AnxietyNCT07558759
Temporal Interference in Psychiatry (TIP): Neuromodulation Using Temporal Interference
A study testing Electrical stimulation device in people with Anxiety and PTSD, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Electrical stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2026to Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alisha Sylvester contact
United States1 site, 1 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Rachel Jones, rachel.ivy.jones@emory.edu
Negar Fani, PhD, ABPP
About this study
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.
Read the detailed description
In this study, the investigators aim to understand the neural, behavioral and clinical effects of temporal interference (TI), a type of neuromodulation method.
This method involves placement of electrodes on the scalp that deliver a low voltage electrical field at different alternating high frequency fields to modulate the function of brain areas. The study will use magnetic resonance imaging (MRI) and electroencephalography (EEG) to assess the effects of TI on brain response. The study team will also assess mood (measured via clinical assessments and self-report ratings), physiology (measured via electrocardiography, galvanic skin response, respiration) behavior and cognition (performance on various cognitive and other behavioral tasks). To do so, the team will stimulate and inhibit brain regions that are relevant to anxiety, mood, and cognition, areas of the brain hypothesized to be selectively engaged with cognition of a given category, or cost-benefit decision-making (depending on the behavioral tasks used). In an optional study, the investigators will use Ecological Momentary Assessment (EMA) to examine a behavioral translation of the neural mechanisms tested using TI by inquiring about individuals' mood and behavior in daily life. This study will recruit healthy controls and patients with psychiatric symptoms to investigate these effects. Psychiatric symptoms will be assessed based on self-report questionnaires. Such an aim will not only provide a deeper understanding of how TI may be used to target different processes of relevance to psychiatric disorders but also the duration of effects.
Temporal Interference (TI) stimulation is an emerging, non-invasive neuromodulation method which allows focal electrical stimulation of deep brain structures without affecting overlying cortical regions. Preclinical studies and early human applications suggest that TI may modulate emotion-related brain activity with the potential to improve symptoms in psychiatric conditions. This study aims to evaluate the preliminary efficacy of TI stimulation in healthy populations and in individuals with anxiety and stress-related conditions (Aim 1) as well as feasibility, safety, and effects of different frequencies and doses of TI (Aim 2). Outcomes will be evaluated using a battery of neural (MRI, EEG), physiological, behavioral (affective tasks), cognitive, and mood assessments. In addition, the study team aim to explore the longitudinal mental-health outcomes of TI using daily assessments (Aim 3). Participants will be invited to electronically respond to questionnaires and compose a diary over a 4-week period, and these data will be compared with neural recordings. This component will assess the validity and feasibility of remote tracking of anxiety symptoms in real-world settings - and perhaps detect nuanced improvements of symptoms from intermittent TI sessions, not as readily seen in weekly in person clinical assessments.
- Being tested
- Electrical stimulation device
- Keywords
- Temporal Interference
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulation deviceDevice
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 deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Electrical stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Secondary outcomes (22)
Change in Multiscale Dissociation Inventory (MDI) Score
The MDI is a 30-item self-report test of dissociative symptomology and measures six different types of dissociative responses: disengagement, depersonalization, derealization, emotional constriction/numbing, memory disturbance, and identity dissociation. Items are scored on a 5-point scale where 1 = never and 5 = very often. Total dissociation scores range from 30 to 150 where higher scores indicate greater symptoms of dissociation.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Kentucky Mindfulness Scale (KIMS) Score
