NCT00194870

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

7.2 years

First QC Date

September 12, 2005

Last Update Submit

August 17, 2018

Conditions

Epilepsy

Keywords

EEGDBS

Outcome Measures

Primary Outcomes (1)

  • NA- observational study

    5 years appr.

Study Arms (1)

Digital EEG

OTHER

Digital EEG

Procedure: EEG

Interventions

EEGPROCEDURE

computer-assisted analysis of the digitally-recorded EEG signals

Digital EEG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Weill Medical College at Cornell University - Comprehensive Epilepsy Center

New York, New York, 10021, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Douglas R Labar, MD, PhD

    Weill Medical College at Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

October 1, 2003

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 21, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)