Due to the COVID-19 outbreak and current shelter in place ordinence, Clinical Trials have been suspended. As more information becomes available we will update our website when studies can resume.
please refer to Stanord Medicine official COVID-19 updates for more information and resources
Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) Stimulation for Depressive Symptoms
This is a follow up study to the recently published Stanford accelerated intelligent neuromodulation therapy for treatment-resistant depression (SAINT-TRD) ClinicalTrials.gov Identifier: NCT03240692
Repetitive transcranial magnetic stimulation (rTMS) is effective at inducing antidepressant responses in patients with treatment-resistant depression. Initial studies suggest that rTMS could be effective at inducing antidepressant responses transdiagnostically but responses typically take two to four weeks. A new type of rTMS, intermittent theta-burst stimulation (iTBS), has been shown to be five times more potent than traditional rTMS. More potent stimulation means patients can be stimulated for less time, meaning more sessions could be administered per day, potentially resulting in much faster antidepressant responses.
This study proposes a novel approach for targeting depressive symptoms, aiming to induce antidepressant responses within five days. We are looking to recruit 100 participants age 22-65 with treatment resistant depression (has failed at least one anti-depressant medication). This study will be a double blinded study. Participants will be randomized into two groups. Participants will recieve either Active and Sham (Placebo) TMS.
Clinical Trials are currently on hold. However if you are interested in this study and would like to be on a wait list for when the study is able to begin, please go to this link https://is.gd/stanford_atbs_study and complete the questionnaire.
Neuroimaging Biomarkers for Predicting rTMS Response in OCD
|ClinicalTrials.gov Identifier: NCT04286126|
We are doing this research study to find if a new form of Repetitive transcranial magnetic stimulation (rTMS) is an effective in treating OCD. So far, at least two stimulation targets have consistent evidence of efficacy in OCD: the dorsomedial prefrontal cortex (DMPFC) and the orbitofrontal cortex (OFC). Patients often show a strong response to one target but not the other. It is not well understood why some patients respond, while others do not. So far, there are no biomarkers for predicting treatment response, identifying the optimal neuroanatomical target, or choosing between treatments.
This study evaluates an accelerated schedule of theta-burst stimulation using a Transcranial Magnetic Stimulation (TMS) device for treatment-resistant Obsessive Compulsive Disorder (OCD). In a randomized fashion, half the participants will receive accelerated theta-burst stimulation at the dorsomedial prefrontal cortex (DMPFC), while half will receive accelerated theta-burst stimulation at the right orbitofrontal (rOFC) site.
Bilateral Accelerated Theta Burst in Treatment-Resistant Bipolar Depression: A Biomarker Study
We are doing this research study to find out if a new form of repetitive transcranial magnetic stimulation (rTMS) is effective in treating treatment-resistant bipolar depression. rTMS is approved by the U.S. Food and Drug Administration (FDA) for the treatment of MDD in adults with depression that have not benefited from medication. This FDA-approved treatment involves stimulating the left frontal area of the head with an electromagnet that produces a magnetic field delivered in short bursts. These bursts are focused on an area of the brain that is thought to be involved in causing depression. As the magnet rapidly turns on and off, the electrical currents in the brain tend to synchronize with the magnet. TMS has been shown to help some patients with depression.
In this study, we are looking at a new way of using intermittent TBS to treat treatment-resistant bipolar depression. The name of this new procedure is “accelerated intermittent theta-burst stimulation (aiTBS)”. aiTBS involves using shorter periods of stimulation over multiple treatments received each day for five days. We hope to learn if this shorter type of TMS is effective in treating bipolar depression. This open-label pilot study will be conducted with 30 patients who will receive active aiTBS treatment.
While Clinicial Trials are currently on hold, if you would like to be on a wait list for when Clinical Trials start Please fill out or online pre-screening form here https://is.gd/bipolar_screening_atbs and fill out all the questionnaires.
Establishing Imaging Biomarkers for Spaced Theta-Burst Stimulation
We plan to use functional magnetic resonance imaging (fMRI) methods to assess brain changes following spaced theta burst stimulation (TBS), a new form of repetitive transcranial magnetic stimulation (rTMS), in 10 healthy participants. We will measure the effects of both excitatory (intermittent, iTBS) and inhibitory (continuous, cTBS) TBS applied to the motor cortex, a system that when stimulated produces a readily observable behavioral response (e.g., movement of a given body region). In addition to brain activity, during tasks and at rest change following the applications of spaced cTBS and iTBS. Additionally, the aim is to determine the duration of the spaced TBS effects on brain activity and behavior. This study will provide an understanding of the functional brain and behavioral changes that occur following spaced TBS to the motor cortex and has implications for reducing the long treatment schedules associated with classical rTMS protocols.
