tACS for Anxiety Disorders

Overseen By Gerald Tramontano, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: NeuroCognitive and Behavioral Institute Clinical Research Foundation

Disqualifiers: Neurodegenerative, Epilepsy, Pregnancy, Schizophrenia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 3-4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help individuals with anxiety disorders, such as generalized anxiety disorder, social anxiety, separation anxiety in children, and PTSD. The treatment uses transcranial alternating current stimulation (tACS), a non-invasive technique that gently stimulates the brain to potentially ease anxiety symptoms. Participants will receive either the real tACS treatment or a sham version, with the option to try the actual treatment later. Those with long-standing anxiety disorders that impact daily life may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in anxiety treatment.

Do I need to stop my current medications to join the trial?

The trial requires that your current medications for non-excluded conditions have been stable for at least eight weeks before joining. If your medications are stable, you likely won't need to stop them.

What prior data suggests that transcranial alternating current stimulation (tACS) is safe for treating anxiety disorders?

Research has shown that transcranial alternating current stimulation (tACS) is generally safe and well-tolerated. A study on its use in teenagers found that tACS had few side effects, similar to those in the group that did not receive it, suggesting safety for younger people and, by extension, adults. Another review found that tACS could help treat mental health issues without serious side effects. Although specific data on anxiety patients is limited, these findings suggest tACS is a safe option for trial participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for anxiety?

Researchers are excited about transcranial alternating current stimulation (tACS) for anxiety disorders because it offers a non-invasive way to modulate brain activity. Unlike traditional treatments such as medication, which often target neurotransmitters, tACS uses electrical currents to directly influence brainwave patterns. This approach could potentially reduce side effects associated with medications and provide a new option for those who haven't responded well to existing therapies. Additionally, tACS can be tailored to individual brain activity, offering a personalized treatment strategy.

What evidence suggests that transcranial alternating current stimulation (tACS) is effective for anxiety disorders?

Research has shown that transcranial alternating current stimulation (tACS) can help reduce anxiety symptoms. In this trial, participants will divide into two groups: an active group receiving tACS and a sham group receiving a placebo treatment. Studies have found that using tACS at a frequency of 5 Hz on specific brain areas can effectively ease anxiety. This method has shown promise as a quick way to relieve anxiety in early research. It targets brain areas linked to anxiety, aiming to reduce its intensity. While more studies are needed, initial results suggest that tACS could be a helpful tool for people with anxiety disorders. ^{3 6 7 8 9}

Who Is on the Research Team?

Gerald Tramontano

Principal Investigator

NCI Clinical Research Foundation

Are You a Good Fit for This Trial?

This trial is for individuals aged 5 or older with anxiety disorders like GAD, SAD, PTSD, and separation anxiety. Participants must meet specific diagnostic criteria and be stable on any current medications or psychotherapy. They should have a caregiver if needed and no medical conditions that could interfere with the study.

Inclusion Criteria

Clinical laboratory values of TSH and T4, within 90 days from randomization must be within normal limits or judged not clinically related by the physician sub-investigator or PI to the subject's cognitive impairment if abnormalities are present

My medications for other health conditions have been stable for 8 weeks.

I started psychotherapy at least 2 months before joining the study.

Exclusion Criteria

Pregnancy or lactation

Cardiac pacemakers or other implanted biomedical devices

Active suicidal tendency (evaluated by Columbia-Suicide Severity Rating Scale [C-SSRS], traditional version). Note: If the BDI or CDS of the participants significantly increase, the CSSRS will be repeated

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 25 minutes of 5 Hz transcranial alternating current stimulation (tACS) titrated up to 2mA targeting the anterolateral amygdala across 12 treatment sessions

3-4 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

What Are the Treatments Tested in This Trial?

Interventions

• transcranial alternating current stimulation (tACS)

Trial Overview

The trial tests transcranial alternating current stimulation (tACS) at 5 hz up to 2mA targeting the brain's amygdala over 12 sessions within a month. It aims to see if tACS can reduce anxiety symptoms compared to sham (placebo-like) treatment, followed by an optional phase where everyone receives tACS.

How Is the Trial Designed?

Group I: Active group Experimental Treatment 1 Intervention

Group II: Sham group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

NeuroCognitive and Behavioral Institute Clinical Research Foundation

Lead Sponsor

Trials

1

Recruited

40+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11345433/

Immediate and long-term efficacy of transcranial direct current ...

The results of meta-analysis suggested that tDCS reduced the severity of general anxiety symptoms in OCD, PTSD and ADs, with a high effect size ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0304394024002271

Neural consequences of 5-Hz transcranial alternating ...

Transcranial alternating current stimulation (tACS) at 5-Hz to the right hemisphere can effectively alleviate anxiety symptoms.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39477076/

Efficacy and acceptability of brain stimulation for anxiety ...

The study results suggest that BSTs are effective treatments for anxiety disorders, OCD and PTSD; lf-rTMS may be considered as the most promising option.

4.

nature.com

nature.com/articles/s41398-024-03003-w

Evaluating the effects of tDCS on depressive and anxiety ...

tDCS over the left DLPFC is effective in reducing depressive symptoms and shows promising effects in alleviating anxiety symptoms among individuals with ...

5.

medrxiv.org

medrxiv.org/content/10.1101/2023.10.17.23296812v1.full

Tripod transcranial alternating current stimulation at 5-Hz to ...

Conclusion The results suggest the potential of this novel tripod tACS design as a rapid anxiety alleviator and the importance of a clinical ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7867505/

Transcranial alternating current stimulation (tACS): from basic ...

tACS is a unique form of non-invasive brain stimulation. Sinusoidal alternating electric currents are delivered to the scalp to affect mostly cortical neurons.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07185451

Efficacy and Safety of Transcranial Alternating Current ...

To assess adverse events and side effects in both the intervention and control groups, ensuring the safety and tolerability of tACS in adolescent populations.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9720798/

Transcranial alternating current stimulation and its effects on ...

This systematic review and meta-analysis is the first to critically evaluate the effect of TACS on cognition and the treatment of psychiatric disorders. TACS ...

9.

brainstimjrnl.com

brainstimjrnl.com/article/S1935-861X(24)00974-4/fulltext

Effects of theta transcranial alternating current ...

The study will provide new insights into the potential of theta-tACS as an easily implementable method to improve the recovery of patients with post-traumatic ...