Temporal Interference Stimulation for Social Cognition

NCT06607432 | Recruiting DMC FDA Device

• 2 other identifiers: AAAV1631 (Stage 1a)1U01MH135436
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy Controls

Keywords

Transcranial Interference Stimulation

Outcome Measures

Primary Outcomes (2)

• Pulvinar nucleus (PuN) activation levels

  Pulvinar nucleus (PuN) activation levels as determined by functional magnetic resonance imaging (fMRI, safety) These analyses assess the degree to which presentation of a stimulus designed to activate the pulvinar nucleus leads to an increase in local activation as reflected in the fMRI response. Units will be % increase in signal strength during stimulation vs. baseline.

  Once at baseline (day 1) and twice during each phase (day 8, day 15): 1x following active stimulation, 1x following sham stimulation in randomized order across participants

• Amplitude of 10-Hz visual Steady-State Response (ssVEP)

  (Target engagement) This measure is obtained simultaneously with tIS and reflects the response of visual cortex to repetitive stimulation. Response is measured in microvolt-squared (uV2).

  Twice during each phase (day 8, day 15): 1x during active stimulation, 1x during sham stimulation in randomized order across participants

Secondary Outcomes (5)

• Brunoni safety scale

  Following each tIS session (day 8, 15)

• Wong-Baker safety scale

  Following each tIS session (day 8, 15)

• Pulvinar nucleus (PuN) tissue levels of N-acetyl aspartate (NAA)

  Once at baseline (day 1) and twice during each phase (day 8, 15): 1x following active stimulation, 1x following sham stimulation in randomized order across participants

• Pulvinar nucleus (PuN) tissue levels of glutathione (GSH)

  Once at baseline (day 1) and twice during each phase (day 8, 15): 1x following active stimulation, 1x following sham stimulation in randomized order across participants

• Columbia Suicide Severity Rating Scale (C-SSRS)

  Days 1, 8, 15, 22

Study Arms (3)

Active tIS 0.30 V/m and Sham

ACTIVE COMPARATOR

Group 1 with 10 participants to receive a dose of 0.30 V/m and sham. The order of the intervention will be randomized.

Device: Transcranial Interference Stimulation (tIS); Other: Sham tIS

Active tIS 0.35 V/m and Sham

ACTIVE COMPARATOR

Group 2 with 10 participants to receive a dose of 0.35 V/m and sham. The order of the intervention will be randomized.

Device: Transcranial Interference Stimulation (tIS); Other: Sham tIS

Active tIS 0.40 V/m and Sham

ACTIVE COMPARATOR

Group 3 with 10 participants to receive a dose of 0.40 V/m and sham. The order of the intervention will be randomized.

Device: Transcranial Interference Stimulation (tIS); Other: Sham tIS

Interventions

Transcranial Interference Stimulation (tIS) DEVICE

Field strength dose of 0.30 - 0.40 V/m

Also known as: Interference frequency stimulation (IFS), Transcranial Interference (TI)

Active tIS 0.30 V/m and Sham; Active tIS 0.35 V/m and Sham; Active tIS 0.40 V/m and Sham

Sham tIS OTHER

Sham transcranial interferential stimulation. Sham comparator to be administered to all groups.

Active tIS 0.30 V/m and Sham; Active tIS 0.35 V/m and Sham; Active tIS 0.40 V/m and Sham

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Columbia University Irving Medical Center/NewYork-Presbyterian Hospital (CUIMC/NYPH)

New York, New York, 10032, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 37857775 BACKGROUND

• 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.

  PMID: 28575667 BACKGROUND

Study Officials

• Daniel C Javitt, M.D., Ph.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel C Javitt, M.D., Ph.D.

CONTACT

1 6467745404; dcj2113@cumc.columbia.edu

Pejman Sehatpour, Ph.D.

CONTACT

1 6467745236; ps2723@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The blind will be maintained by the Nathan Kline Institute (NKI) Data management group. Treatment assignment will be transmitted from the NKI Data management group directly to an unblinded research technician who will supervise the stimulation but will not otherwise perform ratings. The research technician will be instructed not to discuss treatment assignment with other members of the research team.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 23, 2024
• Study Start: March 3, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Sharing will be in accordance with NIMH Data Archive (NDA) policies and procedures (https://nda.nih.gov/)
• Access Criteria: Data access will be in accordance with NIMH Data Archive (NDA) policies and procedures

Locations

US (1)