Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607432
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Temporal Interference Stimulation for Social Cognition
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Use of Alpha-frequency Deep Transcranial Interference Stimulation tIS to Understand and Modify Temporal Dynamics of Face Emotion Recognition and Socialaffective Function
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 safetytolerability 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 safetytolerability 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 EEGtIS 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 EEGtIS 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None