Transcranial Magnetic Stimulation in Bipolar Depression (TMS)

August 2, 2011 updated by: St. Joseph's Healthcare Hamilton

A Randomized, Sham Controlled, Crossover Trial of rTMS for Bipolar Depression

To compare antidepressant efficacy of left or right to sham Repetitive Transcranial Magnetic Stimulation (rTMS)

to determine if non-responders can become responders if treated on the other side of the hemisphere

(rTMS)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be assigned to one of 3 treatment arms for 10 days of treatment with either left high frequency or right high frequency, or sham rTMS. After 10 days of treatment, and no improvement, another 10 days of treatment follows, this time with the coil placed on the other hemisphere. Subjects will be followed for 2 months respectively with unrestricted treatment provided by their regular physician. Mood stabilizers will be continued throughout this trial.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

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
      • Hamilton, Ontario, Canada, L8N 3K7
        • St. Joseph's Healthcare, rTMS Laboratory, Mood Disorder Program, 100 West Fifth Street

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bipolar Depression
  • no physical health problems

Exclusion Criteria:

  • Metal in head/neck or skull
  • History of Epilepsy
  • Pregnancy
  • Pacemaker

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: 1, Phase l, True or Sham
this treatment will be True or Sham (placebo) on one side of the head, phase I
Device: Transcranial Magnetic Stimulation (TMS)

Phase l clients receive either True or Sham TMS treatments on left or right side of head for 10 days.

Phase ll clients will receive either Sham or True TMS treatments on the other side of the head - the same type as in phase l -

Other Names:
  • VAS
  • HamD
  • BDI II
Active Comparator: 2, phase ll, Sham or True
This treatment will be Sham(placebo)or True on the other side of the head phase II.
Device: Transcranial Magnetic Stimulation (TMS)

Phase l clients receive either True or Sham TMS treatments on left or right side of head for 10 days.

Phase ll clients will receive either Sham or True TMS treatments on the other side of the head - the same type as in phase l -

Other Names:
  • VAS
  • HamD
  • BDI II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare antidepressant efficacy of right, left to sham
Time Frame: within 9 weeks
within 9 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine if QEEG activity correlates with antidepressant response to rTMS
Time Frame: within 9 weeks
within 9 weeks
To determine if non-responders can become responders if treating the opposite hemisphere
Time Frame: within 9 weeks
within 9 weeks

Collaborators and Investigators

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

Sponsor

St. Joseph's Healthcare Hamilton

Collaborators

Queen's University, Kingston, Ontario

Investigators

  • Principal Investigator: Gary Hasey, MD, McMaster University

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

July 1, 2002

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

August 3, 2011

Last Update Submitted That Met QC Criteria

August 2, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMS2092

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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