- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07931781
Effects of Transcranial Direct Current Stimulation for Enhancing Cognitive Function in Individuals With Autism Spectrum Disorder - A Pilot fMRI Study
Autism Spectrum Disorder (ASD) is a pervasive neurodevelopmental disorder that currently affects 1 in 32 children. ASD is characterized by persistent deficits in social communication and restricted, repetitive behaviors. For instance, people with ASD often show great difficulty in recognizing social cues and understanding others' emotions, as well as having a tendency to act inflexibly and inappropriately in social situations, all of which contribute to lifelong social and occupational dysfunctions.To date, there is no cure for ASD. Existing treatments are primarily behavioral or educational based. Although some treatments show positive therapeutic effects in reducing patients' core autistic symptoms, the interventions are often labor- and time-intensive. Recently, a non-invasive painless brain stimulation technique, "transcranial direct current stimulation (tDCS)," has received increasing interest in clinical settings as a potential tool for cognitive enhancement and neurorehabilitation for various cognitive dysfunctions. This study aims to examine the effectiveness of tDCS treatment combined with cognitive training for individuals with ASD. We will study the effect before and after treatment.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Yvonne Han, PhD
- Telefonní číslo: +852 2766 7578
- E-mail: yvonne.han@polyu.edu.hk
Studijní místa
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Kowloon
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Hung Hom, Kowloon, Hongkong
- Nábor
- The Hong Kong Polytechnic University
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Kontakt:
- Yvonne Han, PhD
- Telefonní číslo: +852 2766 7578
- E-mail: yvonne.han@polyu.edu.hk
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 12-21 years old;
- Score of 60 or above on an intelligence test;
- Able to communicate in Chinese;
- Diagnosed with Autism Spectrum Disorder (ASD)
Exclusion Criteria:
- Diagnosed with Developmental Coordination Disorder (DCD);
- Diagnosed with other neurological or psychiatric disorders;
- Previous history of brain-stimulation-induced mental or psychological disorder;
- Presence of metal or other types of implants;
- Suffers from claustrophobia, or is unable to stay still in confined or narrow spaces
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Active-tDCS
For the active-tDCS condition, participants will receive a stimulation on the dorsolateral prefrontal cortex, with ramp up and ramp down mode for 30 seconds, eliciting a tingling sensation on the scalp that fades over seconds. |
Participants will receive active-tDCS over 10 sessions in 2 weeks (20 minutes per session, once per day, for 10 consecutive working days), with concurrent computerized cognitive training. The training comprises of 10 games targeting multiple executive functions. |
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Falešný srovnávač: Sham-tDCS
For sham-tDCS condition, participants will receive an initial stimulation of a ramp up and ramp down mode for 30 seconds, eliciting a tingling sensation on the scalp. Then the stimulation will be discontinued. |
Participants will receive sham-tDCS over 10 sessions in 2 weeks (20 minutes per session, once per day, for 10 consecutive working days), with concurrent computerized cognitive training. The training comprises of 10 games targeting multiple executive functions. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Executive Functioning - Executive Composite Score
Časové okno: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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Derived by summing the scores from the test battery of executive functions. To reduce the number of statistical comparisons, one Executive Composite score will be computed from the different executive function measures. This will be done by converting the raw scores on the different executive function measures to Z scores. The Z scores from the different executive function measures will then be averaged to yield the Executive Composite score. Lower scores indicate poorer executive functioning. |
First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in subdomains of executive function - CANTAB® cognitive test: Reaction Time (RTI)
Časové okno: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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RTI assesses motor and mental response speeds, reaction time, response accuracy and impulsivity. It consists of 30 trials with five potential targets and requires participants to make flexible responses as fast as possible to the target stimulus (shown in yellow). Specifically, movement and reaction time will be measured, where shorter duration reflects faster processing |
First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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Change in subdomains of executive function - CANTAB® cognitive test: Spatial Working Memory (SWM)
Časové okno: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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SWM assess the memory ability of visuospatial information. Participants are required to search the tokens from a number of boxes but not pressing the boxes which tokens have been found. Errors (lower scores indicate lower repetition on pressing the same boxes that token has been found) and strategy (lower scores suggest higher strategy use in begin of choosing the same boxes) will be measured. |
First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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Change in CANTAB® cognitive test - Multitasking Test (MTT)
Časové okno: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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MTT assesses the ability to resolve the interference of task-irrelevant information (stroop-like effect). The test displays an arrow which can appear on either the left or right side of the screen and can point to either the left or right side. In each trial, participants are presented with a cue that indicates which button to press according to two different rules. And the rules that participants have to follow may change from trial to trial in a randomized order. Participant's response latencies and error scores will be measured. |
First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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Change in CANTAB® cognitive test - Emotion Recognition Task (ERT)
Časové okno: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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ERT assesses the ability to identify six basic emotions in facial expressions along a continuum of expression magnitude. Participants must select which emotion the facial image displayed 0.2s ago. Response latencies and accuracy will be measured. |
First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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Change in subdomains of executive function - Verbal Fluency Test (VFT)
Časové okno: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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The VFT assesses an individual's ability of working memory retrieval and executive control by instructing the individual to generate words for given semantic categories within a limited time. Participants will be given one minute for each category, which will be counterbalanced across participants to avoid order effects. The number of unique and correct words generated will be counted for each of the participants. |
First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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Change in subdomains of executive function - Five-Point Test (FPT)
Časové okno: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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The FPT assess an individual's design fluency and mental flexibility through instructing the individual to create unique, geometric patterns. Participants will be given a sheet of paper containing an array of 40 identical boxes. Each box contains 5 dots, arranged in the same pattern as '5' on a standard die. Participants have to connect 2 or more of the 5 dots using straight lines to create as many unique designs as possible within 5 minutes. The number of unique and correct patterns generated will be counted for each of the participants at 3 minutes and 5 minutes. |
First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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Change in subdomains of executive function - Color Trails Test (CTT)
Časové okno: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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CTT is a test that measures attention, processing speed, and flexibility. In Part 1, participants will connect numbered circles in sequential order as fast as possible. In Part 2, participants will also numbers in order, but must also alternate between circles of two different colors (pink and yellow). The execution time will be measured. |
First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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Changes in subdomains of executive function - d2 Test of Attention
Časové okno: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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The d2 Test of Attention measures selective and sustained attention, as well as visual information processing. Participants will be given 14 rows with 40 characters each, of which they must scan each row and cross out every target item (the letter 'd' with 2 dashes either above, below, or one in each position). Therefore, participants much ignore distractors along each row (i.e. the letter 'p' with any number of dashes, or 'd' with the wrong number of dashes). The number of errors will be counted for each participant. |
First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2)
Časové okno: First day of intervention, and 1 day after the last day of intervention (2 time points, up to 2 weeks)
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SRS-2 is a sensitive measure of social functioning in individuals that detects even subtle symptoms that are highly related to ASD. It uses a four-point scale and focuses on different aspects of socialization. The total score reflects the clinical effectiveness of tDCS, and higher scores indicate greater symptom severity. It has been shown that SRS-2 is sensitive to detect changes in social communication improvement related to improved cognitive functioning after treatment. |
First day of intervention, and 1 day after the last day of intervention (2 time points, up to 2 weeks)
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Exploratory mediator - Excitability-Inhibitory (E/I) ratio
Časové okno: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
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The study proposed will examine the biological mediator variable, E/I ratio, to explain the effects of tDCS. MRI data will be collected in the resting-state before and immediately after the 10-session intervention program. Further network analysis will be performed to characterize broader shifts in functional brain connectivity. |
First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Yvonne Han, The Hong Kong Polytechnic University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HSEARS20260821003
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