The Kentucky Mindfulness Scale is a 39-item scale that assesses skills related to what one does while practicing mindfulness. Items are rated on a 5 point Likert scale ranging from 1 (never or very rarely true) to 5 (almost always or always true). Items reflect either direct descriptions of the mindfulness skills, or they describe the absence of that skill and are reverse scored. Total scores range from 39 to 195 and higher scores reflect more mindfulness.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Multidimensional Assessment of Interoceptive Awareness (MAIA) Score
This is a clinical measure that assesses various aspects of interoception, including ability to attend to body sensations, regulate distress by attending to body sensations, and experiencing body sensations as safe and trustworthy. The instrument includes 32 items and which are scored from 0 to 5, where 0 = never and 5 = always. Total scores range from 0 to 160 and higher scores indicate greater awareness of body sensations.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Attentional Control Scale (ACS) Score
This is a 20-item self-report measure that assesses attentional control a 4-point Likert scale, where 1 = almost never and 4 = always. Total scores range from 20 to 80 and higher scores indicate greater difficulty with attentional control.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Change in Life Events Checklist Score
The Life Events Checklist includes 21 items asking respondents if they have been exposed to stressful events in the last 3 to 4 weeks. Participants are also able to list stressful events or experiences that are not specifically listed. Responses are coded as 5 = happened to me, 4 = witnessed it, 3 = learned about it, 2 = part of my job, 1 = not sure, and 0 = does not apply. A total score or composite score is not calculated for the Life Events Checklist, rather this instrument is used to identify if the respondent has experienced traumatic situations.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Sense of Agency Rating Scale (SOARS) Score
The SOARS is a 10-item self-report measure that assess the sense of control one has over their body. Responses are given on a 7-point Likert scale where 1 = strongly disagree and 7 = strongly agree. Total scores range from 10 to 70 where lower scores indicate greater sense of agency.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Scale of Body Connection (SBC) Body Awareness Score
The Scale of Body Connection instrument has 20 items assessing the dimensions of Body Awareness and Bodily Dissociation. Items are scored on a 5-point scale where 0 = not at all and 4 = all of the time. The body awareness dimension has 12 items and the body awareness score is the average of responses to these items. Higher scores indicate greater bodily awareness.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Alcohol Lifetime Score
The KMSK assesses lifetime alcohol use with up to 7 items. Three of the items are scored quantitatively on varying scales. Total scores range from 0 to 13 where higher scores indicate greater lifetime use of alcohol.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-D) Score
The PROMIS-D instrument assesses depression with 9 items asking respondents if they have experienced certain symptoms of depression in the past 7 days. Responses are given on a 5-point scale. Total scores are transformed to a t-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate increased depressive symptoms compared to the reference population.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
PHQ-9
The Patient Health Questionnaire (PHQ-9) is a 9-item self-report tool used to screen, diagnose, and monitor the severity of depression. Each of the 9 items is scored on a scale of 0 (not at all) to 3 (nearly every day). The individual item scores are summed to provide a total score ranging from 0 to 27. Higher scores indicate greater depression severity.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Positive and Negative Affect Schedule - Expanded Form (PANAS-X) Positive Affect (PA)
The Positive and Negative Affect Schedule - Expanded Form (PANAS-X) Positive Affect (PA) Scale is a 10-item self-report subscale used to measure the extent to which a person feels enthusiastic, active, and alert. Each of the 10 items is rated on a 5-point Likert scale, ranging from 1 (very slightly or not at all) to 5 (extremely). The individual item scores are summed to provide a total score ranging from 10 to 50. Higher scores indicate higher levels of energy, pleasurable engagement, and concentration.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Positive and Negative Affect Schedule - Expanded Form (PANAS X) Negative
The Positive and Negative Affect Schedule - Expanded Form (PANAS-X) Negative Affect (NA) Scale is a 10-item self-report subscale used to measure a general dimension of subjective distress and unpleasurable engagement.
Each of the 10 items is rated on a 5-point Likert scale, ranging from 1 (very slightly or not at all) to 5 (extremely).
