cTBS for PTSD
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Emory University
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This project represents a unique collaborative opportunity to pursue the essential proof-of-principle demonstration that non-invasive interference of sensory cortical memory consolidation shortly after an emotional experience can attenuate the cued fear response and potentially reduce the risk of developing post-traumatic stress disorder (PTSD). If successful, the study results would anchor a potential advance in the treatment of patients after a traumatic event and seed future animal and clinical studies of emotional sensory cortical memory consolidation to reduce the prevalence and negative sequelae of PTSD.
Is continuous theta burst stimulation (cTBS) a promising treatment for PTSD?
Yes, continuous theta burst stimulation (cTBS) is a promising treatment for PTSD. It is a new and faster form of transcranial magnetic stimulation (TMS) that can help reduce symptoms by affecting brain activity. This method has shown potential in treating PTSD and other conditions like depression and anxiety.
13578What safety data exists for cTBS treatment for PTSD?
The safety of theta burst stimulation (TBS), including continuous theta burst stimulation (cTBS), has been reviewed in the literature. A systematic review found that most adverse events were mild and occurred in about 5% of subjects. Although TBS has a theoretical risk of seizures due to high-frequency bursts, it is generally considered safe and efficacious. However, caution is advised due to its novelty, and there is a need for more rigorous documentation of adverse events and studies on seizure risk. Additionally, a comparative study on pediatric subjects suggests that the safety profile of TBS is still being evaluated.
12457What data supports the idea that cTBS for PTSD is an effective treatment?
The available research shows that continuous theta burst stimulation (cTBS) can be an effective treatment for PTSD. One study found that veterans who received more active sessions of a similar treatment, intermittent theta burst stimulation (iTBS), had better outcomes over a year compared to those who received fewer sessions. This suggests that cTBS, which is a variant of TMS, might also help reduce PTSD symptoms. While the research primarily focuses on iTBS, the positive results indicate that cTBS could be similarly beneficial.
35679Do I need to stop taking my current medications to join the trial?
Yes, you must stop taking any current psychoactive medications to participate in the trial.
Eligibility Criteria
This trial is for adults who can consent and have been clinically diagnosed with PTSD. They should be willing to participate and not have musculoskeletal or neurological diseases. It's not for those with TMS or MRI contraindications, minors, pregnant women, prisoners, people outside the age range set by the study, those with dementia signs, on psychoactive meds recently, major head trauma survivors, neurodegenerative disorder patients or recent substance abusers.Participant Groups
The trial tests if disrupting memory consolidation using non-invasive brain stimulation (cTBS) after a traumatic event can lessen fear responses and lower PTSD risk. Participants will receive either real cTBS or a sham (fake) treatment to compare effects on fear memories.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: cTBS: Inhibitory Transcranial magnetic stimulation (TMS) to sensory CortexExperimental Treatment1 Intervention
Participants will undergo a Functional magnetic resonance imaging (fMRI) scan while performing a fear conditioning/extinction task at the Center for Systems Imaging- Emory University Hospital (CSI-EUH) and then either stay at CSI-EUH or relocate to the Neural Plasticity Research Laboratory at Emory Rehabilitation Hospital. Participants will then be randomly assigned to either receive active or sham continuous theta burst stimulation (cTBS) to transiently disrupt neural activity in the targeted sensory cortex region specifically during the sensory memory consolidation window.
Group II: Sham cTBSPlacebo Group1 Intervention
Participants will undergo a Functional magnetic resonance imaging (fMRI) scan while performing a fear conditioning/extinction task at CSI-EUH and then either stay at CSI-EUH or relocate to the Neural Plasticity Research Laboratory at Emory Rehabilitation Hospital. Participants will then be randomly assigned to either receive active or sham continuous theta burst stimulation (cTBS) to transiently disrupt neural activity in the targeted sensory cortex region specifically during the sensory memory consolidation window.
Continuous theta burst stimulation (cTBS) is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Continuous theta burst stimulation for:
- Treatment-resistant depression
- Research for PTSD and anxiety disorders
🇪🇺 Approved in European Union as Continuous theta burst stimulation for:
- Treatment-resistant depression
- Research for various neurological conditions
🇨🇦 Approved in Canada as Continuous theta burst stimulation for:
- Treatment-resistant depression
- Research for neurological and psychiatric conditions
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Emory Rehabilitation HospitalAtlanta, GA
Emory University HospitalAtlanta, GA
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Who is running the clinical trial?
