The Effects of Repetitive Transcranial Magnetic Stimulation in Health Human Subjects - Full Text View

Purpose

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. Thirty-six healthy subjects will be randomized into three different treatment groups and receive 10 active or sham rTMS sessions 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 a marked potentiation of CI following 10 rTMS treatments compared to 1 rTMS treatment.
Hypothesis 4: 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.

Condition	Intervention
Repetitive Transcranial Magnetic Stimulation	Device: repetitive transcranial magnetic stimulation (rTMS) - 1Hz Device: repetitive transcranial magnetic stimulation (rTMS) - 20Hz Device: sham repetitive transcranial magnetic stimulation (rTMS)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Official Title:	The Effects of Repetitive Transcranial Magnetic Stimulation in Health Human Subjects

Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:

Changes in CI produced by different frequency of stimulus and duration of treatments indicated by LICI, CSP and SICI [ Time Frame: intermittent ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	April 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: repetitive transcranial magnetic stimulation (rTMS) - 1Hz 1 Hz
2: Experimental	Device: repetitive transcranial magnetic stimulation (rTMS) - 20Hz 20Hz
3: Sham Comparator	Device: sham repetitive transcranial magnetic stimulation (rTMS)

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658307

Contacts


Contact: Jeff Daskalakis, MD	416-535-8501 ext 4319	Jeff_Daskalakis@camh.net

Locations


Canada, Ontario
	Centre for Addiction and Mental Health	Recruiting
	Toronto, Ontario, Canada, M5T 1R8
	Contact: Jeff Daskalakis, MD 416-535-8501 ext 7376 Jeff_Daskalakis@camh.net
	Principal Investigator: Jeff Daskalakis, MD
	Sub-Investigator: Gabriela Favalli, MD
	Sub-Investigator: Shiu-Kai Liu, MD
	Sub-Investigator: Andrea Levinson, MD
	Sub-Investigator: Albert Wong, MD

Sponsors and Collaborators

Centre for Addiction and Mental Health

Investigators


Principal Investigator:	Jeff Daskalakis, MD	Centre for Addiction and Mental Health

More Information

Responsible Party:	Centre for Addiction and Mental Health ( Jeff Daskalakis )
Study ID Numbers:	009/2008
First Received:	April 11, 2008
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00658307
Health Authority:	Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:

repetitive transcranial magnetic stimulation

double-blind

sham-controlled

randomized

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Centre for Addiction and Mental Health
Information provided by:	Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:	NCT00658307