Brain Stimulation for PTSD
Recruiting in Palo Alto (17 mi)
Overseen byLily A Brown, PhD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Pennsylvania
Disqualifiers: Pregnancy, Seizure disorder, Claustrophobia, others
Trial Summary
What is the purpose of this trial?This study will be the first of its kind to explore the impact of continuous theta burst stimulation (cTBS) to the intraparietal sulcus (IPS) on arousal symptoms among patients with posttraumatic stress disorder (PTSD). The investigators will demonstrate that IPS cTBS results in significant reduction in arousal (measured by startle response) compared to sham cTBS, that IPS cTBS interacts with extinction training to further improve arousal, and that there is a dose/response effect of cTBS on arousal. The investigators will also demonstrate that IPS cTBS significantly improves retention of extinction learning, the experimental analogue of exposure therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those who have had recent medication changes in the past 8 weeks. This might mean you need to be stable on your current medications for at least 8 weeks before joining.
What data supports the effectiveness of the treatment Continuous Theta Burst Stimulation for PTSD?
Research suggests that intermittent theta burst stimulation (iTBS), a form of brain stimulation, has shown promise in improving symptoms of PTSD and depression. Studies indicate that iTBS can change brain connectivity patterns, which may help reduce PTSD symptoms.
12345Is theta burst stimulation (TBS) safe for humans?
Theta burst stimulation (TBS) has been studied for various psychiatric conditions and is generally considered safe, with most adverse effects being mild. However, there is a theoretical risk of seizures, so it should be used with caution, and more research is needed to fully understand its long-term safety.
12467How is continuous theta burst stimulation different from other PTSD treatments?
Continuous theta burst stimulation (cTBS) is a unique treatment for PTSD that uses magnetic pulses to stimulate specific brain areas, offering a novel approach compared to traditional therapies like medication or talk therapy. It is a form of transcranial magnetic stimulation (TMS) that is faster and has shown promise in improving symptoms of depression and PTSD, especially in cases where other treatments have not been effective.
12489Eligibility Criteria
This trial is for right-handed adults aged 18-60 with PTSD, as diagnosed by the DSM-5 criteria. Participants must not have any metal implants in their body.Inclusion Criteria
No metal implants
I am between 18 and 60 years old.
Right-handed
+1 more
Exclusion Criteria
Any medical condition that increases risk for fMRI or cTBS
Claustrophobia
Non-English speaking
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive continuous theta burst stimulation (cTBS) to the intraparietal sulcus (IPS) and undergo extinction training to reduce arousal symptoms
5 weeks
Multiple visits including Days 4, 5, 34, and 35
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of startle response and subjective distress
4 weeks
Participant Groups
The study tests if a brain stimulation technique called Continuous Theta Burst Stimulation (cTBS) to the Intraparietal Sulcus can reduce arousal symptoms in PTSD patients compared to sham (fake) treatment.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Continuous theta burst stimulation to the intraparietal sulcusExperimental Treatment1 Intervention
Continuous theta burst stimulation will be delivered to the individually targeted intraparietal sulcus site at 100% RMT.
Group II: Sham continuous theta burst stimulationPlacebo Group1 Intervention
We will use the coil's electric stimulation functionality that allows for the delivery of a brief electric pulse to the scalp simultaneous to the pulse to mimic actual stimulation.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Center for the Treatment and Study of Anxiety, University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?
University of PennsylvaniaLead Sponsor
References
Exploring Theta Burst Stimulation for Post-traumatic Stress Disorder in Australian Veterans-A Pilot Study. [2021]Post-traumatic stress disorder (PTSD) is a severe and debilitating condition affecting a significant proportion of the veteran community. A substantial number of veterans with PTSD fail to benefit from trauma-focused psychological therapies or pharmacotherapy or are left with residual symptoms, and therefore, investigation of new and innovative treatment is required. Theta Burst Stimulation (TBS) is a novel form of Repetitive Transcranial Magnetic Stimulation, which has been shown to improve depression symptoms and associated cognitive deficits. The current pilot study aimed to explore the acceptability, safety, and tolerability of intermittent TBS (iTBS) as a treatment for PTSD in Australian veterans.
Theta-Burst Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder. [2020]Posttraumatic stress disorder (PTSD) is a highly prevalent psychiatric disorder associated with disruption in social and occupational function. Transcranial magnetic stimulation (TMS) represents a novel approach to PTSD, and intermittent theta-burst stimulation (iTBS) is a new, more rapid administration protocol with data supporting efficacy in depression. The authors conducted a sham-controlled study of iTBS for PTSD.
Dorsomedial prefrontal theta burst stimulation to treat anhedonia, avolition, and blunted affect in schizophrenia or depression - a randomized controlled trial. [2021]Intermittent theta burst stimulation (iTBS) over the dorsomedial prefrontal cortex (DMPFC) has shown promise in open-label trials of depression.
