Magnetic Prefrontal Stimulation for Studying the Role of... | NCT00912522

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

NCT00912522

Sponsor

Hadassah Medical Organization

Status

Completed

Last Update Posted

Apr 22, 2015Estimated

Enrollment

91Actual

Phase

Early Phase 1

Conditions

Healthy Volunteers

Interventions

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jun 2, 2009

First Submission Date that Met QC Criteria

Jun 2, 2009

First Posted Date

Jun 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2015

Last Update Posted Date

Apr 22, 2015Estimated

Name	Class
Ben-Gurion University of the Negev	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

91Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
LT PFC HIGH FREQ TMS	Active Comparator	Device: TMS
LT PFC LOW FREQ TMS	Active Comparator	Device: TMS
RT PFC HIGH FREQ TMS	Active Comparator	Device: TMS
RT PFC LOW FREQ TMS	Active Comparator	Device: TMS
SHAM STIMULATION	Sham Comparator	Device: TMS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TMS	Device	TRANSCRANIAL MAGNETIC STIMULATION	LT PFC HIGH FREQ TMS LT PFC LOW FREQ TMS RT PFC HIGH FREQ TMS RT PFC LOW FREQ TMS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in scoring of different tests and questionnaires		One year

Secondary Outcomes

Measure	Description	Time Frame
Correlation of different tests and questionnaires		One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Moshe Isserles, Dr.	Hadassa Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah medical org		Jerusalem			Israel