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Healthy ControlsTISSCNCT06607432

Temporal Interference Stimulation for Social Cognition

A study testing Transcranial Interference Stimulation (tIS) in people with Healthy Controls, run by Columbia University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The long-term goal of this project is to evaluate whether a procedure termed transcranial interference stimulation (tIS) may be useful in the future in the treatment of severe neuropsychiatric disorders such as schizophrenia. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Controls
What is being tested?
Transcranial Interference Stimulation (tIS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
1 siteUnited States
Study dates
3 Mar 2025to 29 Feb 2028
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female
  • Age 18-55 years
  • Wechsler Adult Intelligence Scale (WAIS) intelligence quotient (IQ) >70
  • Competent and willing to sign informed consent.
  • Shall not have been prescribed any standing medications for treatment of a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Axis I psychiatric disorders within 90 days of the study and shall not have been prescribed standing opioid analgesic, anticonvulsant, antidementia, antidepressant, antimigraine, antipsychotic, anxiolytic, bipolar agents, central nervous system agents, or sedative/hypnotics within 90 days of the study even if for a non-psychiatric indication. Intermittent use of sedative/hypnotic medications is permitted, but these agents shall not be used within 48 hours of the tIS administration.
  • Healthy relative to age-dependent expectation as determined by medical history and physical examination within 90 days of enrollment.

Who cannot join

  • Has a history of an illness, disease, condition injury, or disability which, in the opinion of the principal investigator (PI), may interfere with the completion of all study requirements per protocol, impact the quality of the data, or the validity of the study results.
  • Contraindication to MRI (e.g. metal implants, claustrophobia, pregnancy)
  • On the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version-Recent, answers YES to Question 3 and NO to Question 6 (Moderate Risk) or answers YES to Question 4, 5, or 6 (High Risk).
  • Presence or positive history of significant medical illnesses, including high blood pressure(defined as systolic blood pressure (SBP) >140 or diastolic blood pressure (DBP) >90, low blood pressure (SBP <100, DBP <60), orthostatic blood pressure as baseline (change in mean arterial pressure [1/3 systolic + 2/3 diastolic] of >20%), cardiac illness, or clinical significant abnormal electrocardiogram (EKG), as determined by the site physician
  • Women of childbearing potential who, at enrollment or during the study:
  • have a positive urine pregnancy test or a self-reported pregnancy;
  • are heterosexually active without usage of a medically acceptable, highly effective contraceptive method* ( 1% pregnancy rate); or
  • are planning to become pregnant during the course of this study, as determined by the PI, are excluded from study participation. Examples include tubal ligation, vasectomized partner, intrauterine device (IUD) or intrauterine system (IUS), and longacting reversible contraceptives (LARC).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel C Javitt, M.D., Ph.D. contact

1 6467745404

dcj2113@cumc.columbia.edu

Pejman Sehatpour, Ph.D. contact

1 6467745236

ps2723@cumc.columbia.edu

United States1 site, 1 recruiting

  • Columbia University Irving Medical Center/NewYork-Presbyterian Hospital (CUIMC/NYPH)

    New York, New York, 10032

    Daniel C Javitt, M.D., Ph.D., 1 6467745404, dcj2113@cumc.columbia.edu

    Pejman Sehatpour, Ph.D., 1 6467745236, ps2723@cumc.columbia.edu

    Recruiting

Other trials in United States

About this study

Official title: Use of Alpha-frequency Deep Transcranial Interference Stimulation (tIS) to Understand and Modify Temporal Dynamics of Face Emotion Recognition and Social/Affective Function

The long-term goal of this project is to evaluate whether a procedure termed transcranial interference stimulation (tIS) may be useful in the future in the treatment of severe neuropsychiatric disorders such as schizophrenia. The purpose of this stage of the project is to evaluate the safety and tolerability of tIS administration in healthy volunteers.

