Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-02 @ 11:34 AM
Study NCT ID:
NCT06607432
Status:
RECRUITING
Last Update Posted:
2025-08-20
First Post:
2024-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Temporal Interference Stimulation for Social Cognition
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TISSC
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 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.
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.
Detailed 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 only. In this stage, safety and tolerability will be assessed along with initial evaluation of target engagement. This stage uses a single ascending dose design with 10 participants per dose at each of three doses.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1U01MH135436 | NIH | None | https://reporter.nih.gov/quic… | View |