Imaging Neuromelanin and Iron in Dystonia/Parkinsonism
2 other identifiers
observational
80
0 countries
N/A
Brief Summary
To generate pilot data to investigate the potential to use in vivo iron- and neuromelanin-quantification as imaging tools for the diagnostic evaluation of movement disorders with predominant dystonia / parkinsonism. To this end we are planning to compare the MR imaging neuromelanin and iron-pattern and content in midbrain, striatum and further brain structures in clinically similar entities and respective, sex- and age-matched healthy controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2018
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2018
CompletedFirst Posted
Study publicly available on registry
June 28, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedJune 28, 2018
June 1, 2018
3 years
February 8, 2018
June 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
neuromelanin content
absolute amount of neuromelanin in midbrain, striatum and other areas of the brain
up to 8 weeks
Secondary Outcomes (3)
neuromelanin association
up to 8 weeks
iron association
up to 8 weeks
Iron content
up to 8 weeks
Study Arms (6)
Sporadic Dystonia
3 Tesla MRI Burke-Fahn-Marsden Dystonia Rating scale MDS-United Parkinsons Disease Rating Scale, Part III Beck Depression Inventory MoCA: Montreal Cognitive Assessment
Familial Dystonia
3 Tesla MRI Burke-Fahn-Marsden Dystonia Rating scale MDS-United Parkinsons Disease Rating Scale, Part III Beck Depression Inventory MoCA: Montreal Cognitive Assessment
Parkinson´s disease, juvenile
3 Tesla MRI Burke-Fahn-Marsden Dystonia Rating scale MDS-United Parkinsons Disease Rating Scale, Part III Beck Depression Inventory MoCA: Montreal Cognitive Assessment
Neurodegeneration with brain iron acc.
3 Tesla MRI Burke-Fahn-Marsden Dystonia Rating scale MDS-United Parkinsons Disease Rating Scale, Part III Beck Depression Inventory MoCA: Montreal Cognitive Assessment
mitochondrial disease
3 Tesla MRI Burke-Fahn-Marsden Dystonia Rating scale MDS-United Parkinsons Disease Rating Scale, Part III Beck Depression Inventory MoCA: Montreal Cognitive Assessment
Healthy Controls
3 Tesla MRI Burke-Fahn-Marsden Dystonia Rating scale MDS-United Parkinsons Disease Rating Scale, Part III Beck Depression Inventory MoCA: Montreal Cognitive Assessment
Interventions
1. A previously validated multi-parameter mapping protocol sensitive to neuromelanin and iron content 2. Iron mapping and micro-bleed detection: QSM (quantitative susceptibility mapping), a fully flow-compensated, susceptibility-weighted gradient-echo sequence (5 minutes). 3. 1-mm isotropic anatomical MPRAGE (magnetization-prepared rapid gradient-echo) 4. conventional FLAIR sequence
internationally standardized examination/quantification of dystonia
most recent, internationally standardized examination/quantification of bradykinesia / rigidity according to the Movement Disorder Society
internationally standardized examination to quantify traits of anxiety and depression
internationally standardized examination to quantify cognition, frequently used in studies of dystonia and parkinsonism
Eligibility Criteria
Patients from the National Hospital of Neurology, Queen Square, movement disorder outpatient clinic;
You may qualify if:
- clinical diagnosis of parkinsonism and/or dystonia due to
- dopa-responsive dystonia
- sporadic or inherited/genetic dystonia
- young-onset Parkinson's disease
- NBIA
- Mitochondrial disease
- OR healthy controls
- to 60 years of age
- able to give informed consent
You may not qualify if:
- Inability to tolerate 35min in an MRI machine
- Contra-indications to 3T MRI on MRI safety grounds, such as presence of contra-indicated medical implants, as according to the established routine operating procedures for clinical MRI in the Lysholm Department of Neuroradiology at the National Hospital for Neurology and Neurosurgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bhatia P Kailash, MD, DM, FRCP
UCL, Institute of Neurology, Sobell Department
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2018
First Posted
June 28, 2018
Study Start
July 1, 2018
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
June 28, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share