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Temporal Interference Stimulation for Social Cognition

NCT06607432 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-23

No results posted yet for this study

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

Interventions

DEVICE

Transcranial Interference Stimulation (tIS)

Field strength dose of 0.30 - 0.40 V/m

OTHER

Sham tIS

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

Sponsors & Collaborators

Principal Investigators

  • Daniel C Javitt, M.D., Ph.D. · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2027-12-01
Completion
2028-02-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06607432 on ClinicalTrials.gov