Temporal Interference Stimulation for Social Cognition

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06607432
Status
Recruiting
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Conditions

  • Healthy Controls

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Transcranial Interference Stimulation (tIS) — DEVICE
    Field strength dose of 0.30 - 0.40 V/m
  • Sham tIS — OTHER
    Sham transcranial interferential stimulation. Sham comparator to be administered to all groups.

Study Details

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.

Key Dates

Start date
Mar 3, 2025
Status verified
Apr 2026
Primary completion
Dec 1, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY

Arms

  • 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.

Primary Outcome Measure

Pulvinar nucleus (PuN) activation levels [ Time Frame: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital (CUIMC/NYPH)New YorkNew York10032
Daniel C Javitt, M.D., Ph.D.
[email protected]
1 6467745404
Pejman Sehatpour, Ph.D.
[email protected]
1 6467745236
Daniel C Javitt, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Pejman Sehatpour, Ph.D. (SUB_INVESTIGATOR)
Christoph Juchem, Ph.D. (SUB_INVESTIGATOR)

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By research site
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital (CUIMC/NYPH)· New York, NY

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