The Effects of Trancranial Magnetic Stimulation Multichannel Stimulator on Motor Excitation

January 4, 2012 updated by: Shalvata Mental Health Center

Our aim is to Test the influence of a new multichanel Transcranial Magnetic Stimulation stimulator (Multiway) on motor excitation, in comparision to a wildly used Magstim Super Rapid 2 single channel stimulator.

Each of the 20 Healthy subjects that are inticipated to inrole to the study wiil undergo 6 simple procedures which are designed to compare the motor threshold obtained by diffrent combination of TMs coils (figure 8, double cone coil,H coil array) and stimulators (Multiway, Super Rapid 2).

The entire length of the procedures is about 4 hours and all subjects will be paid for their participation in the study.

Our main hypothesis is that the motor threshold obtained by the multichanel stimulator will be significtly lower then the single chanel stimulator.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

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

  • Israel
      • Hod-Hasharon, Israel
        • Shalvata Mental Health Center

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Individuals between the ages of 18-65
  2. Right handed individuals
  3. Individual provides Negative responses to the questions on the safety questionnaire completed prior to TMS treatment.
  4. Individual gave both written and verbal consent to participation in the study.

Exclusion Criteria:

  1. Individual suffers from an Axis I disorder, as diagnosed in a Clinical interview with a Psychiatrist.
  2. Individual suffers from an Axis II disorder, as diagnosed in a Clinical interview with a Psychiatrist.
  3. Individual has a history of high blood pressure.
  4. Individual has a history of epilepsy, epileptic seizure, or febrile seizures.
  5. Individual has family members with a history of epilepsy, epileptic seizures or febrile seizures.
  6. Individual has a history of head injury.
  7. Individual has any metal implants in head (except for dental implants)
  8. Individual has history of surgery, including metal implants or individual has a known history of metal particals in the eye, heart pumps, neurostimulator use, or any other medical pump.
  9. Individual has a history of migrane.
  10. Individual has a history of hearing problems or deafness.
  11. Individual has a hisotry of hearing aids or implants.
  12. Individual has a hisotry of drug or alcohol addiction.
  13. Individual is pregnant or is sexually active and not using contraception.
  14. Individual is to difficult to contact.
  15. Indicidual has a legal gaurdian.
  16. Individual is currently enroleld in another medical study.
  17. Individual is a soldier, a prisoner or a convict.

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison between abductor policis brevis (APB) motor thresholds obtained with figure-8 using Magstim and Brainsway stimulators, for the same subjects
Time Frame: one day
one day
Comparison between the total power required for APB motor thresholds obtained with figure-8 Coil operated with a single channel, and circular coils operated with several channels of the Brainsway stimulator, for the same subjects.
Time Frame: one day
one day
Comparison between the total power required for leg motor thresholds obtained with Double Cone Coil operated with a single channel, and circular coils operated with several channels of the Brainsway stimulator, for the same subjects.
Time Frame: one day
one day
Comparison between the latency times for leg motor thresholds obtained with Double Cone Coil operated with a single channel, and circular coils operated with several channels of the Brainsway stimulator, for the same subjects.
Time Frame: one day
one day
Comparison between the motor thresholds and motor evoked potentials (MEPs) obtained with various combinations of relative intensities of pulses produced by several channels of the multi-channel Brainsway stimulator.
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shalvata Mental Health Center

Collaborators

Brainsway

Investigators

  • Principal Investigator: Eiran V Harel, MD, Shalvata Mental Health Center

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

January 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

December 30, 2009

First Posted (Estimate)

December 31, 2009

Study Record Updates

Last Update Posted (Estimate)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 4, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0015-09-SHA

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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