Examination of Quantitative Electroencephalographic (QEEG) Biomarkers in Huntington's Disease
HD
1 other identifier
observational
42
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 30, 2008
CompletedFirst Posted
Study publicly available on registry
May 2, 2008
CompletedResults Posted
Study results publicly available
August 16, 2010
CompletedNovember 9, 2023
November 1, 2023
1.4 years
April 30, 2008
June 16, 2009
November 7, 2023
Conditions
Keywords
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
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
- University of California, Los Angeleslead
- High Q Foundationcollaborator
Study Sites (1)
UCLA Laboratory of Brain, Behavior,a nd PHarmacology
Los Angeles, California, 90024, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Villalobos
- Organization
- UCLA
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew F Leuchter, MD
University of California, Los Angeles
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