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Transcranial Magnetic Stimulation in Bipolar Depression (TMS)

Primary Purpose

Bipolar Affective Disorder

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (TMS)
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Affective Disorder focused on measuring Transcranial Magnetic Stimulation, TMS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Bipolar Depression no physical health problems Exclusion Criteria: Metal in head/neck or skull History of Epilepsy Pregnancy Pacemaker

Sites / Locations

  • St. Joseph's Healthcare, rTMS Laboratory, Mood Disorder Program, 100 West Fifth Street

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

1, Phase l, True or Sham

2, phase ll, Sham or True

Arm Description

this treatment will be True or Sham (placebo) on one side of the head, phase I

This treatment will be Sham(placebo)or True on the other side of the head phase II.

Outcomes

Primary Outcome Measures

To compare antidepressant efficacy of right, left to sham

Secondary Outcome Measures

To determine if QEEG activity correlates with antidepressant response to rTMS
To determine if non-responders can become responders if treating the opposite hemisphere

Full Information

First Posted
September 13, 2005
Last Updated
August 2, 2011
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Queen's University, Kingston, Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT00186758
Brief Title
Transcranial Magnetic Stimulation in Bipolar Depression
Acronym
TMS
Official Title
A Randomized, Sham Controlled, Crossover Trial of rTMS for Bipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Queen's University, Kingston, Ontario

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Affective Disorder
Keywords
Transcranial Magnetic Stimulation, TMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1, Phase l, True or Sham
Arm Type
Sham Comparator
Arm Description
this treatment will be True or Sham (placebo) on one side of the head, phase I
Arm Title
2, phase ll, Sham or True
Arm Type
Active Comparator
Arm Description
This treatment will be Sham(placebo)or True on the other side of the head phase II.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (TMS)
Other Intervention Name(s)
HamD, BDI II, VAS
Intervention Description
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 -
Primary Outcome Measure Information:
Title
To compare antidepressant efficacy of right, left to sham
Time Frame
within 9 weeks
Secondary Outcome Measure Information:
Title
To determine if QEEG activity correlates with antidepressant response to rTMS
Time Frame
within 9 weeks
Title
To determine if non-responders can become responders if treating the opposite hemisphere
Time Frame
within 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Bipolar Depression no physical health problems Exclusion Criteria: Metal in head/neck or skull History of Epilepsy Pregnancy Pacemaker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Hasey, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare, rTMS Laboratory, Mood Disorder Program, 100 West Fifth Street
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3K7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Transcranial Magnetic Stimulation in Bipolar Depression

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