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Recruiting NCT06607432

Temporal Interference Stimulation for Social Cognition

Trial Parameters

Condition Healthy Controls
Sponsor Columbia University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 55 Years
Start Date 2025-03-03
Completion 2027-12-01
Interventions
Transcranial Interference Stimulation (tIS)Sham tIS

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 30 healthy participants without known psychiatric illness, who will participate in groups of 10. 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 i

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