Recruiting

Temporal Interference

Sponsor:

Emory University

Code:

NCT07558759

Conditions

Anxiety

PTSD

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Electrical stimulation device

Electrical stimulation device

Study Details

Brief summary:

This study aims to understand the neural, behavioral and clinical effects of temporal interference (TI), a type of neuromodulation method, in healthy populations and in individuals with anxiety and stress-related conditions.

Conditions

Anxiety

PTSD

Study ID

NCT07558759

Start date

Apr 7, 2026

Status verified date

Jul, 2026

Completion date

Apr, 2031

Anticipated

Primary completion date

Apr, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Written informed consent.
  • Fluent English speaker.
  • Both sexes and all ethnic origins, between 18 and 65 years old.
  • Absence of current moderate to severe illicit drug use as assessed by subject history (AUDIT>=8 and/or DAST>2).

Exclusion Criteria:

  • Pregnant or currently breast-feeding women or any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant, as assessed by subject report and/or urine pregnancy screen.
  • 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.
  • Unable to fit comfortably in the scanner.
  • Contraindication to TI and/or TMS (including history of epilepsy, metallic implants in the head and/or neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers)
  • Current use of medications that may increase the risk of seizures (e.g., bupropion, varenicline, chlorpromazine, theophylline).
  • History or current serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, as assessed by subject history.
  • History of head injury resulting in more than brief loss of consciousness, as assessed by subject history.
  • Current cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine), as assessed by subject history.
  • Evidence of significant inconsistencies in self-report measures.
  • Non-English speakers will be excluded from this study because the research procedures rely heavily on the administration of validated self-report questionnaires, clinical interviews, and task instructions that at this time, are only available in English. Additionally, study staff are trained to administer these assessments and obtain informed consent in English only. Including non-English speakers would therefore pose a risk of misunderstanding study procedures, consent materials, or questionnaire items, which could affect both participant comprehension and data integrity.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Temporal Interference (TI) stimulation

Participants will receive active stimulation for each of 5 intervention sessions, and will receive TI stimulation for a total time of 20-60 minutes. Stimulation will occur during presentation of the visual stimuli on which subjects will conduct behavioral or cognitive tasks.

sham comparator: Sham TI stimulation

Participants will receive sham stimulation for each of 5 intervention sessions, where carrier frequency (e.g., 5000Hz) will be applied but no envelope frequency or 0Hz frequency will be applied.

Interventions

Electrical stimulation device

Temporal Interference (TI) stimulation is a non-invasive neuromodulation method which allows focal electrical stimulation of deep brain structures without affecting overlying cortical regions. Areas will be targeted based on tasks being administered under TI and will include areas associated with fear/anxiety expression and inhibition, reward, and general affective processing including cortical areas. Two carrier electric fields offset by a small amount (5-130Hz) will occur during stimulation.

Stimulation will be applied between the pairs of electrodes with a current up to a maximum of between 8mA (TI outside the scanner) and 10mA (TI inside the scanner) with envelope frequencies between 1hz-200hz. Multipolar TI will also be used with multiple locations that can be targeted for stimulation by adding more pairs of electrodes.

Electrical stimulation device

Electrodes will be placed in the same locations used for the TI intervention; either a carrier frequency or no electrical current will be delivered to the brain.

Primary outcome measure

  • Change in Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention ]
  • Change in State Trait Anxiety Inventory (STAI) [ Time Frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention ]
  • Change in Difficulties in Emotion Regulation Scale (DERS) Score [ Time Frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention ]
  • Change in PTSD Symptom Checklist (PCL-5) Score [ Time Frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention ]

Central Contacts and Locations

Central contacts

Rachel Jones

404-712-0354gtpaffectneurolab@emory.edu

Alisha Sylvester

alisha.marie.sylvester@emory.edu

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Rachel Jones

rachel.ivy.jones@emory.edu

Principal Investigator:

Negar Fani, PhD, ABPP

More Information

Sponsor

Emory University

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • Temporal Interference

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-07-15.