Emory UniversityLead Sponsor
References
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
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).
Reproducibility of the effects of theta burst stimulation on motor cortical plasticity in healthy participants. [2022]Theta-burst stimulation (TBS) is a repetitive transcranial magnetic stimulation (TMS) protocol, capable of enhancing or suppressing the amplitude of contralateral motor-evoked potentials (MEP) for several minutes after stimulation over the primary motor cortex. Continuous TBS (cTBS) produces a long-term depression (LTD)-like reduction of cortical excitability. The purpose of this study was to assess the test-retest reproducibility of the effects of cTBS and to investigate which neurophysiologic markers of cTBS-induced plasticity are most reproducible.
Safety and tolerability of theta burst stimulation vs. single and paired pulse transcranial magnetic stimulation: a comparative study of 165 pediatric subjects. [2020]Although single- and paired-pulse (sp/pp) transcranial magnetic stimulation (TMS) studies are considered minimal risk in adults and children, the safety profile for theta-burst TMS (TBS) is unknown.
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.
One-year clinical outcomes following theta burst stimulation for post-traumatic stress disorder. [2021]Theta burst transcranial magnetic stimulation (TBS) is a potential new treatment for post-traumatic stress disorder (PTSD). We previously reported active intermittent TBS (iTBS) was associated with superior clinical outcomes for up to 1-month, in a sample of fifty veterans with PTSD, using a crossover design. In that study, participants randomized to the active group received a total of 4-weeks of active iTBS, or 2-weeks if randomized to sham. Results were superior with greater exposure to active iTBS, which raised the question of whether observed effects persisted over the longer-term. This study reviewed naturalistic outcomes up to 1-year from study endpoint, to test the hypothesis that greater exposure to active iTBS would be associated with superior outcomes. The primary outcome measure was clinical relapse, defined as any serious adverse event (e.g., suicide, psychiatric hospitalization, etc.,) or need for retreatment with repetitive transcranial magnetic stimulation (rTMS). Forty-six (92%) of the initial study's intent-to-treat participants were included. Mean age was 51.0 ± 12.3 years and seven (15.2%) were female. The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79. Mean days to relapse were 296.0 ± 22.1 in the 4-week group, and 182.0 ± 31.9 in the 2-week group. When used, rTMS retreatment was generally effective. Exploratory neuroimaging revealed default mode network connectivity was predictive of 1-year outcomes (corrected p
Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder and Major Depression: Comparing Commonly Used Clinical Protocols. [2022]Transcranial magnetic stimulation (TMS) is increasingly being used to treat posttraumatic stress disorder (PTSD) comorbid with major depressive disorder (MDD). Yet, identifying the most effective stimulation parameters remains an active area of research. We recently reported on the use of 5 Hz TMS to reduce PTSD and MDD symptoms. A recently developed form of TMS, intermittent theta burst stimulation (iTBS), appears noninferior for treating MDD. Because iTBS can be delivered in a fraction of the time, it provides significant logistical advantages; however, evaluations of whether iTBS provides comparable PTSD and MDD symptom reductions are lacking. We performed a retrospective chart review comparing clinical outcomes in veterans with PTSD and MDD who received iTBS (n = 10) with a matched cohort that received 5-Hz TMS (n = 10). Symptoms were evaluated using self-reported rating scales at baseline and every five treatments for up to 30 sessions. Both protocols were safe and reduced symptoms, ps
Clinical effects of continuous theta burst stimulation for generalized anxiety disorder and a mechanism involving α oscillations: a randomized controlled trial. [2022]Continuous theta burst stimulation (cTBS) is a much more rapid protocol than low-frequency repetitive transcranial magnetic stimulation (rTMS), but no clinical trial has yet investigated the efficacy and mechanisms of cTBS for the treatment of generalized anxiety disorder. The purpose of this study was to compare the clinical effects and α oscillations induced by cTBS versus 1 Hz rTMS as predictors of response, and to assess the underlying mechanisms of the therapeutic effects of cTBS in patients with generalized anxiety disorder.
Accelerated theta-burst transcranial magnetic stimulation of the bilateral dorsolateral prefrontal cortex in a patient with post-traumatic stress disorder and major depressive disorder: Case report. [2023]Theta-burst transcranial magnetic stimulation has demonstrated promising effectiveness as treatment for post-traumatic stress disorder (PTSD) and depression. However, the effect of accelerated theta-burst stimulation (TBS) in comorbid with PTSD and depression remains unknown.