The Effects of Repetitive Transcranial Magnetic Stimulation in Healthy Human Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Z. J. Daskalakis, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00658307
First received: April 11, 2008
Last updated: May 1, 2014
Last verified: May 2014
  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. 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.

Condition Intervention
Healthy
Device: repetitive transcranial magnetic stimulation (rTMS)
Device: sham repetitive transcranial magnetic stimulation (rTMS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Repetitive Transcranial Magnetic Stimulation in Healthy 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 ]

Enrollment: 56
Study Start Date: April 2008
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: repetitive transcranial magnetic stimulation (rTMS)

1 Hz

The rTMS device is the "MagPro X100 Series" (produced by Magventure A/S, Farum, Denmark)

Other Name: MagPro X100 Series
Experimental: 2 Device: repetitive transcranial magnetic stimulation (rTMS)

20Hz

The rTMS device is the "MagPro X100 Series" (produced by Magventure A/S, Farum, Denmark)

Other Name: MagPro X100 Series
Sham Comparator: 3 Device: sham repetitive transcranial magnetic stimulation (rTMS)
The rTMS device is the "MagPro X100 Series" (produced by Magventure A/S, Farum, Denmark)
Other Name: MagPro X100 Series

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H4
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Jeff Daskalakis, MD, PhD Centre for Addiction and Mental Health
  More Information

Additional Information:
No publications provided

Responsible Party: Z. J. Daskalakis, Chair, Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00658307     History of Changes
Other Study ID Numbers: 009/2008
Study First Received: April 11, 2008
Last Updated: May 1, 2014
Health Authority: Canada: Ethics Review Committee

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 20, 2014