HealthyNCT00658307
The Effects of Repetitive Transcranial Magnetic Stimulation in Healthy Human Subjects
A study testing repetitive transcranial magnetic stimulation (rTMS) in people with Healthy, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
It has been suggested that the therapeutic effects of repetitive transcranial magnetic stimulation (rTMS) are mediated through changes in cortical inhibition (CI). However, in healthy subjects the effects of rTMS on CI have been inconsistent. 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?
- repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to May 2014
- 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
- are voluntary and competent to consent
- between the ages of 18-65
- considered a healthy individual free of psychopathology based on the Personality Assessment Inventory
- right-handed determined by the TMS-screener and demographic form
- self-reported non-smoker
- do not have a self-reported concomitant major medical or neurologic illness
- women in childbearing years will be recruited only if they are on an effective means of birth control determined through completion of the TMS screener and demographic form.
Who cannot join
- demonstrate a failure to tolerate the procedure
- develop any significant adverse events (e.g., seizure or seizure-like activity)
- withdraw consent
- the principal investigator believes that for safety reasons it is in the best interest of the individual to be withdrawn
Trial locations and contacts
1 site in 1 country.
About this study
It has been suggested that the therapeutic effects of repetitive transcranial magnetic stimulation (rTMS) are mediated through changes in cortical inhibition (CI). However, in healthy subjects the effects of rTMS on CI have been inconsistent. The aim of this study is to explore different rTMS - stimulus conditions neurophysiological and molecular mechanisms in the human motor cortex. Fifty-six healthy subjects will be randomized into three different treatment groups and receive 1 active or sham rTMS session (6000 rTMS pulses) at 90% of their motor threshold (MT). Cortical inhibition will be indexed pre and post treatment using short-interval intracortical inhibition (SICI), cortical silent period (CSP) and long-interval cortical inhibition (LICI).
Based on previous studies we hypothesize that:
- Hypothesis 1: rTMS will result in a greater CI (i.e., prolonged CSP, increased LICI but not SICI) compared to sham rTMS.
- Hypothesis 2: 20 Hz rTMS will result in a significantly greater CI compared to 1 Hz rTMS.
- Hypothesis 3: There will be distinctive transcription profiles associated with increases in CI from rTMS that can be detected with whole-genome microarray analysis of peripheral leukocytes.
Read the detailed description
It has been demonstrated that several neurologic and psychiatry disorders are associated with dysfunctional cortical inhibitory mechanisms and alterations in neurotrophins (biological markers involved in neuronal survival and plasticity) and that rTMS therapeutic effects are associated with changes in cortical excitability. CI produced by rTMS can be demonstrated through SICI, CSP and LICI. However it remains unclear which rTMS parameters induce the best CI. Exploring different rTMS stimulus conditions versus sham condition effects in CI of human motor cortex can be the way to identify the best rTMS therapeutic parameters. Also, evaluating the molecular effects produced by rTMS treatment on serum blood levels can help identify the mechanisms through which rTMS exerts its therapeutic effects and ultimately clarify mechanisms through which treatment effects are mediated.
This experiment intends to demonstrate the best rTMS parameters to acquire higher CI. If our hypotheses are correct, these parameters will help to obtain higher therapeutic effects, and consequently, improvement of rTMS treatments.
- Conditions
- Healthy
- Being tested
- repetitive transcranial magnetic stimulation (rTMS), sham repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- repetitive transcranial magnetic stimulation, double-blind, sham-controlled, randomized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation (rTMS)Device
Also called MagPro X100 Series
1 Hz
The rTMS device is the "MagPro X100 Series" (produced by Magventure A/S, Farum, Denmark)
repetitive transcranial magnetic stimulation (rTMS)Device
Also called MagPro X100 Series
20Hz
The rTMS device is the "MagPro X100 Series" (produced by Magventure A/S, Farum, Denmark)
sham repetitive transcranial magnetic stimulation (rTMS)Device
Also called MagPro X100 Series
The rTMS device is the "MagPro X100 Series" (produced by Magventure A/S, Farum, Denmark)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: repetitive transcranial magnetic stimulation (rTMS) |
| 2 | Experimental | Not described Receives: Device: repetitive transcranial magnetic stimulation (rTMS) |
| 3 | Sham comparator | Not described Receives: Device: sham repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in CI produced by different frequency of stimulus and duration of treatments indicated by LICI, CSP and SICI
Measured: intermittent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2014
- Study completionMay 2014
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.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Z. J. Daskalakis, Centre for Addiction and Mental Health
- Investigators
- Jeff Daskalakis, MD, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658307
- Sponsor's protocol ID
- 009/2008
- Status last verified
- May 2014
- First submitted
- 11 Apr 2008
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Repetitive Transcranial Magnetic Stimulation in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT00658307
- Acronym / sponsor ID
- 009/2008
- Conditions
- Healthy
- Keywords
- repetitive transcranial magnetic stimulation, double-blind, sham-controlled, randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Apr 2008 (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.
