This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant bipolar depression. In this open-label study, all participants will receive accelerated theta-burst stimulation.
Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 minutes over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful in real-world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session over 4-6 weeks). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. In a recent study, the investigators applied this accelerated paradigm in individuals with treatment-resistant depression (TRD), which showed a significant antidepressant effect (90% remission rate). Additionally, 3 participants from this study carried a bipolar TRD diagnosis and responded at minimum, equally as well, with no adverse events experienced or manic/hypomanic conversion observed during the treatment series. This study intends to further modify the parameters to create a more rapid form of this treatment for bipolar TRD, and look at the change in clinical measures and neuroimaging biomarkers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
All participants will receive accelerated intermittent theta-burst stimulation to the left DLPFC. Treatment will be targeted by utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance. Stimulation will be delivered to left DLPFC using the MagPRo stimulator.
Stanford University
Palo Alto, California, United States
Change From Baseline Montgomery Asberg Depression Rating Scale (MADRS)
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS consists of ten questions. Each interview question is rated from 0 to 6 with an overall score of 60 or less. Higher scores indicate increasing depressive symptoms. A total score of 0 to 6 indicates the absents of depressive symptoms, 7 to 19 indicates mild depressive symptoms, 30 to 34 indicates moderate depressive symptoms, 35 to 60 indicates severe depressive symptoms.
Time frame: Baseline and immediately post-treatment (6 days post baseline)
Change From Baseline Young Mania Rating Scale (YMRS)
The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. The overall total score is a maximum of 60. Typical YMRS baseline scores can vary a lot. They depend on the patients' clinical features such as mania (YMRS = 12), depression (YMRS = 3), or euthymia (YMRS = 2).
Time frame: Baseline and immediate post-treatment (6 days post baseline)
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