- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01476228
EEG Objectification in Neuropsychiatry
November 17, 2011 updated by: Hadassah Medical Organization
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.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: shahar arzy, MD PhD
- Email: shahar.arzy@gmail.com
Study Locations
-
-
-
Jerusalem, Israel, 91120
- HMO
-
Contact:
- Shahar Arzy, MD PhD
- Phone Number: 97226777741
- Email: shahar.arzy@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 90 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosis of the investigated neuropsychiatric disease
Exclusion Criteria:
- Other co-existing neuropsychiatric conditions
- Refusal to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study group
EEG recording
|
EEG recording
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentage of fitting (0-100%) of EEG pattern to a previously identified electrophysiological "key"
Time Frame: 1 year
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: shahar arzy, MD PhD, HMO
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Anticipated)
November 1, 2013
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
August 22, 2011
First Submitted That Met QC Criteria
November 17, 2011
First Posted (Estimate)
November 22, 2011
Study Record Updates
Last Update Posted (Estimate)
November 22, 2011
Last Update Submitted That Met QC Criteria
November 17, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0394-11-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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