NCT07558759 · Emory University
Temporal Interference in Psychiatry (TIP): Neuromodulation Using Temporal Interference
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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.
DEVICE
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 measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Atlanta, Georgia
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations