The Effects of Trancranial Magnetic Stimulation Multichannel Stimulator on Motor Excitation

This study has been completed.
Sponsor:
Collaborator:
Brainsway
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01041300
First received: December 22, 2009
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Healthy
Device: Magstim Rapid2 Stimulator
Device: Brainsway Multi-channel Stimulator

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Effects of Trancranial Magnetic Stimulation Multichannel Stimulator on Motor Excitation

Resource links provided by NLM:


Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: January 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Magstim Rapid2 Stimulator

    Duration: Time is takes to find motor thresholds obtained with figure-8 coil using Magstim Rapid2 Stimulator (Estimated at 15 minutes).

    Total Duration of device: 15 minutes

    Device: Brainsway Multi-channel Stimulator

    Finding motor thresholds using the figure-8 coil and the Brainsway Multi-channel Stimulator (Estimated at 15 minutes).

    Finding motor threshold of leg obtained with Double Cone coil using the Brainsway Multi-channel Stimulator (Estimated at 15 minutes).

    Finding motor threshold of leg obtained with circular coils using the Brainsway Multi-channel Stimulator (Estimated at 15 minutes).

    Finding motor threshold of thumb obtained with circular coils on multiple channels using the Brainsway Multi-channel Stimulator (Estimated at 15 minutes).

    Finding motor thresholds of multiple channels using the Brainsway Multi-channel Stimulator (Estimated at 1 hour).

    Finding specificity of the motor thresholds of multiple channels using the Brainsway Multi-channel Stimulator (Estimated at 30 minutes).

    Total Duration with Device: 2 hours and 30 minutes

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041300

Locations
Israel
Shalvata Mental Health Center
Hod-Hasharon, Israel
Sponsors and Collaborators
Shalvata Mental Health Center
Brainsway
Investigators
Principal Investigator: Eiran V Harel, MD Shalvata Mental Health Center
  More Information

No publications provided

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01041300     History of Changes
Other Study ID Numbers: 0015-09-SHA
Study First Received: December 22, 2009
Last Updated: January 4, 2012
Health Authority: Israel: minitery of health

Keywords provided by Shalvata Mental Health Center:
Transcranial Magnetic Stimulation
TMS
Motor Threashold
Multiway
Magstim Rapid 2
Abductor policis brevis
Figure 8 coil
Double cone coil
Circular coil
Brainsway
Healthy participants.

ClinicalTrials.gov processed this record on April 23, 2014