Clinical trial NCT01041300: The Effects of Trancranial Magnetic Stimulation Multichannel Stimulator on Motor Excitation
Official title: The Effects of Trancranial Magnetic Stimulation Multichannel Stimulator on Motor Excitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Transcranial Magnetic Stimulation
TMS
Motor Threashold
Multiway
Magstim Rapid 2
Abductor policis brevis
Figure 8 coil
Double cone coil
Circular coil
Brainsway
Healthy participants.
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
Collaborators: name: Brainsway
First posted: 2009-12-31
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Comparison between abductor policis brevis (APB) motor thresholds obtained with figure-8 using Magstim and Brainsway stimulators, for the same subjects
timeFrame: one day
measure: 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.
timeFrame: one day
measure: 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.
timeFrame: one day
measure: 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.
timeFrame: one day
measure: 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.
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Hod-Hasharon
country: Israel
facility: Shalvata Mental Health Center
Study officials:
affiliation: Shalvata Mental Health Center
name: Eiran V Harel, MD
role: PRINCIPAL_INVESTIGATOR
References: