- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00912522
Magnetic Prefrontal Stimulation for Studying the Role of the Cortex in High-level Cognition Processes and Reward System
April 20, 2015 updated by: Moshe Isserles, Hadassah Medical Organization
The investigators intend to study the role of the cortex in high- level cognition processes and sensory adaptation, by the use of non-invasive Transcranial Magnetic stimulation and various cognitive tests.
Study Overview
Study Type
Interventional
Enrollment (Actual)
91
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Jerusalem, Israel
- Hadassah medical org
-
-
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
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy men and women, age of 18-60
- answered negatively to questions of TMS safety questionnaire
- signed and declared about their agreement to participate in the study
- hebrew speaker
Exclusion Criteria:
- self history of significant mental disorder
- self history or first-degree relatives history of epilepsy
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: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: LT PFC HIGH FREQ TMS
|
TRANSCRANIAL MAGNETIC STIMULATION
|
Active Comparator: LT PFC LOW FREQ TMS
|
TRANSCRANIAL MAGNETIC STIMULATION
|
Active Comparator: RT PFC HIGH FREQ TMS
|
TRANSCRANIAL MAGNETIC STIMULATION
|
Active Comparator: RT PFC LOW FREQ TMS
|
TRANSCRANIAL MAGNETIC STIMULATION
|
Sham Comparator: SHAM STIMULATION
|
TRANSCRANIAL MAGNETIC STIMULATION
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in scoring of different tests and questionnaires
Time Frame: One year
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation of different tests and questionnaires
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Moshe Isserles, Dr., Hadassa Medical Organization
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
June 1, 2009
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
June 2, 2009
First Submitted That Met QC Criteria
June 2, 2009
First Posted (Estimate)
June 3, 2009
Study Record Updates
Last Update Posted (Estimate)
April 22, 2015
Last Update Submitted That Met QC Criteria
April 20, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0116-09-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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