Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524310
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-30
Brief Title:
Effects of rTMS on Cognitive Functions and Behavior in Individuals With Autism Spectrum Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Repetitive Transcranial Magnetic Stimulation rTMS on Cognitive Functions and Behavior in Individuals With Autism Spectrum Disorder ASD
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
Autism spectrum disorder ASD is a complex neurodevelopmental disorder with core symptoms that include impairments in social communication and restricted and repetitive behaviors interests and activities Social cognition is a broad term used to understand perceive and interpret information about others and ourselves in a social context Impairments in social cognition are often highlighted as a potential mechanism underlying social disability in autism spectrum disorder High-order cognitive functions such as Executive function EF and social cognition rely on neural network oscillations in the gamma frequency 30-80 Hz band It has been proposed that GABA-inhibitory interneurons in the dorsolateral prefrontal cortex DLPFC contribute to the synchronization of pyramidal neurons which is necessary for EF performance Impaired GABAergic neurotransmission within the DLPFC has been linked with altered gamma oscillatory activity and working memory deficits Transcranial magnetic stimulation TMS is one method used to deliver electrical stimuli through the scalp in conscious humans Recently rTMS is not only for the treatment of major depressive disorders but it has also been advanced as a potential therapeutic technique to treat neurologic disorders such as Parkinsons disease Huntingtons disease amyotrophic lateral sclerosis and multiple sclerosis and many other neuropsychiatric disorders It is still undetermined whether it is possible to improve the symptoms of ASD individuals through noninvasive neural modulation Previous studies in ASD indicate that rTMS applied to DLPFC can modulate gamma oscillatory activity
In this study the investigators aim to examine the effectiveness of low-frequency rTMS in improving social cognitive function and emotion recognition in ASD individuals
Further understanding of the effect of low-frequency rTMS in altering the cognitive function in ASD individuals may help to achieve some answers related to the mechanism behind ASD This stimulation protocol could be a vital therapeutic strategy for the treatment of ASD in future clinical practice
In this study the investigators aim to examine the effectiveness of low-frequency rTMS in improving social cognitive function and emotion recognition in ASD individuals
Further understanding of the effect of low-frequency rTMS in altering the cognitive function in ASD individuals may help to achieve some answers related to the mechanism behind ASD This stimulation protocol could be a vital therapeutic strategy for the treatment of ASD in future clinical practice
Detailed Description:
Statement of the Problem
Autism spectrum disorder ASD is a complex neurodevelopmental disorder Core ASD symptoms include impairments in social communication and restricted and repetitive behaviors interests and activities ASD may also present with secondary signs including hyperactivity self-injury and co-occurrence of some psychiatric conditions eg anxiety and major depression The symptoms of ASD are persistent and typically appear during the first three years of life It can be recognized and clinically evident in early childhood
In most cases but not all ASD symptoms might follow a steady course without remission However deficits and impairment in social skills and behavioral patterns may not be noticed and diagnosed as symptoms of ASD until the child faces significant life demands such as social educational and occupational tasks Moreover this functional limitation may vary among persons with ASD and could develop over time
In the past 50 years ASDs description has changed from a rare disease of childhood-onset to a well-publicized advocated and researched lifelong condition recognized as relatively common and very heterogeneous Since the 1970s several studies have reported increased ASD cases The report documented that the malefemale ratio is approximately 4 per 1 According to the Centers for Disease Control the prevalence of ASD increased from 1 in 80 125 in 2011-2013 to 1 in 45 224 in 2014 In the Gulf countries systematic review studies of the epidemiology of autism revealed a prevalence ranging from 14 to 2910000 persons In a study in Taif Saudi Arabia the estimated prevalence of autism in primary school children aged 7-12 years was 0035 Reviews of the literature have revealed no recent prevalence statistics for children with autismASD in Saudi Arabia The Saudi Ministry of Health has indicated that one in every 160 children has an ASD
ASDs are a financial emotional and social burden An autistic childs care causes more emotional burden to the parents than that of parents compared to that of parents taking care of terminally ill children
