NCT00670709

Brief Summary

The pace of basic science research defining the mechanisms of selective neuronal degeneration in Huntington disease (HD) has far exceeded the pace of translation of this information into clinically effective treatments for the disease. One reason for this bottleneck between bench and bedside is the paucity of available surrogate markers for HD. Identification of surrogate markers is critical for the design of future clinical trials. Such markers could provide a reliable signal of early brain dysfunction in HD and could be used as a biomarker in trials of agents that could prevent onset or delay progression of disease. Frontal-subcortical networks are known to be affected in HD and contribute to the cognitive dysfunction characteristic of the disease. Quantitative EEG (QEEG) can be used to assess the integrity of this circuitry; characteristic QEEG abnormalities long have been known to be present in the early stages of the illness (Bylsma et al., 1994). More recent research has suggested that a comprehensive topographic approach to QEEG analysis may reveal additional changes in brain activity (Bellotti et al., 2004) that may be indicative of subclinical disease (de Tommaso et al., 2003). This proposal aims to determine whether quantitative EEG techniques can be used to identify HD-specific abnormalities and thus serve as surrogate markers of disease. The goals of this pilot project are three-fold. First, we will determine if there are QEEG differences between normal control subjects and those with mild or moderate HD. Second, we will examine associations between severity of HD and the QEEG differences detected and determine if these QEEG differences are present when comparing the least affected HD subjects and normal controls. Third, we will examine associations between QEEG variables of interest and other clinical variables, including age of onset of symptoms, number of CAG repeats, severity of motor and behavioral symptoms as measured by the Unified Huntington Disease Rating Scale (UHDRS) subscores, and severity of cognitive impairment as measured by the cognitive subscore of the UHDRS and Mini-Mental State Examination (MMSE).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2008

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

August 16, 2010

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

April 30, 2008

Results QC Date

June 16, 2009

Last Update Submit

November 7, 2023

Conditions

Keywords

encephalographyquantitativebiomarkers

Outcome Measures

Primary Outcomes (2)

  • Quantitative Electroencephalography Absolute Delta Power.

    Absolute power in the delta frequency as measured by quantitative electroencephalography

    baseline- one time point

  • Quantitative Electroencephalography Absolute Alpha Power.

    Absolute power in the alpha frequency as measured by quantitative electroencephalography

    baseline EEG

Study Arms (2)

1

Subjects with mild or moderate Huntington's Disease

2

Normal Controls

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 subjects with mild or moderate Huntington's Disease and 15 healthy normal controls

You may qualify if:

  • Subjects affected by HD or those who are at risk for HD by virtue of having a first-degree relative with the illness, methamphetamine abuse or dependence, as well as normal controls, can participate.
  • All subjects will be above the age of 21.
  • Subjects will be recruited from clinical settings, and will also be self-referred.

You may not qualify if:

  • Individuals with pacemakers, infusion pumps, or metallic shrapnel will be excluded from MRI assessments.
  • Such implanted metals may be attracted by the MRI machine and put the individual at risk.
  • Moreover, individuals with a history of brain surgery and/or skull fracture will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Laboratory of Brain, Behavior,a nd PHarmacology

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Jennifer Villalobos
Organization
UCLA

Study Officials

  • Andrew F Leuchter, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Andrew F. Leuchter, M.D.

Study Record Dates

First Submitted

April 30, 2008

First Posted

May 2, 2008

Study Start

September 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

November 9, 2023

Results First Posted

August 16, 2010

Record last verified: 2023-11

Locations