Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
All Genders
Healthy Volunteers
NCT06607432

Temporal Interference Stimulation for Social Cognition

Led by Columbia University · Updated on 2026-04-23

10

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Temporal Interference Stimulation for Social Cognition

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female
  • Age 18-55 years
  • Intelligence quotient (IQ) above 70 on the Wechsler Adult Intelligence Scale (WAIS)
  • Able and willing to provide informed consent
  • No standing use of medications for psychiatric disorders or certain nervous system drugs within 90 days
  • Intermittent use of sedative/hypnotics allowed but not within 48 hours before tIS
  • Healthy based on medical history and physical exam within 90 days of enrollment
Not Eligible

You will not qualify if you...

  • Any illness or condition that may interfere with study completion or affect data quality
  • Contraindications to MRI such as metal implants, claustrophobia, or pregnancy
  • Moderate to high suicide risk based on Columbia-Suicide Severity Rating Scale responses
  • Significant medical illnesses including abnormal blood pressure, cardiac illness, or abnormal ECG
  • Women of childbearing potential who are pregnant, not using effective contraception, or planning pregnancy during study

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

New York, New York, United States, 10032

Actively Recruiting

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Research Team

D

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

CONTACT

P

Pejman Sehatpour, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

3

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