Ultra- High field ImaGing in Huntington*s Disease

Ultra- High field ImaGing in Huntington*s Disease - Ultra-HIGH-D

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54262

Enrollment

Registered

2022-07-18

Start date

2023-09-05

Completion date

Unknown

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autosomal dominant neurodegenerative disease Huntington's chorea

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: General inclusion criterium: - Between 18 years and 75 years of age Inclusion criteria pre-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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
- The main study endpoint will be the structural and functional changes of the premanifest compared to early manifest and healthy family or gene negative controls, which will be assessed on 7T ultra-high field MR images. We will also use quantitative MRI approaches, since this enables us to detect small structural and anatomical differences which cannot be detected on qualitative MRI acquisitions. - BBB permeability as determined by DCE-MRI to assess the leakiness of the cerebral vasculature by dynamically measuring the rate of contrast agent transfer from blood into the interstitial space (leakage rate; units: ml.min 1.100g). We will compare BBB permeability in early manifest HD with pre-manifest HD participants.	—

Measure

Time frame

- The main study endpoint will be the structural and functional changes of the premanifest compared to early manifest and healthy family or gene negative controls, which will be assessed on 7T ultra-high field MR images. We will also use quantitative MRI approaches, since this enables us to detect small structural and anatomical differences which cannot be detected on qualitative MRI acquisitions. - BBB permeability as determined by DCE-MRI to assess the leakiness of the cerebral vasculature by dynamically measuring the rate of contrast agent transfer from blood into the interstitial space (leakage rate; units: ml.min 1.100g). We will compare BBB permeability in early manifest HD with pre-manifest HD participants.

—

Secondary

Measure	Time frame
We will assess the relationship between the imaging measures and clinical scores/ disease burden with regression analysis. We will investigate if gadolinium, injected during MRI, enters tear fluid. We will investigate if the level of gadolinium correlates with the level of BBB leakage on MRI.	—

Countries

Netherlands

Outcome results