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EEG Objectification in Neuropsychiatry

Primary Purpose

Personality Disorder, Depression, Neurodegeneration

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
EEG recording
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Personality Disorder

Eligibility Criteria

15 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • diagnosis of the investigated neuropsychiatric disease

Exclusion Criteria:

  • Other co-existing neuropsychiatric conditions
  • Refusal to participate in the study

Sites / Locations

  • HMO

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study group

Arm Description

EEG recording

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 22, 2011
Last Updated
November 17, 2011
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01476228
Brief Title
EEG Objectification in Neuropsychiatry
Official Title
EEG Objectification in Neuropsychiatry
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Personality Disorder, Depression, Neurodegeneration, Alzheimer's Disease, Epilepsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
EEG recording
Intervention Type
Device
Intervention Name(s)
EEG recording
Intervention Description
EEG recording
Primary Outcome Measure Information:
Title
percentage of fitting (0-100%) of EEG pattern to a previously identified electrophysiological "key"
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diagnosis of the investigated neuropsychiatric disease Exclusion Criteria: Other co-existing neuropsychiatric conditions Refusal to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shahar arzy, MD PhD
Email
shahar.arzy@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shahar arzy, MD PhD
Organizational Affiliation
HMO
Official's Role
Principal Investigator
Facility Information:
Facility Name
HMO
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahar Arzy, MD PhD
Phone
97226777741
Email
shahar.arzy@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
21554495
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.
Results Reference
result
PubMed Identifier
20402743
Citation
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.
Results Reference
result

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EEG Objectification in Neuropsychiatry

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