Text Size

EEG Objectification in Neuropsychiatry

This study is not yet open for participant recruitment.
Verified August 2011 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01476228
First received: August 22, 2011
Last updated: November 17, 2011
Last verified: August 2011
History of Changes
  Purpose

The main objective of the study is to evaluate the use of EEG in the management and follow-up of neuropsychiatric disorders. Secondary objectives are therefore better understanding of the pathological activations in neural network during neuropsychiatric disorders, their clinical evolution and response to therapies.


Condition Intervention
Personality Disorder
Depression
Neurodegeneration
Alzheimer's Disease
Epilepsy
 Device: EEG recording

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: EEG Objectification in Neuropsychiatry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • percentage of fitting (0-100%) of EEG pattern to a previously identified electrophysiological "key" [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The study will decode an EEG-based "key" (or electrophysiological pattern) for specific effect (such as the use of anti-epileptic agent or a certain condition) by comparing EEG before and after the use of this agent. For each patient the statistical fitting of the recorded EEG to the key will be evaluated by percentage (0-100%), describing fitting of the individual patient's EEG to the identified key.


Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: study group
EEG recording
 Device: EEG recording
EEG recording

Detailed Description:

Patients are having EEG recordings as a routine part of their clinical evaluation and diagnosis. EEG recording is harmless, has no side effects, any radiation or any mechanical or electrical influence. It is of short duration and may be done in the EEG institute or the patient's room.

  Eligibility

Ages Eligible for Study:   15 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diagnosis of the investigated neuropsychiatric disease

Exclusion Criteria:

  • Other co-existing neuropsychiatric conditions
  • Refusal to participate in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476228

Contacts
Contact: shahar arzy, MD PhD shahar.arzy@gmail.com

Locations
Israel
HMO Not yet recruiting
Jerusalem, Israel, 91120
Contact: Shahar Arzy, MD PhD     97226777741     shahar.arzy@gmail.com    
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: shahar arzy, MD PhD HMO
  More Information

Publications:

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01476228     History of Changes
Other Study ID Numbers: 0394-11-HMO-CTIL
Study First Received: August 22, 2011
Last Updated: November 17, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Alzheimer Disease
Depression
Depressive Disorder
Epilepsy
Nerve Degeneration
Personality Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013