This study involves 10 healthy participants without known psychiatric illness X 3 successive doses. Participants may participate in 1-3 doses, yielding a total sample size of 10-30 individuals across doses. The dose of tIS will be escalated progressively across doses. Functional magnetic resonance imaging (fMRI), magnetic resonance spectroscopy (MRS) and side effect checklists will be used to assess tIS safety/tolerability at each dose. In addition, electroencephalogram (EEG) will be collected simultaneously with tIS and used to assess target engagement. Face emotion recognition (FER) data will also be collected, but will be used for feasibility assessment only.

If successful, these studies will form the basis for future studies in schizophrenia.

Read the detailed description

Transcranial interference stimulation (tIS) has been used outside of the United States (US) but not previously under Food and Drug Administration (FDA) regulation. This represents the first in human use of tIS in the US. tIS may be useful in the treatment of social cognitive impairments in schizophrenia and especially in the reversal of oscillatory dysfunction of the pulvinar nucleus of the thalamus. The overall project will investigate the safety and tolerability of tIS first in healthy volunteers and then in individuals with schizophrenia. This protocol is for stage 1a of the overall project only. In this stage, safety and tolerability will be assessed along with initial evaluation of target engagement. This stage uses a single ascending dose design with 10 participants per dose at each of three doses.

The stage 1a involves 30 healthy individuals and employs advanced techniques such as simultaneous electroencephalogram (EEG)/tIS, functional magnetic resonance imaging (fMRI), and magnetic resonance spectroscopy (MRS) to investigate the spatio-temporal dynamics of face emotion processing. These methods help us pinpoint specific brain regions like the pulvinar nucleus of the thalamus (PuN) and assess the safety and potential therapeutic benefits of tIS. Participants initially undergo an MRI session to localize their individual pulvinar nucleus of the thalamus (PuN). This step allows the investigators to model transcranial current flow accurately and precisely target the PuN using tIS. Subsequently, participants engage in simultaneous EEG recordings and tIS, which falls under the umbrella of transcranial electrical stimulation (tES). The timing of these sessions, whether single or repeated, depends on the study stage. The investigators also assess brain metabolism effects through MRS before and after tIS stimulation. Participants will go through several steps: 1) Interviews to determine eligibility 2) Behavioral tests of their ability to detect and interpret visual stimuli 3) "Brain wave" recordings or electroencephalogram 4) A non-invasive brain stimulation technique termed transcranial interference stimulation 5) Magnetic resonance imaging (MRI). Participants will also have an electrocardiogram and medical examination to evaluate their general health.

Being tested
Transcranial Interference Stimulation (tIS), Sham tIS
Keywords
Transcranial Interference Stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Interference Stimulation (tIS)Device

    Also called Interference frequency stimulation (IFS), Transcranial Interference (TI)

    Field strength dose of 0.30 - 0.40 V/m

  • Sham tISOther

    Sham transcranial interferential stimulation. Sham comparator to be administered to all groups.

Study groups in NCT06607432
Study groupRoleWhat they receive
Active tIS 0.30 V/m and ShamActive comparatorGroup 1 with 10 participants to receive a dose of 0.30 V/m and sham. The order of the intervention will be randomized.
Receives: Device: Transcranial Interference Stimulation (tIS); Other: Sham tIS
Active tIS 0.35 V/m and ShamActive comparatorGroup 2 with 10 participants to receive a dose of 0.35 V/m and sham. The order of the intervention will be randomized.
Receives: Device: Transcranial Interference Stimulation (tIS); Other: Sham tIS
Active tIS 0.40 V/m and ShamActive comparatorGroup 3 with 10 participants to receive a dose of 0.40 V/m and sham. The order of the intervention will be randomized.
Receives: Device: Transcranial Interference Stimulation (tIS); Other: Sham tIS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulvinar nucleus (PuN) activation levels

    Pulvinar nucleus (PuN) activation levels as determined by functional magnetic resonance imaging (fMRI, safety)

    These analyses assess the degree to which presentation of a stimulus designed to activate the pulvinar nucleus leads to an increase in local activation as reflected in the fMRI response. Units will be % increase in signal strength during stimulation vs. baseline.

