160 Participants Needed

Brain Stimulation for PTSD

WL
Overseen ByWen Li, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to develop and test a novel pathophysiology of PTSD by integrating sensory cortical (SC) and amygdala-PFC dysfunctions into a tripartite Sensory-Prefrontal-Cortex-Amygdala (SPA) model.

Will I have to stop taking my current medications?

If you are taking calcium channel blockers or alpha-blockers, you will need to stop these medications for 48 hours before the scan. For other medications, the protocol does not specify, but you should have medication stability for the past 2 months if you are taking psychotropic medications.

Is brain stimulation using tRNS and tACS safe for humans?

Transcranial random noise stimulation (tRNS) and transcranial alternating current stimulation (tACS) are non-invasive brain stimulation methods that have been used in studies on human brain function and behavior. These methods are generally considered safe, as they involve low-intensity electrical currents and have been used in various research settings without significant safety concerns.12345

How does the treatment alpha-frequency tACS differ from other treatments for PTSD?

Alpha-frequency tACS is unique because it uses electrical currents to enhance brain wave patterns, specifically alpha oscillations, which are linked to relaxation and reduced anxiety. This non-invasive treatment can increase connectivity in the brain and reduce symptoms of anxiety, offering a novel approach compared to traditional PTSD treatments like medication or talk therapy.14678

What data supports the effectiveness of the treatment alpha-frequency tACS for PTSD?

Research shows that alpha-frequency tACS can increase brain connectivity and reduce anxiety, which may help with PTSD. Additionally, a similar treatment, cranial electrotherapy stimulation (CES), has been reported by veterans to improve PTSD symptoms by 62.5%.1491011

Who Is on the Research Team?

WL

Wen Li, PhD

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

This trial is for right-handed individuals aged 18-50 with normal vision and smell, who meet specific safety criteria. Participants must have a PTSD diagnosis and if on psychotropic meds, they should be stable for the last 2 months. Substance users must abstain for 48 hours before the experiment.

Inclusion Criteria

Right-handed
If having mild substance use disorder (for patients) or occasional substance use, abstention from use 48 hours before the experiment.
Meeting the tACS screening criteria (e.g., lack of a serious head injury or loss of consciousness)
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Exclusion Criteria

Regularly drinking 3 or more alcoholic beverages a day
Concurrent Axis I diagnosis (depression, anxiety, and mild substance use disorder are allowed given their high comorbidity with PTSD)
Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior that poses an immediate danger to self or others
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tACS or RNS stimulation and undergo EEG-fMRI recordings

Immediate pre- to post-stimulation

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • alpha-frequency tACS
  • Random noise stimulation
Trial Overview The study tests a new theory of PTSD involving sensory cortex and amygdala-PFC dysfunctions by using two brain stimulation techniques: alpha-frequency tACS (transcranial alternating current stimulation) and random noise stimulation.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: With PTSD for studyExperimental Treatment2 Interventions
Group II: Health controls for studyActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials
234
Recruited
41,100+

Published Research Related to This Trial

In a study involving 25 participants, it was found that decreasing the intensity of transcranial alternating current stimulation (tACS) from 1.0 mA to 0.4 mA switched the effect from excitation to inhibition of cortical excitability in the primary motor cortex.
The research demonstrated that different intensities of high-frequency transcranial electrical stimulation can selectively control the enhancement or reduction of motor cortex excitability, with 140 Hz tACS producing stronger inhibition than transcranial random noise (tRNS).
Close to threshold transcranial electrical stimulation preferentially activates inhibitory networks before switching to excitation with higher intensities.Moliadze, V., Atalay, D., Antal, A., et al.[2016]
Transcranial alternating current stimulation (tACS) is a promising non-invasive brain stimulation technique that can reset disturbed brain oscillations, potentially improving behavioral outcomes in psychiatric disorders, with initial studies showing no serious adverse events.
The review highlights that tACS may serve not only as a therapeutic tool but also as a diagnostic aid for psychiatric conditions, suggesting its dual role in both treatment and understanding of mental health issues.
Transcranial alternating current stimulation (tACS): from basic mechanisms towards first applications in psychiatry.Elyamany, O., Leicht, G., Herrmann, CS., et al.[2023]
Transcranial alternating current stimulation (tACS) at alpha frequencies (8-12 Hz) applied over four days significantly enhanced long-range alpha connectivity in the brain, which lasted more than 24 hours after treatment, indicating potential for lasting neural changes.
This increase in connectivity was associated with reduced anxiety and improved perception of sensory stimuli, suggesting that tACS could be a promising intervention for psychiatric disorders linked to abnormal neural oscillations.
Lasting connectivity increase and anxiety reduction via transcranial alternating current stimulation.Clancy, KJ., Baisley, SK., Albizu, A., et al.[2019]

Citations

Close to threshold transcranial electrical stimulation preferentially activates inhibitory networks before switching to excitation with higher intensities. [2016]
Transcranial alternating current stimulation (tACS): from basic mechanisms towards first applications in psychiatry. [2023]
Lasting connectivity increase and anxiety reduction via transcranial alternating current stimulation. [2019]
Defining focal brain stimulation targets for PTSD using neuroimaging. [2022]
Military service member and veteran self reports of efficacy of cranial electrotherapy stimulation for anxiety, posttraumatic stress disorder, insomnia, and depression. [2015]
Using noise for the better: The effects of transcranial random noise stimulation on the brain and behavior. [2022]
Electrophysiological evaluation of high and low-frequency transcranial random noise stimulation over the auditory cortex. [2021]
Comparison of the effects of transcranial random noise stimulation and transcranial direct current stimulation on motor cortical excitability. [2015]
Modulation of auditory gamma-band responses using transcranial electrical stimulation. [2021]
Alpha transcranial alternating current stimulation reduces depressive symptoms in people with schizophrenia and auditory hallucinations: a double-blind, randomized pilot clinical trial. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Alpha Power Increase After Transcranial Alternating Current Stimulation at Alpha Frequency (α-tACS) Reflects Plastic Changes Rather Than Entrainment. [2022]
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