Recruiting

Temporal Interference

Sponsor:

Columbia University

Code:

NCT06607432

Conditions

Healthy Controls

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Transcranial Interference Stimulation (tIS)

Sham tIS

Study Details

Brief 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. 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.

Conditions

Healthy Controls

Study ID

NCT06607432

Start date

Mar 3, 2025

Status verified date

Apr, 2026

Completion date

Feb 29, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

active comparator: Active tIS 0.30 V/m and Sham

Group 1 with 10 participants to receive a dose of 0.30 V/m and sham. The order of the intervention will be randomized.

active comparator: Active tIS 0.35 V/m and Sham

Group 2 with 10 participants to receive a dose of 0.35 V/m and sham. The order of the intervention will be randomized.

active comparator: Active tIS 0.40 V/m and Sham

Group 3 with 10 participants to receive a dose of 0.40 V/m and sham. The order of the intervention will be randomized.

Interventions

Transcranial Interference Stimulation (tIS)

Field strength dose of 0.30 - 0.40 V/m

Sham tIS

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

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 ]
  • Amplitude of 10-Hz visual Steady-State Response (ssVEP) [ Time Frame: Twice during each phase (day 8, day 15): 1x during active stimulation, 1x during sham stimulation in randomized order across participants ]

Central Contacts and Locations

Central contacts

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

1 6467745404dcj2113@cumc.columbia.edu

Pejman Sehatpour, Ph.D.

1 6467745236ps2723@cumc.columbia.edu

Locations

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

Recruiting

New York, New York, United States, 10032

Contacts

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

1 6467745404dcj2113@cumc.columbia.edu

Pejman Sehatpour, Ph.D.

1 6467745236ps2723@cumc.columbia.edu

Principal Investigator:

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

More Information

Sponsor

Columbia University

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Transcranial Interference Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-04-23.