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Child to Adult Neurodevelopment in Gene Expanded Huntington's Disease

NCT ID: NCT01860339

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2026-08-31

Brief Summary

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Huntington's Disease (HD) is an autosomal dominant disease manifested in a triad of cognitive, psychiatric, and motor signs and symptoms. HD is caused by a triplet repeat (CAG)expansion in the gene Huntingtin (HTT). This disease has classically been conceptualized as a neurodegenerative disease. However, recent evidence suggests that abnormal brain development may play an important role in the etiology of HD. Huntingtin (HTT)is expressed during development and through life. In animal studies, the HTT gene has been shown to be vital for brain development. This suggests that a mutant form of HTT (gene-expanded or CAG repeats of 40 and above) would affect normal brain development. In addition, studies in adults who are gene-expanded for HD, but have not yet manifested the illness, (pre-HD subjects) have significant changes in the structure of their brain, even up to 20 years before onset of clinical diagnosis. How far back these changes are evident is unknown. One possibility is that these brain changes are present throughout life, due to changes in brain development,though initially associated with only subtle functional abnormalities.

In an effort to better understand the developmental aspects of this brain disease, the current study proposes to evaluate brain structure and function in children, adolescents, and young adults (ages 6-30) who are at risk for developing HD - those who have a parent or grandparent with HD. Brain structure will be evaluating using Magnetic Resonance Imaging (MRI) with quantitative measures of the entire brain, cerebral cortex, as well as white matter integrity via Diffusion Tensor Imaging. Brain function will be assessed by cognitive tests, behavioral assessment, and physical and neurologic evaluation. Subjects that are gene-expanded (GE) will be compared to subjects who are gene non-expanded (GNE). Changes in brain structure and/or function in the GE group compared to the GNE group would lend support to the notion that this disease has an important developmental component.

Detailed Description

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Conditions

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Huntington's Disease

Keywords

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Huntington's Disease HD Huntington Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Gene-expanded (GE)

Children at risk for HD who have a CAG repeat length of 40 and above.

No interventions assigned to this group

Gene Non-Expanded (GNE)

Children at risk for HD who have a CAG repeat length of 39 or less

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Family history of Huntington's Disease
* Age 6-30 years
* Age-appropriate knowledge of HD and personal risk

Exclusion Criteria

* Metal in body, including braces
* History of head trauma, brain tumor, seizures, epilepsy
* History of major surgery and/or significant ongoing medical issue(s)
Minimum Eligible Age

6 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Peggy C Nopoulos

OTHER

Sponsor Role lead

Responsible Party

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Peggy C Nopoulos

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Peggy C Nopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of California Davis

Sacramento, California, United States

Site Status RECRUITING

University of Iowa Hospitals and Clinics, Department of Psychiatry

Iowa City, Iowa, United States

Site Status RECRUITING

Columbia University Medical Center

New York, New York, United States

Site Status RECRUITING

Children's Hospital of Philadelphia with the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Staff

Role: CONTACT

Phone: 866-514-0858

Email: [email protected]

Sonia K Slevinski, MS

Role: CONTACT

Phone: 319-353-8529

Email: [email protected]

Facility Contacts

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Fernando Rodriguez

Role: primary

Lauri Jennisch, MS

Role: primary

Keara Turkington, BA

Role: backup

Mia Parker, BA

Role: primary

Shana Ward, BS

Role: primary

Isabelle Taylor, BS

Role: primary

Kelly Watson, PhD

Role: backup

Brittany Duncan, BS

Role: primary

Related Links

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http://www.kids-hd.org

Previous study site

https://www.facebook.com/ChangeHDresearch/

Facebook page

https://twitter.com/ChANGEHD_study

Twitter account

Other Identifiers

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2U01NS055903-10

Identifier Type: NIH

Identifier Source: secondary_id

View Link

200507759

Identifier Type: -

Identifier Source: org_study_id