It has been suggested that the therapeutic effects of repetitive transcranial magnetic stimulation (rTMS) are mediated through changes in cortical inhibition (CI). However, in healthy subjects the effects of rTMS on CI have been inconsistent. The aim of this study is to explore different rTMS - stimulus conditions neurophysiological and molecular mechanisms in the human motor cortex. Fifty-six healthy subjects will be randomized into three different treatment groups and receive 1 active or sham rTMS session (6000 rTMS pulses) at 90% of their motor threshold (MT). Cortical inhibition will be indexed pre and post treatment using short-interval intracortical inhibition (SICI), cortical silent period (CSP) and long-interval cortical inhibition (LICI).
Based on previous studies we hypothesize that:
- Hypothesis 1: rTMS will result in a greater CI (i.e., prolonged CSP, increased LICI but not SICI) compared to sham rTMS.
- Hypothesis 2: 20 Hz rTMS will result in a significantly greater CI compared to 1 Hz rTMS.
- Hypothesis 3: There will be distinctive transcription profiles associated with increases in CI from rTMS that can be detected with whole-genome microarray analysis of peripheral leukocytes.
Detailed description
It has been demonstrated that several neurologic and psychiatry disorders are associated with dysfunctional cortical inhibitory mechanisms and alterations in neurotrophins (biological markers involved in neuronal survival and plasticity) and that rTMS therapeutic effects are associated with changes in cortical excitability. CI produced by rTMS can be demonstrated through SICI, CSP and LICI. However it remains unclear which rTMS parameters induce the best CI. Exploring different rTMS stimulus conditions versus sham condition effects in CI of human motor cortex can be the way to identify the best rTMS therapeutic parameters. Also, evaluating the molecular effects produced by rTMS treatment on serum blood levels can help identify the mechanisms through which rTMS exerts its therapeutic effects and ultimately clarify mechanisms through which treatment effects are mediated.
This experiment intends to demonstrate the best rTMS parameters to acquire higher CI. If our hypotheses are correct, these parameters will help to obtain higher therapeutic effects, and consequently, improvement of rTMS treatments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS) |
| 2 | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS) |
| 3 | Sham comparator | Device: sham repetitive transcranial magnetic stimulation (rTMS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- are voluntary and competent to consent
- between the ages of 18-65
- considered a healthy individual free of psychopathology based on the Personality Assessment Inventory
- right-handed determined by the TMS-screener and demographic form
- self-reported non-smoker
Key exclusion criteria (4 listed)
- demonstrate a failure to tolerate the procedure
- develop any significant adverse events (e.g., seizure or seizure-like activity)
- withdraw consent
- the principal investigator believes that for safety reasons it is in the best interest of the individual to be withdrawn
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 |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS)Also: MagPro X100 Series1 Hz The rTMS device is the "MagPro X100 Series" (produced by Magventure A/S, Farum, Denmark) | Device | 1 |
| repetitive transcranial magnetic stimulation (rTMS)Also: MagPro X100 Series20Hz The rTMS device is the "MagPro X100 Series" (produced by Magventure A/S, Farum, Denmark) | Device | 2 |
| sham repetitive transcranial magnetic stimulation (rTMS)Also: MagPro X100 SeriesThe rTMS device is the "MagPro X100 Series" (produced by Magventure A/S, Farum, Denmark) | Device | 3 |
Primary outcome
Changes in CI produced by different frequency of stimulus and duration of treatments indicated by LICI, CSP and SICI
Time frame: intermittent
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 2 May 2014.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
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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.
Jeff Daskalakis, MD, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation (rTMS) in people with Healthy, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 7 inclusion and 4 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 2 May 2014. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Changes in CI produced by different frequency of stimulus and duration of treatments indicated by LICI, CSP and SICI (time frame: intermittent). 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 2 May 2014.