This study evaluates the effectiveness of re-treatment using accelerated schedule of intermittent theta-burst stimulation for treatment-resistant depression. This is an open label study.
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 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study will investigate the efficacy of a further modified protocol, creating a more rapid form of the treatment and look at the change in neuroimaging biomarkers. In particular, this study will determine the efficacy of re-treatment in individuals who have already experienced benefit of the accelerated protocol to ensure results can be repeated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Participants will receive iTBS to the left DLPFC or bilateral DLPFC, to the right and left DLPFC. The DLPFC will be targeted utilizing either Localite's neuronavigation system or Nexstim's eField neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004). Stimulation will be delivered to the L-DLPFC or bilateral DLPFC using either a MagVenture MagPro X100 or a Nexstim TMS device.
Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine
Palo Alto, California, United States
Percentage change in Hamilton Depression Rating Scale 21-Item score
A 21 item clinical assessment tool used to rate a patient's level of depression - total scores range from 0-63 with higher scores indicating worse depression
Time frame: Difference between baseline and one month after aiTBS treatment
Change in Hamilton Rating Scale for Depression (HAMD-17)
A provider administered questionnaire used to rate a patient's level of depression - total scores range from 0-52 with higher scores indicating worse depression
Time frame: Pretreatment, immediately posttreatment, 2 weeks posttreatment, 4 weeks posttreatment
Change in The Scale for Suicide Ideation
A rating scale that measures the current intensity of specific attitudes, behaviors, and plans to commit suicide - total scores range from 0-38 with higher scores indicating greater suicidality
Time frame: Pretreatment, immediately posttreatment, 2 weeks posttreatment, 4 weeks posttreatment
Change in Hamilton Rating Scale for Depression (HAMD-6)
rate a patient's level of depression - total scores range from 0-22 with higher scores indicating worse depression
Time frame: Every day of stimulation, follow-up every 2 weeks after treatment for 6 months by telephone]
Change from baseline functional connectivity
We will assess functional connectivity as seen on resting state fMRI, between the subcallosal cingulate to the default mode network and within the default mode network.
Time frame: Pretreatment, immediately post-treatment, 4 weeks post-treatment
Change in Beck Depression Inventory (BDI)
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Self-report measure of depressive symptoms - total scores range from 0-63 with higher scores indicating worse depression
Time frame: Pretreatment, immediately post-treatment, 4 weeks post-treatment
Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
A 10 item clinician rated measure of depressive symptoms - total scores range from 0-60 with higher scores indicating worse depression
Time frame: Pretreatment, immediately post-treatment, 4 weeks post-treatment