The individual item scores are summed to provide a total score ranging from 10 to 50. Higher scores indicate greater levels of distress, fear, and dissatisfaction.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item, self-administered patient questionnaire used to measure the severity of anxiety symptoms over the past two weeks. Each item identifies a specific symptom (e.g., feeling nervous, anxious, or on edge). Each of the 7 items is rated on a 4-point Likert scale (0 = Not at all,1 = Several days, 2 = More than half the days, 3 = Nearly every day). The individual item scores are summed to provide a total score ranging from 0 to 21. Higher scores indicate greater anxiety severity.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Childhood Trauma Questionnaire (CTQ) Score
The Childhood Trauma Questionnaire (CTO) has 28 items asking respondents if they experienced situations of trauma as a child or teenager. Responses are given on a 5-point scale (1= never true and 5 = always true). There are subscales for sexual abuse, physical abuse, emotional abuse, emotional neglect, and physical neglect, and a total trauma score is calculated. Total scores range from 28 to 140 where higher scores indicate more severe trauma.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Motivation and Pleasure Scale Self-Report (MAP-SR) Score
The MAP-SR is an 18-item questionnaire assessing the degree of pleasure experienced with social, work or recreational, and family situations and the amount of motivation to engage in activities. Responses are given on a 5-point scale where 0 = no pleasure or no motivation and 4 = extreme pleasure or motivation. Total scores range from 0 to 72. Scoring for certain items is reversed so that higher scores indicate increased pleasure and motivation.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Ruminative Responses Scale Score
The Ruminative Responses Scale is a 22-item instrument assessing different things that people do when they feel depressed. Responses are given on a 4-point scale where 1 = almost never and 4 = almost always. Total scores range from 22 to 88 and higher scores indicate greater rumination on depressive symptoms, potentially prolonging depressive episodes.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Everyday Discrimination Scale (EDS) Score
The original Everyday Discrimination Scale includes 9 items asking respondents how often they experience certain situations of discrimination. Responses are given on a 6-point scale where 1 = never and 6 = almost everyday. Total scores range from 9 to 54 where higher scores indicate experiencing increased discrimination.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Experiences of Discrimination (EOD) Scale Score
The Experiences of Discrimination Questionnaire is an 11-item instrument assessing experiences of discrimination because of race, ethnicity, or color. Respondents indicate if they have or have not experienced 9 situations of discrimination (no = 0 and yes = 1), and then there are two questions about how often respondents feel that discrimination occurs that are score as 1 = never and 4 = often. Total scores range from 2 to 17 where higher scores indicate greater experiences of discrimination.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Alcohol Use Disorders Identification Test (AUDIT) score
The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item self-report or clinician-administered questionnaire designed to identify hazardous and harmful patterns of alcohol consumption. It covers three domains: alcohol consumption, dependence symptoms and harmful alcohol use.
Each of the 10 items is scored on a scale of 0 to 4. The individual item scores are summed to provide a total score ranging from 0 to 40. A higher score indicates a greater likelihood of hazardous and harmful drinking or alcohol dependence.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Drug Abuse Screening Test (DAST-10) score
The Drug Abuse Screening Test (DAST-10) is a 10-item self-report scale designed to provide a brief instrument for clinical screening and treatment evaluation of drug use (excluding alcohol and tobacco) during the past 12 months. Each item is answered with a binary "Yes" (1) or "No" (0). The individual item scores are summed to provide a total score ranging from 0 to 10. Higher scores indicate a greater degree of problem severity related to drug use.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Epworth Sleepiness Scale Score
The Epworth Sleepiness Scale is an 8-item instrument assessing level of daytime sleepiness. Responses are given on a 4-point scale where 0 = would never doze and 3 = high chance of dozing. Total scores range from 0 to 24, where scores between 0 and 10 are considered normal and scores above 16 are indicative of high levels of excessive daytime sleepiness.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Penn Computerized Neuropsychological Battery (Penn CNP) Performance
This is a computerized neuropsychological assessment that is designed to examine different domains of cognitive functioning. The executive functioning and memory components of this battery (which include measures of sustained attention and working memory) will be administered, which take approximately 30 minutes to complete.
Measured: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start7 Apr 2026
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Negar Fani, Emory University
- Investigators
- Negar Fani, PhD, ABPP, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558759
- Sponsor's protocol ID
- 2025P012849
- Status last verified
- Jul 2026
- First submitted
- 23 Apr 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Interference in Psychiatry (TIP): Neuromodulation Using Temporal Interference
- ClinicalTrials.gov ID
- NCT07558759
- Acronym / sponsor ID
- 2025P012849
- Keywords
- Temporal Interference
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, the investigators aim to understand the neural, behavioral and clinical effects of temporal interference (TI), a type of neuromodulation method.
