RecruitingNot ApplicableNCT06607432

Temporal Interference Stimulation for Social Cognition

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

Sponsor

Columbia University

Enrollment

10 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy (Controls)

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

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria6

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 Criteria8

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).