Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-03-03
2028-02-29
Brief Summary
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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.
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Detailed Description
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The stage 1a involves 30 healthy individuals and employs advanced techniques such as simultaneous electroencephalogram (EEG)/tIS, functional magnetic resonance imaging (fMRI), and magnetic resonance spectroscopy (MRS) to investigate the spatio-temporal dynamics of face emotion processing. These methods help us pinpoint specific brain regions like the pulvinar nucleus of the thalamus (PuN) and assess the safety and potential therapeutic benefits of tIS. Participants initially undergo an MRI session to localize their individual pulvinar nucleus of the thalamus (PuN). This step allows the investigators to model transcranial current flow accurately and precisely target the PuN using tIS. Subsequently, participants engage in simultaneous EEG recordings and tIS, which falls under the umbrella of transcranial electrical stimulation (tES). The timing of these sessions, whether single or repeated, depends on the study stage. The investigators also assess brain metabolism effects through MRS before and after tIS stimulation. Participants will go through several steps: 1) Interviews to determine eligibility 2) Behavioral tests of their ability to detect and interpret visual stimuli 3) "Brain wave" recordings or electroencephalogram 4) A non-invasive brain stimulation technique termed transcranial interference stimulation 5) Magnetic resonance imaging (MRI). Participants will also have an electrocardiogram and medical examination to evaluate their general health.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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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.
Transcranial Interference Stimulation (tIS)
Field strength dose of 0.30 - 0.40 V/m
Sham tIS
Sham transcranial interferential stimulation. Sham comparator to be administered to all groups.
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.
Transcranial Interference Stimulation (tIS)
Field strength dose of 0.30 - 0.40 V/m
Sham tIS
Sham transcranial interferential stimulation. Sham comparator to be administered to all groups.
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.
Transcranial Interference Stimulation (tIS)
Field strength dose of 0.30 - 0.40 V/m
Sham tIS
Sham transcranial interferential stimulation. Sham comparator to be administered to all groups.
Interventions
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Transcranial Interference Stimulation (tIS)
Field strength dose of 0.30 - 0.40 V/m
Sham tIS
Sham transcranial interferential stimulation. Sham comparator to be administered to all groups.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
55 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Columbia University
OTHER
Responsible Party
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Daniel C. Javitt, MD
Professor of Psychiatry
Principal Investigators
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Daniel C Javitt, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University Irving Medical Center/NewYork-Presbyterian Hospital (CUIMC/NYPH)
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Violante IR, Alania K, Cassara AM, Neufeld E, Acerbo E, Carron R, Williamson A, Kurtin DL, Rhodes E, Hampshire A, Kuster N, Boyden ES, Pascual-Leone A, Grossman N. Non-invasive temporal interference electrical stimulation of the human hippocampus. Nat Neurosci. 2023 Nov;26(11):1994-2004. doi: 10.1038/s41593-023-01456-8. Epub 2023 Oct 19.
Grossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N, Tsai LH, Pascual-Leone A, Boyden ES. Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields. Cell. 2017 Jun 1;169(6):1029-1041.e16. doi: 10.1016/j.cell.2017.05.024.
Other Identifiers
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AAAV1631 (Stage 1a)
Identifier Type: -
Identifier Source: org_study_id
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