This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In a double-blind fashion, half the participants will receive accelerated theta-burst stimulation while half will receive sham treatment.
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 effective in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session, 5 days per week, for 4-8 weeks). Recently, researchers have pursued modifying the treatment parameters to reduce treatment times with some preliminary successes. This study aims to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite 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 using a MagPro stimulator.
The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
Patients will have the option of receiving active, open label aTBS treatment following sham. Stimulation will be delivered to the L-DLPFC using a MagPro stimulator or Nexstim TMS device.
Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine
Stanford, California, United States
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from pre-treatment to 1-month post-treatment.
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.
Time frame: Pretreatment to 1-month posttreatment
Percentage change in the Hamilton Rating Scale for Depression (HAMD-17)
A provider administered questionnaire used to assess remission and recovery from depression.
Time frame: 4 weeks posttreatment
Percentage change in the Columbia Suicide Severity Rating Scale (C-SSRS)
A suicidal ideation rating scale created by researchers at Columbia University.
Time frame: Pretreatment, immediately posttreatment, 2 weeks posttreatment, 4 weeks posttreatment
Percentage change in the Hamilton Rating Scale for Depression (HAM-6)
A 6 item questionnaire used to score the severity of depression.
Time frame: Follow-up every 2 weeks for 6 months by telephone
Percentage change in the Hamilton Rating Scale for Depression (HAMD-17)
A provider administered questionnaire used to assess remission and recovery from depression.
Time frame: Pretreatment, immediately posttreatment, 2 weeks posttreatment
Change in baseline functional connectivity to immediate post-treatment using functional MRI
MR imaging of the brain to measure the functional connectivity between the subcallosal cingulate to the default mode network.
Time frame: Pretreatment to immediately posttreatment
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Change in baseline functional connectivity to 1-month post-treatment
The investigators 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 to 1-month post-treatment
Change in baseline heart rate variability through immediate post treatment and 1-month post treatment
Heart rate variability measures will be compared baseline, immediate post treatment and 1-month post treatment
Time frame: Pretreatment, immediately posttreatment and 1-month post treatment