Magnetic Prefrontal Stimulation for Studying the Role of the Cortex in High-level Cognition Processes and Reward System

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Completed
• CT.gov ID: NCT00912522
• Collaborator: Ben-Gurion University of the Negev (Other)
• Enrollment: 91
• Location: 1
• Arms: 5
• Duration (Months): 60
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Device: TMS	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Magnetic Prefrontal Stimulation for Studying the Role of the Cortex in High-level Cognition Processes and Reward System
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LT PFC HIGH FREQ TMS	Device: TMS; TRANSCRANIAL MAGNETIC STIMULATION
Active Comparator: LT PFC LOW FREQ TMS	Device: TMS; TRANSCRANIAL MAGNETIC STIMULATION
Active Comparator: RT PFC HIGH FREQ TMS	Device: TMS; TRANSCRANIAL MAGNETIC STIMULATION
Active Comparator: RT PFC LOW FREQ TMS	Device: TMS; TRANSCRANIAL MAGNETIC STIMULATION
Sham Comparator: SHAM STIMULATION	Device: TMS; TRANSCRANIAL MAGNETIC STIMULATION

Outcome Measures

Primary Outcome Measures

1. Changes in scoring of different tests and questionnaires [One year]

Secondary Outcome Measures

1. Correlation of different tests and questionnaires [One year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah medical org	Jerusalem		Israel

Sponsors and Collaborators

• Hadassah Medical Organization
• Ben-Gurion University of the Negev

Investigators

• Principal Investigator: Moshe Isserles, Dr., Hadassa Medical Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Moshe Isserles, MD, Hadassah Medical Organization
• ClinicalTrials.gov Identifier: NCT00912522
• Other Study ID Numbers: 0116-09-HMO-CTIL
• First Posted: Jun 3, 2009
• Last Update Posted: Apr 22, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Moshe Isserles, MD, Hadassah Medical Organization: reward; TMS; cognition; Motivation; Perception; Decision making

Study Results

No Results Posted as of Apr 22, 2015