NCT00912522

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P75+ for early_phase_1 healthy-volunteers

Timeline
Completed

Started Jun 2009

Longer than P75 for early_phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

5 years

First QC Date

June 2, 2009

Last Update Submit

April 20, 2015

Conditions

Healthy Volunteers

Keywords

rewardTMScognitionMotivationPerceptionDecision making

Outcome Measures

Primary Outcomes (1)

  • Changes in scoring of different tests and questionnaires

    One year

Secondary Outcomes (1)

  • Correlation of different tests and questionnaires

    One year

Study Arms (5)

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

TMSDEVICE

TRANSCRANIAL MAGNETIC STIMULATION

LT PFC HIGH FREQ TMSLT PFC LOW FREQ TMSRT PFC HIGH FREQ TMSRT PFC LOW FREQ TMSSHAM STIMULATION

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • self history of significant mental disorder
  • self history or first-degree relatives history of epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah medical org

Jerusalem, Israel

Location

Study Officials

  • Moshe Isserles, Dr.

    Hadassa Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 3, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

IL(1)