Early Biomarkers in Premanifest Huntington's Disease Gene Carriers: a Pilot Study

NCT06626308 | Recruiting

• 2 other identifiers: 38RC24.02132024-A01476-41
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate if new, early biomarkers of the disease are available in presymptomatic genetic carriers of Huntington\'s diesase compared to healthy subjects. The main questions it aims to answer are: Does functional brain MRI is able to detect early biomarkers of the disease in genetic carriers? Does gait study by a virtual reality device can detect early biomarkers of the disease in genetic carriers? Researchers will compare genetic carriers and healthy subjects to see if new, early biomarkers of the disease can be detected .

Conditions

Huntington Disease

Keywords

biomarkers; genetic carriers; brain functional MRI

Outcome Measures

Primary Outcomes (1)

• Brain functional MRI biomarker investigation

  Measurement of BOLD (Blood Oxygen Level Dependent) signal changes using fMRI (3 Tesla), in two subcortical regions, SC, LGN, and V1 in response to visual stimuli, in PMGC compared to HS.

  from the enrollement to the end of the investigation: 2 months

Study Arms (1)

neuroimaging assessment

EXPERIMENTAL

visual stimulation protocol during functional MRI session

Other: brain functional MRI

Interventions

brain functional MRI OTHER

visual protocol stimulation during brain functional MRI

neuroimaging assessment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. For PMGC: HD diagnosis confirmed by genetic testing (CAG triplets ≥36 in HTT gene); Unified Huntington Disease Rating Scale19 Total Motor Score (UHDRS-TMS) ≤ 5; age 18-70 years old. 2. For HC: normal neurological examination; age 18-70 years old.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble University Hospital

Grenoble, 38043, France

RECRUITING

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Sara Meoni, MD, PhD

CONTACT

+33 4 76 76 57 91; smeoni@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: February 20, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

FR (1)