Accelerated Theta Burst stimulation for Treatment of Alcohol Use Disorder
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive procedure and an established technology. Research in patients with alcohol use disorder has shown some promising results. 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, such as using accelerated intermittent theta-burst stimulation (aTBS), to reduce treatment times with possible enhanced efficacy with some preliminary success.This study intends to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.
The Effect of Cortisol Administration on Neural Correlates of Emotion in Depression
The subgenual cingulate is an area of the brain is known to be hyperactive in patients with depression and to normalize with successful treatment. The hormone cortisol has been shown to inhibit the subgenual cingulate in healthy subjects during some types of emotion processing. Depressed patients are thought to have reduced sensitivity to cortisol. In this study we attempt to inhibit the subgenual cingulate of depressed patients by giving extra cortisol in the form of orally administered hydrocortisone.
Attenuation of Antidepressant Effects of Ketamine by Opioid Receptor Antagonism
Objective: In addition to N-methyl-D-aspartate receptor antagonism, ketamine produces opioid system activation. The objective of this study was to determine whether opioid receptor antagonism prior to administration of intravenous ketamine attenuates its acute antidepressant or dissociative effects.
Method: In a proposed double-blind crossover study of 30 adults with treatment-resistant depression, the authors performed a planned interim analysis after studying 14 participants, 12 of whom completed both conditions in randomized order: placebo or 50 mg of naltrexone preceding intravenous infusion of 0.5 mg/kg of ketamine. Response was defined as a reduction >=50% in score on the 17-item Hamilton Depression Rating Scale (HAM-D) score on postinfusion day 1.
Results: In the interim analysis, seven of 12 adults with treatment-resistant depression met the response criterion during the ketamine plus placebo condition. Reductions in 6-item and 17-item HAM-D scores among participants in the ketamine plus naltrexone condition were significantly lower than those of participants in the ketamine plus placebo condition on postinfusion days 1 and 3. Secondary analysis of all participants who completed the placebo and naltrexone conditions, regardless of the robustness of response to ketamine, showed similar results. There were no differences in ketamine-induced dissociation between conditions. Because naltrexone dramatically blocked the antidepressant but not the dissociative effects of ketamine, the trial was halted at the interim analysis.
Conclusions: The findings suggest that ketamine’s acute antidepressant effect requires opioid system activation. The dissociative effects of ketamine are not mediated by the opioid system, and they do not appear sufficient without the opioid effect to produce the acute antidepressant effects of ketamine in adults with treatment-resistant depression.
Am J Psychiatry 2018; 175:1–11; doi: 10.1176/appi.ajp.2018.18020138
Use of Repetitive Transcranial Magnetic Stimulation to Augment Hypnotic Analgesia
NIH/NCCIH Grant # 1R33AT009305-01
ClinicalTrials.gov ID: NCT02969707
We will be using function neuroimaging (fMRI) to understand the brain systems affected when hypnosis and hypnotic analgesia are augmented with repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation to 100 people with fibromyalgia, a chronic pain condition. The investigators will measure the effect of rTMS-augmentation on the brain networks underlying hypnotizability, as well as the effect of rTMS-augmentation on hypnotic analgesia networks. We hope to demonstrate that a combination of these psychological and neuromodulatory treatments will be more effective than hypnosis alone, thereby enhancing the depth of hypnosis, range of hypnosis and the efficacy of hypnotic analgesia and hopefully creating a new treatment modality for individuals suffering from pain syndromes such as fibromyalgia pain.
This study has completed recruitment.
If you would like to speak to a member of our study team, please contact us at:
650-736-2233 or firstname.lastname@example.org
Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study
This research study is looking for ninety-five people with depression to enroll at Stanford University.
A new treatment for depression involves stimulating the brain with an electromagnet placed on the scalp that rapidly turns on and off. This treatment is called transcranial magnetic stimulation. As the magnet rapidly turns on and off, the electrical currents in the brain tend to synchronize with the magnet. Brief treatments with this appear to help patients with depression.
This study is looking for participants that have depression with a history of being unresponsive to at least one medication, that might respond to this new treatment. This new treatment is looking at a new way of using transcranial magnetic stimulation to treat depression and is called theta burst stimulation. It involves using a shorter period of stimulation for each treatment, which might benefit patients. We hope to learn if this shorter type of transcranial magnetic stimulation is effective in treating depression.