The Effects of Trancranial Magnetic Stimulation Multichannel Stimulator on Motor Excitation

NCT ID: NCT01041300

Last Updated: 2012-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-10-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brainsway

INDUSTRY

Sponsor Role: collaborator

Shalvata Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eiran V Harel, MD

Role: PRINCIPAL_INVESTIGATOR

Shalvata Mental Health Center

Locations

Shalvata Mental Health Center

Hod HaSharon, , Israel

Countries

Israel

Other Identifiers

0015-09-SHA

Identifier Type: -

Identifier Source: org_study_id