Status:
RECRUITING
Temporal Interference Stimulation for Social Cognition
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Healthy Controls
Eligibility:
All Genders
18-55 years
Phase:
NA
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 disorde...
Detailed Description
Transcranial interference stimulation (tIS) has been used outside of the United States (US) but not previously under Food and Drug Administration (FDA) regulation. This represents the first in human u...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 29 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06607432
Start Date
March 3 2025
End Date
February 29 2028
Last Update
August 20 2025
Active Locations (1)
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1
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital (CUIMC/NYPH)
New York, New York, United States, 10032