HealthyNCT01041300
The Effects of Trancranial Magnetic Stimulation Multichannel Stimulator on Motor Excitation
A study testing Magstim Rapid2 Stimulator and Brainsway Multi-channel Stimulator in people with Healthy, run by Shalvata Mental Health Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Magstim Rapid2 Stimulator and Brainsway Multi-channel Stimulator
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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
- Being tested
- Magstim Rapid2 Stimulator, Brainsway Multi-channel Stimulator
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magstim Rapid2 StimulatorDevice
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 StimulatorDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between abductor policis brevis (APB) motor thresholds obtained with figure-8 using Magstim and Brainsway stimulators, for the same subjects
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brainsway
- Responsible party
- Sponsor
- Investigators
- Eiran V Harel, MD, Principal investigator, Shalvata Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041300
- Sponsor's protocol ID
- 0015-09-SHA
- Status last verified
- Jan 2012
- First submitted
- 22 Dec 2009
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Trancranial Magnetic Stimulation Multichannel Stimulator on Motor Excitation
- ClinicalTrials.gov ID
- NCT01041300
- Acronym / sponsor ID
- 0015-09-SHA
- Conditions
- Healthy
- Keywords
- Transcranial Magnetic Stimulation, TMS, Motor Threashold, Multiway, Magstim Rapid 2, Abductor policis brevis, Figure 8 coil, Double cone coil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Collaborators
- Brainsway
- Study start
- Jan 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 31 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magstim Rapid2 StimulatorDuration: 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 StimulatorFinding 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 | Device | – |
Primary outcome
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eiran V Harel, MD principal investigator
Shalvata Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magstim Rapid2 Stimulator and Brainsway Multi-channel Stimulator in people with Healthy, run by Shalvata Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2012.