Ultra-HIGH-D: Ultra- High field ImaGing in Huntington´s Disease
Recruiting
To determine early and subtle MRI changes in premanifest and early manifest HD patients which distinguish them from the healthy population. This includes both structural/quantitative MRI data and MRI-signs of blood-brain barrier (BBB) breakdown. And also to lay the foundation for a longitudinal cohort study that allows to investigate the prognostic implications of these MRI changes.
Furthermore, to investigate if gadolinium(MRI contrast agent), injected during MRI, enters tear fluid and to investigate if the level of gadolinium correlates with the level of BBB leakage on MRI.
All participants will be assessed only once. However, patients will be asked for the consent to be contacted about follow-up studies.
Subtype: Observational Biomarker
Primary Purpose: Diagnostic
Ages Eligible
for Study:
Sexes Eligible
for Study:
All
Accepts Healthy Volunteers:
yes
General inclusion criterium:
– Between 18 years and 75 years of age
Inclusion criteria pre-manifest participants:
– An UHDRS motor score <= 5
– CAG repeat size of 36 or more
*
Inclusion criteria manifest participants:
– An UHDRS motor score > 5
– Disease Stage 1 or 2
– CAG repeat size of 36 or more
– TFC between 7 and 13 (disease stage 1 or 2)
Inclusion Criteria gene negative controls
– a CAG repeat size of 35 or less
– Subjects with contra-indications for a MRI-scan as defined in the MRI
screening form of SCANNEXUS such as claustrophobia, subjects carrying
incompatible metallic devices, subjects who have an allergy for intravenous
contract or subjects who are pregnant.
– Manifest participants who are not capable of consenting
– Manifest patients not capable of undergoing MRI because of involuntary
movements.
– Genotype unknown
– Current participation in a drug trial
– Not agreeing to be informed about incidental findings on the MRI scan
– Known kidney insufficiency
LOCATION
NETHERLANDS
TRIAL SITE: Medisch Universitair Ziekenhuis Maastricht
P. Debeyelaan 25, Maastricht 6229HX, NL
