66 Participants Needed

cTBS for PTSD

Recruiting at 1 trial location
JS
MB
Overseen ByMichael Borich, PhD
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to potentially prevent PTSD (post-traumatic stress disorder) using a non-invasive brain stimulation technique called continuous theta burst stimulation (cTBS). The researchers aim to determine if disrupting memory processing in the brain shortly after a traumatic event can lower fear responses and reduce PTSD risks. Participants will receive either actual cTBS or a sham (placebo) version during the study. The study seeks individuals with PTSD who have no history of neurological diseases or major head trauma. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research in PTSD prevention.

Do 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.

What prior data suggests that continuous theta burst stimulation (cTBS) is safe for use in this study?

Research has shown that continuous theta burst stimulation (cTBS), a type of brain stimulation, is generally safe. Although the FDA has approved it only for treating depression, studies are exploring its use for other conditions like PTSD. Most people tolerate it well, and serious side effects rarely occur. Some might experience mild discomfort or a slight headache, but these symptoms usually resolve quickly. Overall, cTBS seems to be a promising, non-invasive option with a good safety record.12345

Why are researchers excited about this trial?

Researchers are excited about continuous theta burst stimulation (cTBS) for PTSD because it represents a novel approach that targets the brain's sensory cortex during critical periods of memory processing. Unlike traditional treatments for PTSD, such as psychotherapy or medication like SSRIs, which often take weeks to show results, cTBS has the potential to disrupt maladaptive neural patterns swiftly. By using transcranial magnetic stimulation, cTBS aims to alter brain activity in specific areas linked to fear and memory, offering a targeted and potentially faster-acting alternative to current options.

What evidence suggests that continuous theta burst stimulation (cTBS) might be an effective treatment for PTSD?

Research has shown that continuous theta burst stimulation (cTBS) might help reduce PTSD symptoms. This technique is part of a broader method known as TMS, which has shown promise in easing PTSD by targeting specific brain areas. In this trial, some participants will receive active cTBS, while others will receive sham cTBS as a placebo comparator. Studies suggest that cTBS can improve brain cell communication, potentially alleviating PTSD symptoms. Although more research is needed, these findings indicate that cTBS could be a promising way to manage PTSD.16789

Who Is on the Research Team?

MB

Michael R Borich, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Ability to provide informed consent
Willingness to participate in study
I have no history of muscle, bone, or nerve diseases.
See 1 more

Exclusion Criteria

Adults unable to consent, individuals who are not yet adults, pregnant women, and prisoners on scientific grounds and to minimize risk.
Participants that have a history of major head trauma, a neurodegenerative disorder, or recent (<6 months) substance abuse
I am within the specified age range for the trial.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo fMRI scans and are randomly assigned to receive either active or sham continuous theta burst stimulation (cTBS) to disrupt neural activity in the sensory cortex during the memory consolidation window.

2 days
2 visits (in-person)

Follow-up

Participants are monitored for changes in neural connections and physiological responses after treatment.

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Continuous theta burst stimulation (cTBS)
  • Sham continuous theta burst stimulation (cTBS)
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: cTBS: Inhibitory Transcranial magnetic stimulation (TMS) to sensory CortexExperimental Treatment1 Intervention
Group II: Sham cTBSPlacebo Group1 Intervention

Continuous theta burst stimulation (cTBS) is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Continuous theta burst stimulation for:
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Approved in European Union as Continuous theta burst stimulation for:
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Approved in Canada as Continuous theta burst stimulation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Published Research Related to This Trial

A study involving 50 veterans with PTSD showed that intermittent theta-burst stimulation (iTBS) significantly improved social and occupational functioning after 2 weeks, indicating its potential efficacy as a treatment for PTSD.
One month after treatment, iTBS demonstrated significant reductions in both clinician- and self-rated PTSD symptoms, as well as improvements in depression and functioning, suggesting that iTBS could be a promising new approach for managing PTSD.
Theta-Burst Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder.Philip, NS., Barredo, J., Aiken, E., et al.[2020]
The study found that continuous theta-burst stimulation (cTBS) can effectively reduce cortical excitability, but its effects show limited reproducibility across sessions, indicating variability in its impact.
Among the neurophysiological markers assessed, the modulation of corticospinal excitability measured 5 minutes after cTBS was the most consistent, suggesting it could be a reliable measure for future research on cTBS effects.
Reproducibility of the effects of theta burst stimulation on motor cortical plasticity in healthy participants.Vernet, M., Bashir, S., Yoo, WK., et al.[2022]
In a study involving 46 veterans with PTSD, those who received 4 weeks of active intermittent theta burst stimulation (iTBS) had significantly better long-term outcomes, with a mean relapse time of 296 days compared to 182 days for those who received only 2 weeks of active treatment.
The study suggests that greater exposure to active iTBS is associated with reduced clinical relapse rates and that neuroimaging of brain connectivity may help predict long-term treatment outcomes.
One-year clinical outcomes following theta burst stimulation for post-traumatic stress disorder.Petrosino, NJ., Wout-Frank, MV'., Aiken, E., et al.[2021]

Citations

Transcranial Magnetic Stimulation for Post-traumatic Stress ...Transcranial Magnetic Stimulation (TMS) is a technique used in treating PTSD and involves stimulating specific portions of the brain through electromagnetic ...
Theta Burst Transcranial Magnetic Stimulation for ...Intermittent theta-burst stimulation (iTBS) is a new, more rapid administration protocol with data supporting efficacy in depression.
Transcranial magnetic stimulation as a treatment for ...TMS shows potential as a treatment for PTSD, although further research is required to understand the neurological mechanisms of TMS on specific PTSD symptoms.
Non-invasive brain stimulation for posttraumatic stress ...One-year clinical outcomes following theta burst stimulation for post-traumatic stress disorder. Neuropsychopharmacology https://doi.org ...
New brain stimulation technique shows promise in easing ...A new study found that a form of brain stimulation that can rapidly improve communication between neurons in the brain helped ease PTSD symptoms.
Repetitive transcranial magnetic stimulation for post‐traumatic ...To assess the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for the treatment of post‐traumatic stress disorder (PTSD) in adults.
Theta -Burst Neuromodulation for PTSD (TBS)The purpose of the proposed study is to evaluate initial feasibility and efficacy of Theta Burst Transcranial Magnetic Stimulation (TBS) as an adjunct treatment ...
Transcranial Magnetic Stimulation and Cranial Electrical ...5 Hz repetitive transcranial magnetic stimulation for posttraumatic stress disorder comorbid with major depressive disorder. J Affect Disord. 2018;235:414 ...
Synchronized transcranial magnetic stimulation for ...These results support the feasibility, tolerability and potential efficacy of sTMS for comorbid PTSD and MDD.
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