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Completed

NCT Number: NCT01041300

The Effects of Trancranial Magnetic Stimulation Multichannel Stimulator on Motor Excitation

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shalvata Mental Health Center

Hod HaSharon, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Individual suffers from an Axis I disorder, as diagnosed in a Clinical interview with a Psychiatrist.
  • Individual suffers from an Axis II disorder, as diagnosed in a Clinical interview with a Psychiatrist.
  • Individual has a history of high blood pressure.
  • Individual has a history of epilepsy, epileptic seizure, or febrile seizures.
  • Individual has family members with a history of epilepsy, epileptic seizures or febrile seizures.
  • Individual has a history of head injury.
  • Individual has any metal implants in head (except for dental implants)
  • 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.
  • Individual has a history of migrane.
  • Individual has a history of hearing problems or deafness.
  • Individual has a hisotry of hearing aids or implants.
  • Individual has a hisotry of drug or alcohol addiction.
  • Individual is pregnant or is sexually active and not using contraception.
  • Individual is to difficult to contact.
  • Indicidual has a legal gaurdian.
  • Individual is currently enroleld in another medical study.
  • Individual is a soldier, a prisoner or a convict.

Treatment and study plan

Magstim Rapid2 Stimulator

Device

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

Brainsway Multi-channel Stimulator

Device

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Shalvata Mental Health Center

Other

Collaborators

  • Brainsway

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 31, 2009
Registry last updated
Jan 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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