    Measured: Once at baseline (day 1) and twice during each phase (day 8, day 15): 1x following active stimulation, 1x following sham stimulation in randomized order across participants

  2. Amplitude of 10-Hz visual Steady-State Response (ssVEP)

    (Target engagement) This measure is obtained simultaneously with tIS and reflects the response of visual cortex to repetitive stimulation. Response is measured in microvolt-squared (uV2).

    Measured: Twice during each phase (day 8, day 15): 1x during active stimulation, 1x during sham stimulation in randomized order across participants

Secondary outcomes (5)

  1. Brunoni safety scale

    The Brunoni scale is a self-report scale for potential side effects following tIS, including headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, trouble concentrating, acute mood change and "other"; Scores range from 1 (no discomfort) to 5 (severe discomfort). HIgher scores indicate greater severity.

    Measured: Following each tIS session (day 8, 15)

  2. Wong-Baker safety scale

    The Wong-Baker uses emotion faces to allow individuals to indicate the level of discomfort associated with the procedure. Scores range from 1 (no discomfort) to 5 (severe discomfort). Higher scores indicate greater discomfort.

    Measured: Following each tIS session (day 8, 15)

  3. Pulvinar nucleus (PuN) tissue levels of N-acetyl aspartate (NAA)

    PuN tissue level of N-acetyl-aspartate (NAA)as determined by MRS (safety)

    NAA is a potential measure of oxidative stress. NAA levels will be measured as the amplitude of the NAA peak of the MRS spectrum.

    Measured: Once at baseline (day 1) and twice during each phase (day 8, 15): 1x following active stimulation, 1x following sham stimulation in randomized order across participants

  4. Pulvinar nucleus (PuN) tissue levels of glutathione (GSH)

    PuN tissue levels of glutathione (GSH), as determined by MRS (safety)

    GSH is a potential measure of oxidative stress. It will be defined based on the amplitude of the GSH peak in the MRS spectrum.

    Measured: Once at baseline (day 1) and twice during each phase (day 8, 15): 1x following active stimulation, 1x following sham stimulation in randomized order across participants

  5. Columbia Suicide Severity Rating Scale (C-SSRS)

    The Columbia Suicide Severity Rating scale captures information on any thoughts you may be having regarding self-harm. The scale is scored from 0 (No thoughts) to 5 (Active suicidal ideation with plan and intent). Higher scores indicate more severe risk of suicidal behavior.

    Measured: Days 1, 8, 15, 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2024
  2. Study start3 Mar 2025
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion29 Feb 2028 (estimated)

Resources

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
Device feasibility
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06607432
Sponsor's protocol ID
AAAV1631 (Stage 1a)
Other IDs
1U01MH135436
Acronym
TISSC
Status last verified
Apr 2026
First submitted
16 Sep 2024
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: De-identified data will be shared via the NIMH Data Archives (NDA). Participants will be coded using global unique identifiers (GUIDs).

Publications

  • Violante IR, Alania K, Cassara AM, Neufeld E, Acerbo E, Carron R, Williamson A, Kurtin DL, Rhodes E, Hampshire A, Kuster N, Boyden ES, Pascual-Leone A, Grossman N. Non-invasive temporal interference electrical stimulation of the human hippocampus. Nat Neurosci. 2023 Nov;26(11):1994-2004. doi: 10.1038/s41593-023-01456-8. Epub 2023 Oct 19.

    PubMed 37857775

  • Grossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N, Tsai LH, Pascual-Leone A, Boyden ES. Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields. Cell. 2017 Jun 1;169(6):1029-1041.e16. doi: 10.1016/j.cell.2017.05.024.

    PubMed 28575667

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Interference Stimulation (tIS) in people with Healthy Controls, run by Columbia 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 6 inclusion and 8 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 23 Apr 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. 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 Daniel C Javitt, M.D., Ph.D. (1 6467745404, dcj2113@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulvinar nucleus (PuN) activation levels (time frame: Once at baseline (day 1) and twice during each phase (day 8, day 15): 1x following active stimulation, 1x following sham stimulation in randomized order across participants). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06607432, which also lists 2 linked publications.

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 23 Apr 2026.

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