Social cognition is a broad term that describes cognitive processes related to perceiving understanding and implementing linguistic auditory visual and physical cues that communicate emotional and interpersonal information It is also defined as the perception of others the perception of self and interpersonal knowledge Its the ability to understand perceive and interpret information about others and ourselves in a social context It includes a wide range of processes that allow people to perceive and interpret rapidly changing social information and respond appropriately to social stimuli quickly effortlessly and flexibly Also social cognition ability gives meaning to the actions of others
Assessment of social cognition primarily focusing on four key domains like theory of mind ToM emotional empathy and social perception and behavior has been increasingly evaluated in clinical settings given the potential implications of impairments of these skills for therapeutic decision-making Cognitive impairment is defined as when a person has trouble remembering learning new things concentrating or making decisions that affect their everyday life The common signs of cognitive impairment may include loss of memory Asking the same question frequently or repeating the same story over and over unable to recognize familiar people or places having trouble exercising judgment such as knowing what to do in an emergency changes in mood or behavior difficulty in vision difficulty planning or carrying out tasks such as following a recipe or keeping track of monthly bills
Studies showed that alterations in social cognition ability were associated with autism autism severity and autistic traits Impairments in social cognition are often highlighted as a potential mechanism underlying social disability in autism spectrum disorder Different social skills programs have been developed for autistic adults based on the assumption that improving social understanding and ability will improve functional outcomes
Transcranial magnetic stimulation TMS is one method used to deliver electrical stimuli through the scalp in conscious humans Generally single-pulse TMS including paired-pulse TMS is used to explore brain functioning In contrast repetitive TMS rTMS is used to induce changes in brain activity that can last beyond the stimulation period Therefore TMS and rTMS are indirect and non-invasive methods to induce excitability changes in the motor cortex via a wire coil generating a magnetic field that passes through the scalp TMS Non-invasive TMS of the motor cortex leads to a twitch in the target muscle evoking motor-evoked potential MEP on electromyography As per the literature TMS might help regulate gamma oscillations reduce behavioral symptoms and normalize executive and autonomic dysfunction signs TMS is a valuable technique for assessing the underlying neurophysiology associated with several neuropathologies It is a unique tool for establishing potential neural mechanisms responsible for disease progression Recently rTMS has been advanced as a potential therapeutic technique to treat selected neurologic disorders Such neurological disorders include Parkinsons disease Huntingtons disease amyotrophic lateral sclerosis and multiple sclerosis
Moreover worldwide multiple studies have repeatedly demonstrated that TMS has antidepressant effects more significantly than sham treatment and that these effects are clinically meaningful For diagnostic uses TMS is a potential diagnostic tool in movement disorders TMS is used worldwide and represents a novel technique with both diagnostic and therapeutic potential TMS is used to study cortical excitability and intracortical inhibition and investigate cortical and cortico-spinal plasticity mechanisms implicated in ASD pathophysiology Published studies showing promising results concluded that specific rTMS protocols targeting particular regions of the cortex might lead to improvement in specific behavioral deficits in some individuals with ASD both the investigative and therapeutic results have been mixed rTMS and other electrical stimulation devices can modulate the brains functioning in either a facilitatory or suppressive manner and when applied over several sessions can have an additive effect lasting several months If theories are correct that cortical mechanisms of excitability connectivity and plasticity are abnormal in ASD then rTMS can modulate these mechanisms Overall in the hands of trained technicians rTMS might have great potential as both a diagnostic and therapeutic tool for ASD
Autism spectrum disorder ASD is a complex neurodevelopmental disorder Core ASD symptoms include impairments in social communication and restricted and repetitive behaviors interests and activities ASD may also present with secondary signs including hyperactivity self-injury and co-occurrence of some psychiatric conditions eg anxiety and major depression The symptoms of ASD are persistent and typically appear during the first three years of life It can be recognized and clinically evident in early childhood
In most cases but not all ASD symptoms might follow a steady course without remission However deficits and impairment in social skills and behavioral patterns may not be noticed and diagnosed as symptoms of ASD until the child faces significant life demands such as social educational and occupational tasks Moreover this functional limitation may vary among persons with ASD and could develop over time
