Research
Clinical Trials
Ongoing and Upcoming Studies
Utilizing Changes in Human Brain Connectivity to Establish a Dose-Response Relationship Involved in the Therapeutic Actions of Prefrontal Brain Stimulation on Depression Symptoms
ClinicalTrials.gov Identifier: NCT04243798
As described above, we recently developed a new form of rTMS called accelerated intermittent theta burst stimulation (aiTBS), also known as SAINT. Active stimulation but not sham was highly effective for treatment-resistant depression in a relatively small, randomized, double-blind, clinical trial, with an antidepressant response in 5 days for most patients. In this larger follow-up study, we will further assess the effectiveness of this treatment. We also will obtain multiple functional MRIs, EEGs, and other measures of brain function to better understand how SAINT works and determine the relationship(s) among baseline depression, dose of rTMS, and therapeutic response. We are looking to recruit 100 participants between the ages of 22-65 with treatment-resistant depression. This study will be a double-blind study. Participants will be randomized into two groups to receive either active or sham (placebo equivalent) rTMS.
Neuroimaging Biomarkers for Predicting rTMS Response in OCD
ClinicalTrials.gov Identifier: NCT04286126
We are currently leading a multi-site study to examine the efficacy of a new form of Repetitive transcranial magnetic stimulation (rTMS), accelerated theta-burst, to treat OCD in adults. Previous research indicates two stimulation targets may be effective in treating OCD: the dorsomedial prefrontal cortex (DMPFC) and the orbitofrontal cortex (OFC). Patients often show a strong response to one target but not in 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.
All participants in our study will receive stimulation in both sites. 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. Following a two-week course of stimulation, participants will then cross over and receive stimulation at the other site. In addition to stimulation, participants will receive both fMRI and EEG imaging throughout the course of the study to measure baseline and changes in networks associated with OCD. We hope the results from this study will improve our understanding of individualized treatment response and the underlying neurocircuitry associated with that response.
We are currently recruiting adults 18 and older to participate. Please follow the link below to confirm your interest in the study and complete screening questionnaires.
Please reach out to: tmsocdstudy@stanford.edu for more information
A Pilot Trial Refining the Protocol for the Use of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Use Disorder: Testing Two Different Treatment Locations and NeuroImaging Based Targeting.
Clinicaltrials.gov identifier: NCT05720312
With a push towards legalization across the country, more and more people are using marijuana (cannabis). Many people use marijuana with minimal ill effects, but a subset of people who use it develop a dysfunctional use pattern where the ill effects of their use outweigh the effects they consider beneficial. This condition, medically termed cannabis use disorder (CUD), is similar to other addictive disorders such as alcohol use disorder and tobacco use disorder. Those with CUD by definition suffer substantial personal, occupational, and/or health adverse effects, and despite these adverse effects often have difficulty quitting on their own.
As a medical community we currently do not have any established medication to treat CUD, and our psychotherapies are only moderately effective. Thankfully an understanding of the brain circuit abnormalities associated with CUD have led to several potential treatment strategies. One such treatment strategy is to increase the strength of the so-called ‘self-control’, or ‘cognitive-control’ network in relation to resisting marijuana use and another treatment strategy is to decrease the over-reactivity of the ’reward’ network in response to marijuana. There have been several studies showing that each strategy has the potential to help people reduce their use of substances if they have a substance use disorder, including a recent study we completed in CUD (attempting to increase the strength of the ‘cognitive-control’ network).
In this study we are hoping to work with a group of people who are suffering from CUD and are interested in quitting, or substantially reducing the amount of marijuana they use. We are studying the effects of the two different study-treatment strategies using repetitive Transcranial Magnetic Stimulation (rTMS)–one form of rTMS that we think strengthens the ‘cognitive-control’ network in relation to marijuana, and another form of rTMS that we think decreases the over-reactivity of the ‘reward-network’ to marijuana. All participants additionally receive an established psychotherapy. We will be trying to learn if one treatment strategy works better than the other, whether we can use magnetic resonance imaging (MRI) to precisely target the study treatment, and whether we can use MRI to predict whether an individual might respond better to one of the strategies.
The use of rTMS, much like we will use it in this study, is cleared by the Food and Drug Administration (FDA) for the treatment of Major Depressive Disorder, Obsessive Compulsive Disorder, and smoking cessation. It subsequently has a long safety track record (it is thought to be safe and has few side effects) and is well known to provide long lasting benefit in the conditions it is cleared for. There are no thinking or memory side effects associated with rTMS and it does not appear to change normally functioning brain networks.
If you are wanting to quit using or substantially reduce your use of marijuana, this study might be right for you. For more information on the study please feel free to reach out to our study team at (650) 800-6920 or quitmarijuana@stanford.edu.
Accelerated Theta Burst Stimulation for Inpatients with Bipolar Disorder
This study intends to utilize an accelerated iTBS (aiTBS) treatment approach for inpatients suffering from bipolar disorder in a manic episode. Intermittent theta-burst stimulation (iTBS) is a patterned form of repetitive transcranial magnetic stimulation (rTMS), FDA-approved neuromodulatory treatment for refractory major depressive disorder (MDD). rTMS trials have also shown that right DLPFC TMS is effective for manic symptoms of bipolar disorder. Accelerated rTMS paradigms have become of increasing clinical interest to overcome the limitations of long duration of standard rTMS. Accelerated iTBS has been shown to be effective within just 5 days allowing treatment to be delivered during an acute psychiatric hospitalization which have an average duration of 10 days. We will utilize a modified design of the protocol used in our lab’s recent publication: Cole et al., American Journal of Psychiatry, 2020.
We aim to recruit a total of 30 inpatients participants for an open-label pilot study (aged 22-80 year old) using intermittent theta burst stimulation (iTBS) over the right dorsolateral prefrontal cortex (RDLPFC) (up to five days, 10x/day). Participants will be required to meet diagnostic criteria for Bipolar I or Bipolar II (without unmanageable psychosis), in a current state of hypomania/mania.
Modulating Probabilities: Prediction, Assessment, and Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder with rTMS
This project aims to measure and modulate a mood depressive episode (MDE) in hospitalized patients with borderline personality disorder (BPD) and comorbid mood depressive disorder (MDD) or bipolar disorder II (BAD II) in a current mood depressive episode (MDE). This study will test the antidepressant effect of aiTBS stimulation over the left dorsolateral prefrontal cortex (L-DLPFC), and aiTBS stimulation over the dorsomedial prefrontal cortex (DMPFC) compared with sham.
