300 Participants NeededMy employer runs this trial

Temporal Interference for Anxiety and PTSD

RJ
AS
Overseen ByAlisha Sylvester
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?

This trial explores a new method called temporal interference (TI) to understand its effects on the brain in individuals with anxiety and PTSD. TI is a type of neuromodulation that uses electrical stimulation to influence brain activity. Participants will receive either active TI stimulation or a sham (inactive) version for comparison. Individuals who have experienced anxiety or PTSD and are fluent in English might be suitable candidates. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research in neuromodulation for mental health.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that may increase the risk of seizures, such as bupropion, varenicline, chlorpromazine, and theophylline.

What prior data suggests that this neuromodulation method is safe for individuals with anxiety and stress-related conditions?

Research has shown that temporal interference (TI) stimulation is generally safe and well-tolerated. Studies have found it does not cause significant heat stress or swelling in the brain. Most reported side effects are mild and temporary, such as tingling sensations or slight discomfort, which are common with this type of brain stimulation. Recommendations suggest that when used within certain safety limits, TI stimulation poses no risk. This non-invasive method targets deep brain areas without causing harm, making it a promising option for further research.12345

Why are researchers excited about this trial?

Researchers are excited about Temporal Interference (TI) stimulation for anxiety and PTSD because it offers a novel way to target brain activity non-invasively. Unlike current treatments such as medications and cognitive behavioral therapy, which often involve systemic effects or require extensive time commitments, TI uses overlapping electrical fields to stimulate specific brain regions without affecting surrounding areas. This precision could lead to more effective symptom relief with fewer side effects. Additionally, the potential for rapid symptom improvement during the intervention sessions makes TI a promising option for those who need quick relief from anxiety and PTSD symptoms.

What evidence suggests that temporal interference is effective for anxiety and PTSD?

Research has shown that temporal interference (TI) stimulation, a non-invasive brain technique, may help reduce anxiety and stress-related symptoms. This method uses electrical currents to target deep brain areas without affecting the surface. In this trial, participants will receive either active TI stimulation or sham TI stimulation. One study found that TI stimulation can enhance brain responses linked to positive feelings and reduce anxiety levels. Early results also suggest that TI stimulation might aid in treating mood disorders like depression. It is considered safe and well-tolerated, making it a promising option for those with anxiety and PTSD.56789

Who Is on the Research Team?

NF

Negar Fani, PhD, ABPP

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-65, both men and women, who do not have moderate to severe drug use or serious medical conditions. People with certain metal implants, a history of seizures or head injury, current stimulant use, pregnancy, or those unable to undergo MRI scans cannot participate.

Inclusion Criteria

Fluent English speaker
Written informed consent
I am between 18 and 65 years old, of any sex or ethnic background.
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Exclusion Criteria

I am not pregnant, breastfeeding, or trying to become pregnant.
Contraindications to MRI scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia, as assessed with the standard MRI screening form from the CABI, FERN or CSI
I am able to speak and understand English well.
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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 Temporal Interference (TI) stimulation or sham stimulation during 5 intervention sessions, with each session lasting 20-60 minutes.

5 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using various assessments including MRI, EEG, and self-report questionnaires.

6 weeks
2-5 visits (virtual)

Ecological Momentary Assessment (optional)

Participants may opt into daily assessments over a 4-week period to track mood and behavior in real-world settings.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Temporal Interference

Trial Overview

The study tests a new brain stimulation method called temporal interference (TI) using an electrical device. It aims to see how TI affects the brain and behavior in healthy people and those with anxiety or stress-related disorders.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Temporal Interference (TI) stimulationExperimental Treatment1 Intervention
Group II: Sham TI stimulationPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Citations

Novel NIBS in psychiatry: Unveiling TUS and TI for research ...

Previous studies combining brain stimulation techniques with therapy, such as rTMS with exposure therapy have shown promising results in anxiety ...

Temporal Interference Electrical Stimulation for ...

In this review, we summarize the principles and technical characteristics of TI stimulation and highlight its recent applications in mood and stress-related ...

Efficacy and Safety Assessment of Temporal Interference ...

The aim of this study was to explore the efficacy and safety of temporal interference stimulation to improve bipolar depression, as well as to explore the ...

Preliminary findings from an ongoing clinical trial

Temporal interference (TI) stimulation is a non-invasive deep brain stim- ... Results: Neuroimaging data indicated significant variability in target.

Focus on Temporal Interference Stimulation

Transcranial electrical stimulation with temporal interference (TES-TI) is a noninvasive technique that uses multiple high-frequency carrier ...

Recommendations for the Safe Application of Temporal ...

We propose frequency-dependent thresholds below which TIS voltages and currents are unlikely to pose a risk to humans.

Study Details | NCT07558759 | Temporal Interference in ...

This study aims to evaluate the preliminary efficacy of TI stimulation in healthy populations and in individuals with anxiety and stress-related ...

Safety Recommendations for Temporal Interference ...

AEs related to electrical stimulation reported in the PMS data for the categories Nervous System, Mental Emotional and Behavioral Disorders, ...

Safety assessment of temporal interference stimulation - PMC

Temporal interference (TI) stimulation did not induce a significant thermal stress or inflammatory response in the hippocampus. (A) Representative images ...