Changes in functional connectivity after theta-burst transcranial magnetic stimulation for post-traumatic stress disorder: a machine-learning study. [2022]Intermittent theta burst stimulation (iTBS) is a novel treatment approach for post-traumatic stress disorder (PTSD), and recent neuroimaging work indicates that functional connectivity profiles may be able to identify those most likely to respond. However, prior work has relied on functional magnetic resonance imaging, which is expensive and difficult to scale. Alternatively, electroencephalography (EEG) represents a different approach that may be easier to implement in clinical practice. To this end, we acquired an 8-channel resting-state EEG signal on participants before (n = 47) and after (n = 43) randomized controlled trial of iTBS for PTSD (ten sessions, delivered at 80% of motor threshold, 1,800 pulses, to the right dorsolateral prefrontal cortex). We used a cross-validated support vector machine (SVM) to track changes in EEG functional connectivity after verum iTBS stimulation. We found that an SVM classifier was able to successfully separate patients who received active treatment vs. sham treatment, with statistically significant findings in the Delta band (1-4 Hz, p = 0.002). Using Delta coherence, the classifier was 75.0% accurate in detecting sham vs. active iTBS, and observed changes represented an increase in functional connectivity between midline central/occipital and a decrease between frontal and central regions. The primary limitations of this work are the sparse electrode system and a modest sample size. Our findings raise the possibility that EEG and machine learning may be combined to provide a window into mechanisms of action of TMS, with the potential that these approaches can inform the development of individualized treatment methods.
Mechanisms and applications of theta-burst rTMS on the human motor cortex. [2009]Theta-burst Stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation (rTMS). Applied over the primary motor cortex it has been successfully used to induce changes in cortical excitability. The advantage of this stimulation paradigm is that it is able to induce strong and long lasting effects using a lower stimulation intensity and a shorter time of stimulation compared to conventional rTMS protocols. Since its first description, TBS has been used in both basic and clinical research in the last years and more recently it has been expanded to other domains than the motor system. Its capacity to induce synaptic plasticity could lead to therapeutic implications for neuropsychiatric disorders. The neurobiological mechanisms of TBS are not fully understood at present; they may involve long-term potentiation (LTP)- and depression (LTD)-like processes, as well as inhibitory mechanisms modulated by GABAergic activity. This article highlights current hypotheses regarding the mechanisms of action of TBS and some central factors which may influence cortical responses to TBS. Furthermore, previous and ongoing research performed in the field of TBS on the motor cortex is summarized.
Safety and Efficacy of Theta-Burst Stimulation in the Treatment of Psychiatric Disorders: A Review of the Literature. [2019]Theta-burst stimulation (TBS) is a form of repetitive transcranial magnetic stimulation and is thought to induce more rapid and longer-lasting effects on synaptic plasticity than conventional repetitive transcranial magnetic stimulation protocols. TBS is being used as an investigational and more recently as a therapeutic tool. The purpose of this review is to describe and discuss the studies that have evaluated the safety and efficacy of this technique in the treatment of various psychiatric disorders such as depression, schizophrenia, obsessive-compulsive disorder, Tourette's disorder, nicotine and cocaine addiction, and pathological gambling. Studies have reported mild adverse effects but no cases of seizures or mania. Despite the fact that studies were heterogeneous in terms of design and results, some of them are promising mostly for treatment-resistant depression and auditory hallucinations. Future well-designed sham-controlled studies are needed to confirm the long-term safety and efficacy of TBS in the treatment of such conditions.
Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. [2022]Theta burst stimulation (TBS) protocols have recently emerged as a method to transiently alter cortical excitability in the human brain through repetitive transcranial magnetic stimulation. TBS involves applying short trains of stimuli at high frequency repeated at intervals of 200 milliseconds. Because repetitive transcranial magnetic stimulation is known to carry a risk of seizures, safety guidelines have been established. TBS has the theoretical potential of conferring an even higher risk of seizure than other repetitive transcranial magnetic stimulation protocols because it delivers high-frequency bursts. In light of the recent report of a seizure induced by TBS, the safety of this new protocol deserves consideration. We performed an English language literature search and reviewed all studies published from May 2004 to December 2009 in which TBS was applied. The adverse events were documented, and crude risk was calculated. The majority of adverse events attributed to TBS were mild and occurred in 5% of subjects. Based on this review, TBS seems to be a safe and efficacious technique. However, given its novelty, it should be applied with caution. Additionally, this review highlights the need for rigorous documentation of adverse events associated with TBS and intensity dosing studies to assess the seizure risk associated with various stimulation parameters (e.g., frequency, intensity, and location).
A Secondary Analysis on Effects of Theta Burst Transcranial Magnetic Stimulation to Reduce Anger in Veterans With Posttraumatic Stress Disorder. [2022]Anger is an important clinical feature of posttraumatic stress disorder (PTSD) that can hamper recovery. We recently reported that intermittent theta burst stimulation (iTBS) demonstrated preliminary efficacy to reduce symptoms of posttraumatic stress disorder and major depression; here, we performed a secondary analysis testing whether iTBS reduced symptoms of anger over the course of iTBS treatment and compared to sham stimulation.
Neurochemical effects of theta burst stimulation as assessed by magnetic resonance spectroscopy. [2022]Continuous theta burst stimulation (cTBS) is a novel transcranial stimulation technique that causes significant inhibition of synaptic transmission for