This method involves placement of electrodes on the scalp that deliver a low voltage electrical field at different alternating high frequency fields to modulate the function of brain areas. The study will use magnetic resonance imaging (MRI) and electroencephalography (EEG) to assess the effects of TI on brain response. The study team will also assess mood (measured via clinical assessments and self-report ratings), physiology (measured via electrocardiography, galvanic skin response, respiration) behavior and cognition (performance on various cognitive and other behavioral tasks). To do so, the team will stimulate and inhibit brain regions that are relevant to anxiety, mood, and cognition, areas of the brain hypothesized to be selectively engaged with cognition of a given category, or cost-benefit decision-making (depending on the behavioral tasks used). In an optional study, the investigators will use Ecological Momentary Assessment (EMA) to examine a behavioral translation of the neural mechanisms tested using TI by inquiring about individuals' mood and behavior in daily life. This study will recruit healthy controls and patients with psychiatric symptoms to investigate these effects. Psychiatric symptoms will be assessed based on self-report questionnaires. Such an aim will not only provide a deeper understanding of how TI may be used to target different processes of relevance to psychiatric disorders but also the duration of effects.
Temporal Interference (TI) stimulation is an emerging, non-invasive neuromodulation method which allows focal electrical stimulation of deep brain structures without affecting overlying cortical regions. Preclinical studies and early human applications suggest that TI may modulate emotion-related brain activity with the potential to improve symptoms in psychiatric conditions. This study aims to evaluate the preliminary efficacy of TI stimulation in healthy populations and in individuals with anxiety and stress-related conditions (Aim 1) as well as feasibility, safety, and effects of different frequencies and doses of TI (Aim 2). Outcomes will be evaluated using a battery of neural (MRI, EEG), physiological, behavioral (affective tasks), cognitive, and mood assessments. In addition, the study team aim to explore the longitudinal mental-health outcomes of TI using daily assessments (Aim 3). Participants will be invited to electronically respond to questionnaires and compose a diary over a 4-week period, and these data will be compared with neural recordings. This component will assess the validity and feasibility of remote tracking of anxiety symptoms in real-world settings - and perhaps detect nuanced improvements of symptoms from intermittent TI sessions, not as readily seen in weekly in person clinical assessments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temporal Interference (TI) stimulation | Experimental | Device: Electrical stimulation deviceParticipants 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 TI stimulation | Sham comparator | Device: Electrical stimulation deviceParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical stimulation deviceTemporal 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. | Device | Temporal Interference (TI) stimulation |
| Electrical stimulation deviceElectrodes 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. | Device | Sham TI stimulation |
Primary outcome
Change in Hamilton Anxiety Rating Scale (HAM-A)
Time frame: 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)
Time frame: 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) Score
Time frame: Baseline, 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) Score
Time frame: Baseline, 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.
22 secondary outcomes
Change in Multiscale Dissociation Inventory (MDI) Score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Kentucky Mindfulness Scale (KIMS) Score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Multidimensional Assessment of Interoceptive Awareness (MAIA) Score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Attentional Control Scale (ACS) Score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Change in Life Events Checklist Score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Sense of Agency Rating Scale (SOARS) Score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Scale of Body Connection (SBC) Body Awareness Score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Alcohol Lifetime Score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-D) Score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
PHQ-9
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Positive and Negative Affect Schedule - Expanded Form (PANAS-X) Positive Affect (PA)
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Positive and Negative Affect Schedule - Expanded Form (PANAS X) Negative
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Childhood Trauma Questionnaire (CTQ) Score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Motivation and Pleasure Scale Self-Report (MAP-SR) Score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Ruminative Responses Scale Score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Everyday Discrimination Scale (EDS) Score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Experiences of Discrimination (EOD) Scale Score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Alcohol Use Disorders Identification Test (AUDIT) score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Drug Abuse Screening Test (DAST-10) score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Epworth Sleepiness Scale Score
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Change in Penn Computerized Neuropsychological Battery (Penn CNP) Performance
Time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alisha Sylvester contact
Negar Fani, PhD, ABPP principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation device in people with Anxiety and PTSD, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Jones (404-712-0354, gtpaffectneurolab@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Anxiety Rating Scale (HAM-A) (time frame: Baseline, 2-5 weeks post-intervention, 6 weeks post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026; AzTrials last refreshed its copy on 5 Nov 2026.