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Transcranial Magnetic Stimulation in Bipolar Depression (TMS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00186758
First Posted: September 16, 2005
Last Update Posted: August 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Queen's University, Kingston, Ontario
Information provided by:
St. Joseph's Healthcare Hamilton
  Purpose

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)


Condition Intervention Phase
Bipolar Affective Disorder Device: Transcranial Magnetic Stimulation (TMS) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Sham Controlled, Crossover Trial of rTMS for Bipolar Depression

Resource links provided by NLM:


Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • To compare antidepressant efficacy of right, left to sham [ Time Frame: within 9 weeks ]

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

Estimated Enrollment: 40
Study Start Date: July 2002
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • HamD
  • BDI II
  • VAS
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:
  • HamD
  • BDI II
  • VAS

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bipolar Depression
  • no physical health problems

Exclusion Criteria:

  • Metal in head/neck or skull
  • History of Epilepsy
  • Pregnancy
  • Pacemaker
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186758


Locations
Canada, Ontario
St. Joseph's Healthcare, rTMS Laboratory, Mood Disorder Program, 100 West Fifth Street
Hamilton, Ontario, Canada, L8N 3K7
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Queen's University, Kingston, Ontario
Investigators
Principal Investigator: Gary Hasey, MD McMaster University
  More Information

Responsible Party: Dr. Gary Hasey, Director, TMS Laboratory, McMaster University
ClinicalTrials.gov Identifier: NCT00186758     History of Changes
Other Study ID Numbers: TMS2092
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: August 3, 2011
Last Verified: August 2011

Keywords provided by St. Joseph's Healthcare Hamilton:
Transcranial Magnetic Stimulation
TMS

Additional relevant MeSH terms:
Depression
Bipolar Disorder
Mood Disorders
Genetic Diseases, X-Linked
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Genetic Diseases, Inborn