Bipolar Affective Disorder
Conditions
Keywords
Transcranial Magnetic Stimulation, TMS
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.
Interventions
DEVICETranscranial 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 -
Sponsors
Queen's University, Kingston, Ontario
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Bipolar Depression * no physical health problems
Exclusion criteria
* Metal in head/neck or skull * History of Epilepsy * Pregnancy * Pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare antidepressant efficacy of right, left to sham | within 9 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To determine if QEEG activity correlates with antidepressant response to rTMS | within 9 weeks |
| To determine if non-responders can become responders if treating the opposite hemisphere | within 9 weeks |
Countries
Canada
Outcome results
None listed