy test
- Known allergy to study probiotic capsules or their excipients
- History of drug abuse or alcohol dependence
- Participation in another clinical trial at enrollment
- Refusal or inability to cooperate with study procedures or judged ineligible by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive probiotic capsules and continue their original Parkinson's disease medications if applicable, to evaluate the effect of probiotics on improving REM sleep behavior disorder and Parkinson's disease symptoms.
Regular visits for clinical assessment and sample collection during the 12-week treatment period
Follow-up
Duration - Post 12-week treatment period until study completion
Participants undergo imaging, clinical assessments, and laboratory tests post-treatment to evaluate changes in brain structure, function, gut microbiota abundance, and symptom improvement.
Visits for imaging and laboratory tests after treatment completion
Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital, Capital Medical University
Beijing, China, 100050
Actively Recruiting
Loading map...
Research Team
H
Houzhen Tuo Principal Investigator, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
A53T-α-synuclein overexpression in murine locus coeruleus induces Parkinson's disease-like pathology in neurons and glia.
Martin Timo Henrich, Fanni Fruzsina Geibl, Bolam Lee...
https://pubmed.ncbi.nlm.nih.gov/29747690In-vivo staging of pathology in REM sleep behaviour disorder: a multimodality imaging case-control study.
Karoline Knudsen, Tatyana D Fedorova, Allan K Hansen...
https://pubmed.ncbi.nlm.nih.gov/29866443Magnetic Resonance Imaging Biomarkers to Assess Substantia Nigra Damage in Idiopathic Rapid Eye Movement Sleep Behavior Disorder.
Nadya Pyatigorskaya, Rahul Gaurav, Dario Arnaldi...
https://pubmed.ncbi.nlm.nih.gov/28958075Ictal SPECT in patients with rapid eye movement sleep behaviour disorder.
Geert Mayer, Marion Bitterlich, Torsten Kuwert...
https://pubmed.ncbi.nlm.nih.gov/25732183Abnormal Gray Matter Shape, Thickness, and Volume in the Motor Cortico-Subcortical Loop in Idiopathic Rapid Eye Movement Sleep Behavior Disorder: Association with Clinical and Motor Features.
Shady Rahayel, Ronald B Postuma, Jacques Montplaisir...
https://pubmed.ncbi.nlm.nih.gov/28591814Loss of dorsolateral nigral hyperintensity on 3.0 tesla susceptibility-weighted imaging in idiopathic rapid eye movement sleep behavior disorder.
Roberto De Marzi, Klaus Seppi, Birgit Högl...
https://pubmed.ncbi.nlm.nih.gov/27016314Basal ganglia dysfunction in idiopathic REM sleep behaviour disorder parallels that in early Parkinson's disease.
Michal Rolinski, Ludovica Griffanti, Paola Piccini...
https://pubmed.ncbi.nlm.nih.gov/27297241Jouvet's animal model of RBD, clinical RBD, and their relationships to REM sleep mechanisms.
Pierre-Hervé Luppi
https://pubmed.ncbi.nlm.nih.gov/30172630Microbiome, inflammation, epigenetic alterations, and mental diseases.
Reza Alam, Hamid M Abdolmaleky, Jin-Rong Zhou
https://pubmed.ncbi.nlm.nih.gov/28691768