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Effects of Transcranial Direct Current Stimulation for Enhancing Cognitive Function in Individuals With Autism Spectrum Disorder - A Pilot fMRI Study

5. November 2026 aktualisiert von: Dr Yvonne Han, The Hong Kong Polytechnic University

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

    • Kowloon
      • Hung Hom, Kowloon, Hongkong
        • Rekrutierung
        • The Hong Kong Polytechnic University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre bis 21 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Männlich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.

Schein-Komparator: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Executive Functioning - Executive Composite Score
Zeitfenster: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)

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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in subdomains of executive function - CANTAB® cognitive test: Reaction Time (RTI)
Zeitfenster: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)

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)
Change in subdomains of executive function - CANTAB® cognitive test: Spatial Working Memory (SWM)
Zeitfenster: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)

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)
Change in CANTAB® cognitive test - Multitasking Test (MTT)
Zeitfenster: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)

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)
Change in CANTAB® cognitive test - Emotion Recognition Task (ERT)
Zeitfenster: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)

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)
Change in subdomains of executive function - Verbal Fluency Test (VFT)
Zeitfenster: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)

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)
Change in subdomains of executive function - Five-Point Test (FPT)
Zeitfenster: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)

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)
Change in subdomains of executive function - Color Trails Test (CTT)
Zeitfenster: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)

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)
Changes in subdomains of executive function - d2 Test of Attention
Zeitfenster: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)

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)
Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2)
Zeitfenster: First day of intervention, and 1 day after the last day of intervention (2 time points, up to 2 weeks)

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)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Exploratory mediator - Excitability-Inhibitory (E/I) ratio
Zeitfenster: First day of intervention, and 1 day after the last day of intervention. (2 time points, up to 2 weeks)

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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ermittler

  • Hauptermittler: Yvonne Han, The Hong Kong Polytechnic University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

16. November 2026

Primärer Abschluss (Geschätzt)

30. September 2027

Studienabschluss (Geschätzt)

30. September 2027

Studienanmeldedaten

Zuerst eingereicht

30. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. November 2026

Zuerst gepostet (Tatsächlich)

12. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. November 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • HSEARS20260821003

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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