7T-RBD
Sponsor study identifier
observational
100
1 country
1
Study Start
February 1, 2026
Actual (reported)Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Comprehensive characterization of early-stage Parkinson's disease in patients with REM sleep behavior disorder Parkinson's disease (PD) is the fastest-growing neurodegenerative disorder worldwide, significantly affecting quality of life and causing substantial social and economic burdens. Currently, treatments for Parkinson's disease primarily manage symptoms through medication and lifestyle changes but cannot stop disease progression. By the time Parkinson's disease is diagnosed, substantial nerve-cell loss has already occurred in specific brain areas. Identifying early signs of PD before symptoms fully develop is essential for improving future treatment strategies. This research project aims to deeply understand the earliest stages of Parkinson's disease by studying patients with REM sleep behavior disorder (RBD). RBD is a condition characterized by unusual movements or behaviors during dream sleep, caused by nerve-cell loss in the brainstem. Importantly, more than 80% of individuals with RBD eventually develop Parkinson's disease or related conditions, such as Dementia with Lewy Bodies or Multiple System Atrophy. Study Goals: Our study will examine multiple potential biomarkers (measurable indicators) that could help identify early stages of Parkinson's disease. These include:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2026
Actual (reported)March 20, 2026
Actual (reported)August 27, 2026
Actual (reported)June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Structural disintegraiton of the Locus Coeruleus
One of the main hypotheses is that there will be a strutural pattern of disintegration in the Locus Coeruleus (LC) in our RBD-cohort when compared to controls. This will be seen as a change in neuromelanin Contrast-to-Noise-Ratio (CNR) in the LC. We expect this pattern to have a caudo-rostral gradient, as other studies have shown in subjects with Parkinson's Disease.
Baseline
Differences in neuromelanin-CNR in the Substantia Nigra pars Compacta in RBD-subjects compared to controls
As with the Locus Coeruleus, it is expected to see altered neuromelanin signal from the SNc in RBD subjects compared to controls
Baseline
Control participants without known major psychiatric or neurological disease.
Subjects diagnosed with RBD via polysomnography.
We have 2 groups; Subjects diagnosed with REM-sleep behaviour disorder via polysomnography Healthy, age- and gendermatched controls. Our RBD-group will be recruited via an ongoing cohort at a different site (Danish center for sleep medicine), where subjects diagnosed with RBD via polysomnography will be asked to also participate in our cohort, should they fulfill our inclusion criteria. Controls will be recruited via our own institutions webpage, as well as advertisements on other danish websites such as trialtree.dk.
Danish Research Centre for Magnetic Resonance
Hvidovre, 2650, Denmark
Miglis MG, Zitser J, Schneider L, During E, Jaradeh S, Freeman R, Gibbons CH. Cutaneous alpha-synuclein is correlated with autonomic impairment in isolated rapid eye movement sleep behavior disorder. Sleep. 2021 Dec 10;44(12):zsab172. doi: 10.1093/sleep/zsab172.
Doppler K, Jentschke HM, Schulmeyer L, Vadasz D, Janzen A, Luster M, Hoffken H, Mayer G, Brumberg J, Booij J, Musacchio T, Klebe S, Sittig-Wiegand E, Volkmann J, Sommer C, Oertel WH. Dermal phospho-alpha-synuclein deposits confirm REM sleep behaviour disorder as prodromal Parkinson's disease. Acta Neuropathol. 2017 Apr;133(4):535-545. doi: 10.1007/s00401-017-1684-z. Epub 2017 Feb 8.
Blood and skin samples testing for the occurence of alfa-synuclein pathology
First Submitted
March 20, 2026
First Posted
August 27, 2026
Study Start
February 1, 2026
Actual (reported)Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Motor-task performance
Baseline
Cognitive test performance
Baseline
Resting-state EEG
Baseline
Correlation between LC and autonomic dysfunction.
Baseline
Autonomic, sympathic responses to arousing stimuli
Baseline
Longitudinal outcomes
Through study completion, an average of 1 year
Longitudinal outcomes
Through study completion, an average of 1 year
Longitudinal outcomes
Through study completion, an average of 1 year
Contact the study team to confirm eligibility.
Sakakibara R, Tateno F, Aiba Y, Ogata T, Kishi M, Terada H, Inaoka T, Nakatsuka T, Matsuoka K. MIBG Myocardial Scintigraphy Identifies Premotor PD/DLB During a Negative DAT Scan Period: Second Report. Mov Disord Clin Pract. 2018 Nov 9;6(1):46-50. doi: 10.1002/mdc3.12697. eCollection 2019 Jan.
Pitton Rissardo J, Fornari Caprara AL. Cardiac 123I-Metaiodobenzylguanidine (MIBG) Scintigraphy in Parkinson's Disease: A Comprehensive Review. Brain Sci. 2023 Oct 18;13(10):1471. doi: 10.3390/brainsci13101471.
Borghammer P, Van Den Berge N. Brain-First versus Gut-First Parkinson's Disease: A Hypothesis. J Parkinsons Dis. 2019;9(s2):S281-S295. doi: 10.3233/JPD-191721.
Madelung CF, Lokkegaard A, Fuglsang SA, Marques MM, Boer VO, Madsen KH, Hejl AM, Meder D, Siebner HR. High-resolution mapping of substantia nigra in Parkinson's disease using 7 tesla magnetic resonance imaging. NPJ Parkinsons Dis. 2025 May 6;11(1):113. doi: 10.1038/s41531-025-00972-7.
Madelung CF, Meder D, Fuglsang SA, Marques MM, Boer VO, Madsen KH, Petersen ET, Hejl AM, Lokkegaard A, Siebner HR. Locus Coeruleus Shows a Spatial Pattern of Structural Disintegration in Parkinson's Disease. Mov Disord. 2022 Mar;37(3):479-489. doi: 10.1002/mds.28945. Epub 2022 Feb 3.
Study Completion
December 31, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 27, 2026
Record last verified: 2026-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: