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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01476228
Other study ID # 0394-11-HMO-CTIL
Secondary ID
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


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
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