Temporal Interference for Anxiety and PTSD

This study is exploring a new, non-invasive brain stimulation method called Temporal Interference (TI) to treat anxiety and PTSD. TI uses electrical stimulation devices placed on the scalp to target specific deep brain areas without affecting the surface of the brain. Researchers want to see how TI affects brain activity, mood, and behavior in people with anxiety and stress-related conditions. To join, you must be between 18 and 65 years old, speak English fluently, and not be pregnant or breastfeeding. The study will measure changes in your anxiety levels using standard questionnaires like the Hamilton Anxiety Rating Scale (HAM-A) and the State Trait Anxiety Inventory (STAI) at different times after the intervention. The current recruitment status is unclear, and the study plans to enroll 300 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 300 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your anxiety levels will be measured at baseline, 2-5 weeks after the intervention, and 6 weeks after the intervention.

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NCT07558759

Temporal Interference in Psychiatry (TIP): Neuromodulation Using Temporal Interference

Recruiting
NAAges 18–65InterventionalBasic science
Emory University
~300 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Electrical stimulation device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Hamilton Anxiety Rating Scale (HAM-A)
Measured over Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
+3 more outcomes measured
Anxiety
PTSD
1 sites across 1 states
Georgia1
  • Negar Fani, PhD, ABPP · PRINCIPAL_INVESTIGATOR · Emory University

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Eligibility criteria

Inclusion

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

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.
  • Change in Hamilton Anxiety Rating Scale (HAM-A)Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention

    The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-rated assessment used to quantify the severity of anxiety symptoms. It consists of 14 items, each defined by a series of symptoms that measure both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each of the 14 items is scored on a scale of 0 (not present) to 4 (very severe). Total score ranges from 0 to 56. Higher scores indicate greater anxiety severity.

  • Change in State Trait Anxiety Inventory (STAI)Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention

    The State-Trait Anxiety Inventory (STAI) is a 40-item self-report scale used to measure the intensity of anxiety. Each item is rated on a 4-point Likert scale (e.g., 1 = "not at all" to 4 = "very much so" or 1 = "almost never" to 4 = "almost always"). Total Score ranges from 20-80 with higher scores indicate greater levels of anxiety.

  • Change in Difficulties in Emotion Regulation Scale (DERS) ScoreBaseline, 2-5 weeks post-intervention, 6 weeks post-intervention

    The DERS is a 36 item instrument that measures emotional dysregulation symptoms. Responses are given on a 5-point scale where 1 = almost never and 5 = almost always. The DERS scales include 1) nonacceptance of emotional responses, 2) difficulty engaging in goal-directed behavior, 3) difficulties with impulse control, 4) limited emotional awareness, 5) limited access to emotion regulation strategies, and 6) lack of emotional clarity. Total scores range from 36 to 180 and higher scores suggest greater problems with emotion regulation.

  • Change in PTSD Symptom Checklist (PCL-5) ScoreBaseline, 2-5 weeks post-intervention, 6 weeks post-intervention

    The PCL-5 is a 20-item self-report measure that assess the DSM-V symptoms of PTSD. Responses are given on a scale from 0 to 4 where 0 = not at all and 4 = extremely. Total scores range from 0 to 80 where higher scores indicate increased symptoms of PTSD.