Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Electroencephalography (EEG) and Deep Brain Stimulation (DBS) in Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Douglas R. Labar, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00194870
First received: September 12, 2005
Last updated: January 11, 2017
Last verified: January 2017
  Purpose
Patients with epilepsy undergoing deep brain stimulation (DBS) have electroencephalograms (EEGs) recorded before and during their stimulation treatment. Subsequently the investigators will be using computer-assisted analysis of the digitally-recorded EEG signals to assess the effects of DBS on the brain-wave frequency content and any abnormal seizure-like patterns that may be present.

Condition Intervention
Epilepsy
Procedure: computer-assisted analysis of the digitally-recorded EEG signals

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Electroencephalography (EEG) and Deep Brain Stimulation (DBS) in Epilepsy

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • NA- observational study [ Time Frame: 5 years appr. ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: October 2003
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Digital EEG
Digital EEG
Procedure: computer-assisted analysis of the digitally-recorded EEG signals
computer-assisted analysis of the digitally-recorded EEG signals

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To be scheduled to undergo deep brain stimulation therapy (DBS) in an attempt to treat intractable epilepsy

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194870

Locations
United States, New York
Weill Medical College at Cornell University - Comprehensive Epilepsy Center
New York, New York, United States, 10021
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Douglas R. Labar
Investigators
Principal Investigator: Douglas R Labar, MD, PhD Weill Medical College at Cornell University
  More Information

Responsible Party: Douglas R. Labar, Director of Clinical neurophysiology, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00194870     History of Changes
Other Study ID Numbers: 0309006367 
Study First Received: September 12, 2005
Last Updated: January 11, 2017
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Weill Medical College of Cornell University:
EEG
DBS

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2017