EEG Objectification in Neuropsychiatry

Depression Clinical Trial

Official title:

EEG Objectification in Neuropsychiatry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01476228
• Other study ID #: 0394-11-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: August 22, 2011
• Last updated: November 17, 2011
• Start date: November 2011
• Est. completion date: December 2015

Study information

• Verified date: August 2011
• Source: Hadassah Medical Organization
• Contact: shahar arzy, MD PhD
• Email: shahar.arzy[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 90 Years

Eligibility

Inclusion Criteria:

• diagnosis of the investigated neuropsychiatric disease

Exclusion Criteria:

• Other co-existing neuropsychiatric conditions

• Refusal to participate in the study

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Depression
• Epilepsy
• Nerve Degeneration
• Neurodegeneration
• Personality Disorder
• Personality Disorders

Intervention

Device:
• EEG recording
EEG recording

Locations

Country	Name	City	State
Israel	HMO	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Arzy S, Allali G, Brunet D, Michel CM, Kaplan PW, Seeck M. Antiepileptic drugs modify power of high EEG frequencies and their neural generators. Eur J Neurol. 2010 Oct;17(10):1308-12. doi: 10.1111/j.1468-1331.2010.03018.x. — View Citation

Arzy S, Collette S, Wissmeyer M, Lazeyras F, Kaplan PW, Blanke O. Psychogenic amnesia and self-identity: a multimodal functional investigation. Eur J Neurol. 2011 Dec;18(12):1422-5. doi: 10.1111/j.1468-1331.2011.03423.x. Epub 2011 May 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of fitting (0-100%) of EEG pattern to a previously identified electrophysiological "key"	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.	1 year	No