Magnetic 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/28958075/Actively Recruiting
Led by Beijing Friendship Hospital · Updated on 2024-12-02
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are investigating how probiotics might improve rapid eye movement sleep behavior disorder RBD, a non-movement symptom and risk factor of Parkinsons 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-Parkinsons 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
Multimodal Image Technologies Investigate the Role and Mechanism of Probiotics in Improving RBD with Parkinson's Disease
H
Houzhen Tuo Principal Investigator, PhD
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Beijing Friendship Hospital
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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