NCT00658307

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2008

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 2, 2014

Status Verified

May 1, 2014

Enrollment Period

6.1 years

First QC Date

April 11, 2008

Last Update Submit

May 1, 2014

Conditions

Healthy

Keywords

repetitive transcranial magnetic stimulationdouble-blindsham-controlledrandomized

Outcome Measures

Primary Outcomes (1)

  • Changes in CI produced by different frequency of stimulus and duration of treatments indicated by LICI, CSP and SICI

    intermittent

Study Arms (3)

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)

Interventions

repetitive transcranial magnetic stimulation (rTMS)DEVICE

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

Also known as: MagPro X100 Series
1
sham repetitive transcranial magnetic stimulation (rTMS)DEVICE

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

Also known as: MagPro X100 Series
3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Links

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Jeff Daskalakis, MD, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Temerty Centre for Therapeutic Brain Intervention

Study Record Dates

First Submitted

April 11, 2008

First Posted

April 15, 2008

Study Start

April 1, 2008

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 2, 2014

Record last verified: 2014-05

Locations

CA(1)