Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04798274
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2021-03-12
Brief Title:
Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder
Status:
RECRUITING
Status Verified Date:
2024-09-10
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:
None
Brief Summary:
Background
Autism spectrum disorder ASD is a complex neurodevelopmental syndrome Researchers think brain development may be controlled by gamma-aminobutyric acid GABA They want to learn how abnormalities in the GABA system may contribute to ASD
Objective
To see if repetitive transcranial magnetic stimulation rTMS creates short-term changes in how different parts of the brain communicate
Eligibility
Right-handed people ages 14-17 with ASD and healthy volunteers ages 18-25
Design
Participants will be screened with
Medical history
Physical exam
Medicine review
Neurological exam
Psychological tests and rating scales
Forms and surveys
Participants will have a hearing test and ear exam
Participants will have magnetic resonance imaging MRI of the brain They will lie on a table that moves in and out of the MRI scanner They may look at a screen while in the scanner A coil will be placed over their head
Participants will have magnetic resonance spectroscopy It takes pictures of chemicals in the brain using the MRI scanner
Participants will have magnetoencephalography They will sit in a chair A helmet with magnetic field sensors will be placed on their head
Participants will have TMS A wire coil will be held on their scalp A brief electrical current will pass through the coil
Participants will have electromyography Sticky pad electrodes will be placed on the skin during TMS The electrical activity of their muscles will be measured
Participants will have rTMS It uses short bursts of magnetic pulses to affect brain activity
ASD participants will have 7 visits over 2-3 months Healthy volunteers will have 3 visits over 3-4 weeks
Autism spectrum disorder ASD is a complex neurodevelopmental syndrome Researchers think brain development may be controlled by gamma-aminobutyric acid GABA They want to learn how abnormalities in the GABA system may contribute to ASD
Objective
To see if repetitive transcranial magnetic stimulation rTMS creates short-term changes in how different parts of the brain communicate
Eligibility
Right-handed people ages 14-17 with ASD and healthy volunteers ages 18-25
Design
Participants will be screened with
Medical history
Physical exam
Medicine review
Neurological exam
Psychological tests and rating scales
Forms and surveys
Participants will have a hearing test and ear exam
Participants will have magnetic resonance imaging MRI of the brain They will lie on a table that moves in and out of the MRI scanner They may look at a screen while in the scanner A coil will be placed over their head
Participants will have magnetic resonance spectroscopy It takes pictures of chemicals in the brain using the MRI scanner
Participants will have magnetoencephalography They will sit in a chair A helmet with magnetic field sensors will be placed on their head
Participants will have TMS A wire coil will be held on their scalp A brief electrical current will pass through the coil
Participants will have electromyography Sticky pad electrodes will be placed on the skin during TMS The electrical activity of their muscles will be measured
Participants will have rTMS It uses short bursts of magnetic pulses to affect brain activity
ASD participants will have 7 visits over 2-3 months Healthy volunteers will have 3 visits over 3-4 weeks
Detailed Description:
Study Description
This will be a within-subject controlled proof-of-mechanism study
Objectives
The study aims to evaluate the relationship between local GABA concentration structural and functional network connectivity and MEG measures of auditory and language processing in adolescents with ASD and the acute impact of a single session of continuous theta burst stimulation over left posterior superior temporal cortex pSTC on these measures We hypothesize that GABA concentrations DWI measures of tissue microstructure and fcMRI obtained BOLD correlations within the language network will significantly contribute to the prediction model for MEG indices of auditory and language processing Participation in the study involves about seven study visits Some of the visits may be split up to shorten the length of session and limit fatigue Visits will be scheduled about once a week All visits must be completed within six months of the date of enrollment
Primary Objective The overall goal of the current study is to 1 Characterize the relationship between an individuals baseline local cortical GABA concentration DWI measures of auditory and language network tissue microstructure and fcMRI indices of local and long-range network functional connectivity predictor variables and MEG indices of auditory and language processing dependent variables
Secondary Objectives 2 Evaluate the impact of a single session of cTBS over the left pSTC on these MRS and MEG indices in adolescents age 14-17 with ASD
Exploratory Objective 3 Characterize the relationship between the neuroimaging and electrophysiological indices obtained in this study and baseline behavioral symptom presentation
Endpoints
Primary Endpoints
1 MEG Evoked fields and Spectral Power
2 MRS GABACr concentrations in the left pSTC
3 DWI Diffusion derived parameters in the auditory radiations and arcuate fasciculus
4 fcMRI BOLD correlations across pre-defined ROIs
Secondary Endpoints
a MEG Inter-trial gamma-band coherence ITC and resting state alpha to gamma phase-amplitude coupling
Exploratory Endpoints
a SRS-2 CELF-5 EVT-3 PPVT-5 ADOS-2 if available ADI-R VABS-III WASI-II CBCL
This will be a within-subject controlled proof-of-mechanism study
Objectives
The study aims to evaluate the relationship between local GABA concentration structural and functional network connectivity and MEG measures of auditory and language processing in adolescents with ASD and the acute impact of a single session of continuous theta burst stimulation over left posterior superior temporal cortex pSTC on these measures We hypothesize that GABA concentrations DWI measures of tissue microstructure and fcMRI obtained BOLD correlations within the language network will significantly contribute to the prediction model for MEG indices of auditory and language processing Participation in the study involves about seven study visits Some of the visits may be split up to shorten the length of session and limit fatigue Visits will be scheduled about once a week All visits must be completed within six months of the date of enrollment
Primary Objective The overall goal of the current study is to 1 Characterize the relationship between an individuals baseline local cortical GABA concentration DWI measures of auditory and language network tissue microstructure and fcMRI indices of local and long-range network functional connectivity predictor variables and MEG indices of auditory and language processing dependent variables
Secondary Objectives 2 Evaluate the impact of a single session of cTBS over the left pSTC on these MRS and MEG indices in adolescents age 14-17 with ASD
Exploratory Objective 3 Characterize the relationship between the neuroimaging and electrophysiological indices obtained in this study and baseline behavioral symptom presentation
Endpoints
Primary Endpoints
1 MEG Evoked fields and Spectral Power
2 MRS GABACr concentrations in the left pSTC
3 DWI Diffusion derived parameters in the auditory radiations and arcuate fasciculus
4 fcMRI BOLD correlations across pre-defined ROIs
Secondary Endpoints
a MEG Inter-trial gamma-band coherence ITC and resting state alpha to gamma phase-amplitude coupling
Exploratory Endpoints
a SRS-2 CELF-5 EVT-3 PPVT-5 ADOS-2 if available ADI-R VABS-III WASI-II CBCL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20-M-0159 | None | None | None |