In the past 50 years ASDs description has changed from a rare disease of childhood-onset to a well-publicized advocated and researched lifelong condition recognized as relatively common and very heterogeneous Since the 1970s several studies have reported increased ASD cases The report documented that the malefemale ratio is approximately 4 per 1 According to the Centers for Disease Control the prevalence of ASD increased from 1 in 80 125 in 2011-2013 to 1 in 45 224 in 2014 In the Gulf countries systematic review studies of the epidemiology of autism revealed a prevalence ranging from 14 to 2910000 persons In a study in Taif Saudi Arabia the estimated prevalence of autism in primary school children aged 7-12 years was 0035 Reviews of the literature have revealed no recent prevalence statistics for children with autismASD in Saudi Arabia The Saudi Ministry of Health has indicated that one in every 160 children has an ASD
ASDs are a financial emotional and social burden An autistic childs care causes more emotional burden to the parents than that of parents compared to that of parents taking care of terminally ill children
Social cognition is a broad term that describes cognitive processes related to perceiving understanding and implementing linguistic auditory visual and physical cues that communicate emotional and interpersonal information It is also defined as the perception of others the perception of self and interpersonal knowledge Its the ability to understand perceive and interpret information about others and ourselves in a social context It includes a wide range of processes that allow people to perceive and interpret rapidly changing social information and respond appropriately to social stimuli quickly effortlessly and flexibly Also social cognition ability gives meaning to the actions of others
Assessment of social cognition primarily focusing on four key domains like theory of mind ToM emotional empathy and social perception and behavior has been increasingly evaluated in clinical settings given the potential implications of impairments of these skills for therapeutic decision-making Cognitive impairment is defined as when a person has trouble remembering learning new things concentrating or making decisions that affect their everyday life The common signs of cognitive impairment may include loss of memory Asking the same question frequently or repeating the same story over and over unable to recognize familiar people or places having trouble exercising judgment such as knowing what to do in an emergency changes in mood or behavior difficulty in vision difficulty planning or carrying out tasks such as following a recipe or keeping track of monthly bills
Studies showed that alterations in social cognition ability were associated with autism autism severity and autistic traits Impairments in social cognition are often highlighted as a potential mechanism underlying social disability in autism spectrum disorder Different social skills programs have been developed for autistic adults based on the assumption that improving social understanding and ability will improve functional outcomes
Transcranial magnetic stimulation TMS is one method used to deliver electrical stimuli through the scalp in conscious humans Generally single-pulse TMS including paired-pulse TMS is used to explore brain functioning In contrast repetitive TMS rTMS is used to induce changes in brain activity that can last beyond the stimulation period Therefore TMS and rTMS are indirect and non-invasive methods to induce excitability changes in the motor cortex via a wire coil generating a magnetic field that passes through the scalp TMS Non-invasive TMS of the motor cortex leads to a twitch in the target muscle evoking motor-evoked potential MEP on electromyography As per the literature TMS might help regulate gamma oscillations reduce behavioral symptoms and normalize executive and autonomic dysfunction signs TMS is a valuable technique for assessing the underlying neurophysiology associated with several neuropathologies It is a unique tool for establishing potential neural mechanisms responsible for disease progression Recently rTMS has been advanced as a potential therapeutic technique to treat selected neurologic disorders Such neurological disorders include Parkinsons disease Huntingtons disease amyotrophic lateral sclerosis and multiple sclerosis
Moreover worldwide multiple studies have repeatedly demonstrated that TMS has antidepressant effects more significantly than sham treatment and that these effects are clinically meaningful For diagnostic uses TMS is a potential diagnostic tool in movement disorders TMS is used worldwide and represents a novel technique with both diagnostic and therapeutic potential TMS is used to study cortical excitability and intracortical inhibition and investigate cortical and cortico-spinal plasticity mechanisms implicated in ASD pathophysiology Published studies showing promising results concluded that specific rTMS protocols targeting particular regions of the cortex might lead to improvement in specific behavioral deficits in some individuals with ASD both the investigative and therapeutic results have been mixed rTMS and other electrical stimulation devices can modulate the brains functioning in either a facilitatory or suppressive manner and when applied over several sessions can have an additive effect lasting several months If theories are correct that cortical mechanisms of excitability connectivity and plasticity are abnormal in ASD then rTMS can modulate these mechanisms Overall in the hands of trained technicians rTMS might have great potential as both a diagnostic and therapeutic tool for ASD
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