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

NCT07558759 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2025P012849
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

Temporal Interference

Outcome Measures

Primary Outcomes (4)

• Change in Hamilton Anxiety Rating Scale (HAM-A)

  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.

  Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention

• Change in State Trait Anxiety Inventory (STAI)

  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.

  Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention

• Change in Difficulties in Emotion Regulation Scale (DERS) Score

  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.

  Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention

• Change in PTSD Symptom Checklist (PCL-5) Score

  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.

  Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention

Secondary Outcomes (22)

• Change in Multiscale Dissociation Inventory (MDI) Score

  Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention

• Change in Kentucky Mindfulness Scale (KIMS) Score

  Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention

• Change in Multidimensional Assessment of Interoceptive Awareness (MAIA) Score

  Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention

• Change in Attentional Control Scale (ACS) Score

  Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention

• Change in Change in Life Events Checklist Score

  Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention

Study Arms (2)

Temporal Interference (TI) stimulation

EXPERIMENTAL

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.

Device: Electrical stimulation device

Sham TI stimulation

SHAM COMPARATOR

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.

Device: Electrical stimulation device

Interventions

Electrical stimulation device 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.

Temporal Interference (TI) stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Negar Fani, PhD, ABPP

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Jones

CONTACT

404-712-0354; gtpaffectneurolab@emory.edu

Alisha Sylvester

CONTACT

alisha.marie.sylvester@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)