Use of Alpha-frequency Deep Transcranial Interference Stimulation (tIS) to Understand and Modify Temporal Dynamics of Face Emotion Recognition and Social/Affective Function
Columbia University
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.
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 use of tIS in the US. tIS may be useful in the treatment of social cognitive impairments in schizophrenia and especially in the reversal of oscillatory dysfunction of the pulvinar nucleus of the thalamus. The overall project will investigate the safety and tolerability of tIS first in healthy volunteers and then in individuals with schizophrenia. This protocol is for stage 1a of the overall project…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
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/…
Interventions
- DeviceTranscranial Interference Stimulation (tIS)
Field strength dose of 0.30 - 0.40 V/m
- OtherSham tIS
Sham transcranial interferential stimulation. Sham comparator to be administered to all groups.
Location
- Columbia University Irving Medical Center/NewYork-Presbyterian Hospital (CUIMC/NYPH)New York, New York