Schizophrenia Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
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• 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.

Locations
United States
New York
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital (CUIMC/NYPH)
RECRUITING
New York
Contact Information
Primary
Daniel C Javitt, M.D., Ph.D.
dcj2113@cumc.columbia.edu
1 6467745404
Backup
Pejman Sehatpour, Ph.D.
ps2723@cumc.columbia.edu
1 6467745236
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2028-02-29
Participants
Target number of participants: 30
Treatments
Active_comparator: Active tIS 0.30 V/m and Sham
Group 1 with 10 participants to receive a dose of 0.30 V/m and sham. The order of the intervention will be randomized.
Active_comparator: Active tIS 0.35 V/m and Sham
Group 2 with 10 participants to receive a dose of 0.35 V/m and sham. The order of the intervention will be randomized.
Active_comparator: Active tIS 0.40 V/m and Sham
Group 3 with 10 participants to receive a dose of 0.40 V/m and sham. The order of the intervention will be randomized.
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov