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Cerebellar tDCS in Children with Autism Spectrum Disorder: Raynor Cerebellum Project
Study ID: STU-2022-0689
Summary
The study will be randomized, double-blind, within subject crossover design. it will involve a group of 30-40 children and young adults with aSD. We may recruit up to 60 subjects. Diagnosis of aSD will be confirmed with the autism Diagnostic interview-Revised (aDi-R) or autism Diagnostic observation Schedule-2 (aDoS-2) by a research-reliable clinician. each participant will undergo a sham condition and a tDCS condition, the order of sham and tDCS conditions will be randomly assigned to each participant during baseline testing. Sham refers to participants only receiving 1 ma of tDCS stimulation for 1 minute, and tDCS stimulation refers to 20 minutes of tDCS stimulation. The study involves an initial screening visit followed by two sessions with three months between each session period. each session includes the following: pre-testing and imaging, tDCS 3-week session, post-testing and imaging. Participants will complete an initial screening to confirm clinical diagnosis of aSD, determine baseline cognitive functioning, and complete a practice MRi and MeG session. at pre-testing, they will complete a psychometric battery, as well as undergo safety screening, and an MRi and/or MeG. each 3-week tDCS sessions will be randomized, and each participant will undergo three weeks of sham stimulation and three weeks of 20-minute tDCS stimulation. neither the researchers nor the participants will know which group they are assigned during each three-week session.
- Cancer Related
- No
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- PETER TZU-SHIN TSAI
TEMPORARY
The purpose of this research study is to investigate the effects of transcranial direct current stimulation (tDCS) on some of the challenges faced by children with autism Spectrum Disorder (aSD). autism spectrum disorder is a neurodevelopmental disorder characterized by deficits in social cognition, language, and repetitive/stereotyped behaviors. it is common across the globe and can have profound effects on patients and their families. There is no cure and current treatments center on behavioral therapies, along with use of medications for co-morbid conditions such as anxiety, oCD, and depression. Research consistently demonstrates the presence of cerebellar abnormalities in aSD, especially in the right crus i/ii area of the cerebellum. in addition, cerebellar-cortical circuits have been demonstrated to be altered and may contribute to symptoms in individuals with aSD. Recent evidence has shown that non-invasive brain stimulation can be a safe and effective therapeutic tool in numerous neuropsychiatric disorders including aSD. Several studies have shown that non-invasive brain stimulation is both efficacious and safe in pediatric populations and that non-invasive stimulation to the cerebellum in adults is both safe and effective in treating a number of neuropsychiatric conditions including schizophrenia. Multiple methods of non-invasive stimulation have been utilized, with the two most common types of non-invasive brain stimulation being transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). The latter requires significantly reduced equipment and increased convenience while providing safety and efficacy in multiple studies including aSD. However, there is currently limited evidence on the efficacy of non-invasive stimulation of the cerebellum in children, especially in children with aSD, and these are goals which we aim to delineate in this study. The primary objectives of the present study are as follows: 1. To observe the impacts and outcome of cerebellar transcranial direct current stimulation (tDCS) on social behaviors as measured by the Cyberball Task and Reading the Mind in the eyes (RMe) 2. To observe the impacts and outcome of cerebellar transcranial direct current stimulation (tDCS) on sensorimotor behavior as measured by grip strength, reach task, and the Sensory Profile-2 3. To observe the neurophysiological impacts of cerebellar tDCS through MeG and fMRi The secondary objectives of the present study are as follows: 1. To observe the impacts and outcome of cerebellar transcranial direct current stimulation (tDCS) on executive functioning as measured by the following niH toolbox subtests: Flanker inhibitory Control and attention and Dimensional Card Change Sort 2. To observe the impacts and outcome of cerebellar transcranial direct current stimulation (tDCS) on working memory as measured by the Stanford Binet-V Working Memory Subtest
