The Effects of Repetitive Transcranial Magnetic Stimulation in Healthy Human Subjects

May 1, 2014 updated by: Z. J. Daskalakis, Centre for Addiction and Mental Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J 1H4
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • MagPro X100 Series
Device: repetitive transcranial magnetic stimulation (rTMS)

20Hz

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

Other Names:
  • MagPro X100 Series
EXPERIMENTAL: 2
Device: repetitive transcranial magnetic stimulation (rTMS)

1 Hz

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

Other Names:
  • MagPro X100 Series
Device: repetitive transcranial magnetic stimulation (rTMS)

20Hz

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

Other Names:
  • 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 Names:
  • MagPro X100 Series

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in CI produced by different frequency of stimulus and duration of treatments indicated by LICI, CSP and SICI
Time Frame: intermittent
intermittent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

April 11, 2008

First Submitted That Met QC Criteria

April 14, 2008

First Posted (ESTIMATE)

April 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 2, 2014

Last Update Submitted That Met QC Criteria

May 1, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 009/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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