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 and 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.
Participants will receive iTBS to bilateral 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
Change in Hamilton Depression Rating Scale 21-Item Score
A 21 item clinical assessment tool used to rate a patient's level of depression. The total scores range from 0 to 63 with higher scores indicating worse depression.
Time frame: Difference between baseline and follow up at one month after the final aiTBS treatment (on day 5)
Change in Hamilton Rating Scale for Depression (HAMD-17)
The HAMD-17 is a 17-item rating scale questionnaire administered by clinicians to rate a patient's level of depression . The total scores range from 0 to 52 with higher scores indicating worse depression.
Time frame: Baseline, immediately post treatment, 2 weeks post treatment, 4 weeks post treatment
Change in The Scale for Suicide Ideation
A rating scale that measures the current intensity of specific attitudes, behaviors, and plans to commit suicide. The total scores range from 0 to 38 with higher scores indicating greater suicidality.
Time frame: Baseline, immediately post treatment, 2 weeks post treatment, 4 weeks post treatment
Change in Hamilton Rating Scale for Depression (HAMD-6)
The HAMD-6 is a shorter, six-item version of the Hamilton Depression Rating Scale (HAMD-D) that measures core symptoms of major depressive disorder, such as depressed mood, guilt and anxiety. The total scores range from 0 to 22 with higher scores indicating worse depression.
Time frame: Every day of stimulation on days (visits) 1, 2, 3, 4, and 5
Change From Baseline Functional Connectivity Within the Default Mode Network.
We will assess functional connectivity as seen on resting state fMRI within the default mode network.
Time frame: Baseline, immediately post-treatment, 4 weeks post-treatment
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Change From Baseline Functional Connectivity of Subcallosal Cingulate Cortex and the Default Mode Network.
We will assess functional connectivity as seen on resting state fMRI of subcallosal cingulate cortex to the default mode network.
Time frame: Baseline, immediately post-treatment, 4 weeks post-treatment
Change in Beck Depression Inventory (BDI)
The Beck Depression Inventory (BDI) is a 21-item self-report questionnaire used to measure the severity of depression symptoms. The total scores range from 0 to 63 with higher scores indicating worse depression.
Time frame: Baseline, immediately post-treatment, 4 weeks post-treatment
Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS (Montgomery-Åsberg Depression Rating Scale) is a 10-item diagnostic tool used by clinicians to assess the severity of depression by scoring symptoms on a 0-60 scale with higher scores indicating worse depression.
Time frame: Baseline, immediate post-treatment, 4 weeks post-treatment