The Effects of Repetitive Transcranial Magnetic Stimulation in Healthy Human Subjects

NCT ID: NCT00658307

Last Updated: 2014-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2014-05-31

Brief 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. 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: DEVICE

1 Hz

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

2

Group Type: EXPERIMENTAL

repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: DEVICE

20Hz

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

3

Group Type: SHAM_COMPARATOR

sham repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: DEVICE

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

Interventions

repetitive transcranial magnetic stimulation (rTMS)

1 Hz

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

Intervention Type: DEVICE

repetitive transcranial magnetic stimulation (rTMS)

20Hz

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

Intervention Type: DEVICE

sham repetitive transcranial magnetic stimulation (rTMS)

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

Intervention Type: DEVICE

Other Intervention Names

MagPro X100 Series; MagPro X100 Series; MagPro X100 Series

Eligibility 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

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

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Z. J. Daskalakis

Chair, Temerty Centre for Therapeutic Brain Intervention

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeff Daskalakis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Countries

Canada

Related Links

http://www.camh.net/research

Information about research at the Centre for Addiction and Mental Health

Other Identifiers

009/2008

Identifier Type: -

Identifier Source: org_study_id