Brain Stimulation for Post-Traumatic Stress Disorder

Overseen By Jada Malveaux, MA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Psychoactive, Calcium channel, Alpha-blockers

Disqualifiers: Major medical illness, Neurological disorder, Severe psychiatric instability, Alcohol use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with PTSD (Post-Traumatic Stress Disorder) using Transcranial Alternating Current Stimulation (tACS), a form of brain stimulation. The goal is to determine if this technique can reduce symptoms like anxiety and constant alertness associated with PTSD. Participants will be divided into groups to receive either the real brain stimulation, a placebo version, or a different type of brain stimulation for comparison. This trial may suit individuals with PTSD who maintain stable medication use and can avoid alcohol and drugs for 48 hours before testing. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for PTSD.

Do I have to stop taking my current medications for the trial?

If you are taking psychotropic medications, you need to have been stable on them for the past 2 months. If you are on calcium channel blockers or alpha-blockers, you must stop them for 48 hours before the scan.

What prior data suggests that Transcranial Alternating Current Stimulation (tACS) is safe for treating PTSD?

Research shows that Transcranial Alternating Current Stimulation (tACS) is generally well-tolerated. Although specific studies on tACS for PTSD are not available here, similar brain stimulation methods have proven safe. For example, many individuals with PTSD have used Transcranial Direct Current Stimulation (tDCS), a similar technique, without major issues.

Information on Transcranial Random Noise Stimulation (tRNS) is less clear, but it is generally considered safe as a non-invasive brain stimulation method.

Overall, while individual experiences may vary, these brain stimulation techniques are usually regarded as safe with manageable side effects. Always consult a healthcare provider for personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Transcranial Alternating Current Stimulation (tACS) for treating Post-Traumatic Stress Disorder (PTSD) because it offers a non-invasive and potentially rapid way to modulate brain activity. Unlike traditional treatments like therapy or medication, which can take weeks or months to show effects, tACS uses electrical currents to target specific brain regions, possibly leading to faster improvements in symptoms. Additionally, this method avoids some side effects associated with medications, offering a promising alternative for individuals who may not respond well to existing treatments.

What evidence suggests that Transcranial Alternating Current Stimulation (tACS) is effective for PTSD?

Research has shown that Transcranial Alternating Current Stimulation (tACS), one of the treatments studied in this trial, might help reduce PTSD symptoms. Early results suggest that high-definition tACS can significantly ease these symptoms, making it a promising treatment option. tACS aims to alter brain activity to calm anxious feelings and reduce hypervigilance.

Another treatment arm in this trial involves Transcranial Random Noise Stimulation (tRNS). There is less direct evidence for tRNS in treating PTSD. However, similar brain stimulation methods have proven effective in managing PTSD symptoms by influencing brain areas related to mood and stress. Researchers are investigating whether tRNS can provide similar benefits. ^{1 2 3 4 6}

Who Is on the Research Team?

Wen Li, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for individuals experiencing anxiety or PTSD. Participants should be willing to undergo brain stimulation techniques like tACS and tRNS, which are non-invasive. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Right-handed

Meeting the tACS screening criteria (e.g., lack of a serious head injury or loss of consciousness)

With normal or corrected-to-normal vision and normal olfaction

Exclusion Criteria

I cannot stop taking my blood pressure medication for 2 days before a scan.

Failed Urine Drug Screening Test

Patients with concurrent Axis I diagnosis (depression, anxiety, and mild substance use disorder are allowed given their high comorbidity with PTSD)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tACS, sham tACS, or tRNS stimulation with simultaneous EEG/fMRI recordings and behavioral assessments

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Alternating Current Stimulation (tACS)

Trial Overview The study is testing the effects of Transcranial Alternating Current Stimulation (tACS) and Transcranial Random Noise stimulation (tRNS) on neural networks related to anxious arousal and hypervigilance in people with anxiety or PTSD.

How Is the Trial Designed?

Group I: Transcranial Alternating Current Stimulation (tACS) Experimental Treatment 1 Intervention

Group II: Active Control - Transcranial Random Noise stimulation (tRNS) Active Control 1 Intervention

Group III: Sham for Transcranial Alternating Current Stimulation (tACS) Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9193572/

Transcranial Magnetic Stimulation for Post-traumatic Stress ... In current studies, high-frequency stimulation has been shown to be more effective in PTSD rating scales posttreatment than low-frequency stimulation. The most ...

2. cpn.or.kr cpn.or.kr/view.html?uid=1820&vmd=Full

The Therapeutic Effect of High-definition 1-Hz Transcranial ... Conclusion: Preliminary findings suggest that HD-tACS in delta band can significantly alleviate PTSD symptoms, indicating its potential as a therapeutic ...

3. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2815835

Virtual Reality and Transcranial Direct Current Stimulation ... Active tDCS delivered during VR exposure significantly improved self-reported PTSD symptoms, reduced measures of autonomic arousal, and improved social ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032722009673

Research paper Treatment efficacy of tDCS and predictors ... This study highlighted the efficacy of frontal tDCS for the treatment of patients with PTSD and identified rumination and digit span as favorable predictive ...

5. nature.com nature.com/articles/s41398-020-0851-5

Non-invasive brain stimulation for posttraumatic stress ... Repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) hold promise for the treatment of posttraumatic stress ...

6. tandfonline.com tandfonline.com/doi/full/10.3402/ejpt.v2i0.5609

Full article: Brain stimulation in posttraumatic stress disorder A meta-analysis conducted at the Harvard School of Public Health concluded that CES was significantly more effective than sham treatment in improving anxiety ...