NCT06607432 Temporal Interference Stimulation for Social Cognition
| NCT ID | NCT06607432 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Healthy Controls |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-03-03 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Daniel C Javitt, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT06607432 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Healthy Controls. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06607432 currently recruiting?
Yes, NCT06607432 is actively recruiting participants. Contact the research team at dcj2113@cumc.columbia.edu for enrollment information.
Where is the NCT06607432 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06607432 clinical trial?
NCT06607432 is sponsored by Columbia University. The principal investigator is Daniel C Javitt, M.D., Ph.D. at Columbia University. The trial plans to enroll 10 participants.