Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362200
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-03-18
Brief Title:
The Validation and Biological Index Studies on the Improved Social Function of ASD by 40 Hz tACS
Sponsor:
Central South University
Organization:
Central South University
Study Overview
Official Title:
The Validation and Biological Index Studies on the Improved Social Function of Autism Spectrum Disorder by 40 Hz Transcranial Alternating Current Stimulation
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
In this proposed study tACS will be used to intervene in the autism spectrum disorders of children and adolescents and the efficacy of this intervention method will be evaluated as well as the internal mechanism of adolescents autism spectrum disorders will be discussed
Detailed Description:
The objective of this clinical study is to investigate the effects and mechanisms of transcranial alternating current stimulation tACS on neural modulation in the right temporoparietal junction rTPJ of autism spectrum disorders The primary inquiry it seeks to address is the impact of tACS the treatment of autism spectrum disorders ASD through its influence on the rTPJ Participants will undergo baseline assessments of clinical symptoms and cognitive levels utilize electroencephalography EEG to monitor brain electrical activity during both resting and task states analyze EEG neurophysiological characteristics use eye tracking technology to collect data on participants eye movements during cognitive tasks employ functional magnetic resonance spectroscopy fMRS to detect neurotransmitters such as glutamate glutamine Glx GABA macromolecules GABA and taurine in resting state and Theory of Mind task as well as utilize magnetic resonance imaging MRI to detect and analyze functional connectivity and synchronous activation of relevant brain regions during both resting state and task state Following completion of baseline assessment and examination participants will be randomly assigned into two groups a 40 Hz tACS group and a sham stimulation group with 30 patients in each group for a total of 60 patients Subjects in the tACS group will receive tACS intervention at 20mA with a frequency of 40Hz while subjects in the sham group will receive placebo stimulation at a similar location and frequency with no current between periods Standardized assessment tools along with Theory of Mind tasks will be utilized to evaluate multidimensional changes in clinical symptoms and cognitive levels post-intervention Additionally EEG will again be used to monitor brain electrical activity during both resting and task states by analyzing functional EI values fEI as well as indicators of EEG oscillatory activity such as α- power γ-power etc Eye tracker data analysis will also be conducted again for changes in eye fixation during cognitive tasks while fMRS analysis will focus on changes in neurotransmitters Furthermore MRI analysis post-intervention aims to examine changes in functional connectivity along with synchronous activation within rTPJ region alongside related brain regions once more Researchers aim to validate the efficacy safety profile associated with 40 Hz tACS intervention within rTPJ for treating social impairment observed within ASD population whilst exploring biological indicators mechanisms underlying effective treatment strategies involving 40 Hz tACS intervention program
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