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Examination of Quantitative Electroencephalographic (QEEG) Biomarkers in Huntington's Disease (HD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00670709
Recruitment Status : Completed
First Posted : May 2, 2008
Results First Posted : August 16, 2010
Last Update Posted : February 11, 2013
Sponsor:
Collaborator:
High Q Foundation
Information provided by (Responsible Party):
Andrew F. Leuchter, University of California, Los Angeles

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Cross-Sectional
Condition Huntington's Disease
Enrollment 42
Recruitment Details Recruitment began September 2006 and ended in February 2008. All recruitment took place at UCLA Neurology Clinic and the UCLA Semel Institute.
Pre-assignment Details  
Arm/Group Title Huntington Disease Healthy Controls
Hide Arm/Group Description Subjects with mild or moderate Huntington's Disease Healthy control subjects
Period Title: Overall Study
Started 27 15
Completed 27 15
Not Completed 0 0
Arm/Group Title Huntington Disease Healthy Controls Total
Hide Arm/Group Description Subjects with mild or moderate Huntington's Disease Healthy control subjects Total of all reporting groups
Overall Number of Baseline Participants 27 15 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 15 participants 42 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
 100.0%
15
 100.0%
42
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 15 participants 42 participants
46.4  (11.3) 47.3  (9.7) 46.85  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 15 participants 42 participants
Female
11
  40.7%
8
  53.3%
19
  45.2%
Male
16
  59.3%
7
  46.7%
23
  54.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 15 participants 42 participants
27 15 42
1.Primary Outcome
Title Quantitative Electroencephalography Absolute Delta Power.
Hide Description Absolute power in the delta frequency as measured by quantitative electroencephalography
Time Frame baseline- one time point
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Huntington Disease Healthy Controls
Hide Arm/Group Description:
Subjects with mild or moderate Huntington's Disease
Healthy control subjects
Overall Number of Participants Analyzed 27 15
Mean (Standard Deviation)
Unit of Measure: microvolts squared
43.45  (10.83) 10.11  (3.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Huntington Disease, Healthy Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0000001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Quantitative Electroencephalography Absolute Alpha Power.
Hide Description Absolute power in the alpha frequency as measured by quantitative electroencephalography
Time Frame baseline EEG
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Huntington Disease Healthy Controls
Hide Arm/Group Description:
Subjects with mild or moderate Huntington's Disease
Healthy control subjects
Overall Number of Participants Analyzed 27 15
Mean (Standard Deviation)
Unit of Measure: microvolts squared
56.09  (62.61) 18.12  (15.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Huntington Disease, Healthy Controls
Comments HD subjects vs control subjects
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.005
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description There reason there was no serious adverse events and no other adverse events listed is because this was not a treatment study. It was an observed study, with no patients treated during the process. Therefore, there were no serious adverse events and no other adverse events recorded.
 
Arm/Group Title Huntington Disease Healthy Controls
Hide Arm/Group Description Subjects with mild or moderate Huntington's Disease Healthy control subjects
All-Cause Mortality
Huntington Disease Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Huntington Disease Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Huntington Disease Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jennifer Villalobos
Organization: UCLA
Phone: 310-825-3351
Responsible Party: Andrew F. Leuchter, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00670709     History of Changes
Other Study ID Numbers: QEEG and HD
First Submitted: April 30, 2008
First Posted: May 2, 2008
Results First Submitted: June 16, 2009
Results First Posted: August 16, 2010
Last Update Posted: February 11, 2013