tDCS on Working Memory (WM) in Adults With ASD

A Single Blind, Randomized Controlled Trial of Anodal Transcranial Direct-current Stimulation (tDCS) Against Cathodal and Sham Stimulation in Adults With High-Functioning Autism

This study will involve an experiment in individuals with Autism Spectrum Disorder (ASD) comparing their performance on a working memory task before, during and after non-invasive brain stimulation (tDCS) compared to a control group in a 3x3 factorial design. How the stimulation affects performance on the task will be assessed, along with the impact of the intervention on the individuals.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: Transcranial direct current stimulation (tDCS)

Detailed Description

Many studies have examined working memory in people with autism spectrum disorder as working memory deficits in individuals with autism spectrum disorder leads to multiple difficulties associated with behaviour regulation, cognitive flexibility, abstract thinking, and focusing and sustaining attention. Evidence suggests that transcranial Direct Current Stimulation on the left dorsolateral prefrontal cortex leads to an increase in working memory performance in typically developing individuals. This may have important benefits for people with autism spectrum disorder since autism spectrum disorder is known to be associated with working memory deficiencies. This study will build on a pilot study conducted in 2014, the experiment tested participants working memory scores on an N-back test, after receiving anodal (positive stimulation) stimulation for 15 minutes over the left dorsolateral prefrontal cortex. This task requires the participant to perform multiple cognitive operations, including encoding of new stimuli, updating and maintaining past stimuli, and recognising and responding to whether each new stimulus matches the three-back stimulus. Participants are presented with a random set of ten letters (from A-Z). A different letter will be displayed every 2s, participants will be required to respond (key press 1) if the presented letter was the same as the letter presented three stimuli previously (a target). If it was not a target, participants were required to respond with key press 2. In this test, a total of 30 correct responses are possible. Participants will perform the task three times to reduce variability. Accuracy (number of correct responses), error rate (number of incorrect responses), and reaction time (interval between target presentation and pressing 1 or 2) will be recorded. Based on the findings from the pilot study, a full study will be conducted to investigate the effects of anodal transcranial Direct Current Stimulation on adults with high-functioning autism, as well as test whether the effects of transcranial Direct Current Stimulation on dorsolateral prefrontal cortex is dependent on polarity (anodal versus cathodal (negative stimulation) stimulation).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • University of Glasgow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• clinical diagnosis of ASD
• right handed
• speaks English fluently
• normal vision or corrected to normal
• passing tDCS safety screening

Exclusion Criteria:

• participants who do not understand verbal or written English (i.e would be in need of translators)
• participants that have ever suffered from epilepsy, febrile convulsions in infancy or had recurrent fainting spells
• family history of epilepsy
• has a heart pacemaker, cochlear implant, medication pump, surgical clips
• has drunk more than 3 units of alcohol in the last 24 hours
• suffers from migraines
• metal in the head, implanted brain medical devices
• has undergone a neurosurgical procedure
• has had more than one cup of coffee, or other sources of caffeine in the last hour
• taking any unprescribed or prescribed medication that might effect tDCS
• medications or psychoactive drugs that can lower seizure threshold [imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel dust), ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline]
• withdrawal from alcohol, barbiturates, benzodiazepines, meprobamate, chloral hydrate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Transcranial direct current stimulation (tDCS) - anodal; Transcranial direct current stimulation - anodal (positive) 1.5 millamps for 15 minutes	Device: Transcranial direct current stimulation (tDCS); Transcranial Direct Current Stimulation (tDCS, a form of non-invasive brain stimulation) on the left dorsolateral prefrontal cortex (DLPFC)
EXPERIMENTAL: Transcranial direct current stimulation (tDCS) - cathodal; Transcranial direct current stimulation - cathodal (negative) 1.5 millamps for 15 minutes	Device: Transcranial direct current stimulation (tDCS); Transcranial Direct Current Stimulation (tDCS, a form of non-invasive brain stimulation) on the left dorsolateral prefrontal cortex (DLPFC)
SHAM_COMPARATOR: Transcranial direct current stimulation (tDCS) - sham; Transcranial direct current stimulation - sham session 15 minutes	Device: Transcranial direct current stimulation (tDCS); Transcranial Direct Current Stimulation (tDCS, a form of non-invasive brain stimulation) on the left dorsolateral prefrontal cortex (DLPFC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Working memory accuracy score compared to typically developed controls scores.	Result of N-back memory task	Change from baseline (before stimulation) to after stimulation (1 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in working memory accuracy score between adults with ASD and healthy controls	Result of N-back memory task	Before stimulation
Difference in working memory accuracy score between adults with ASD and healthy controls	Result of N-back memory task	After stimulation (1 week)

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Glasgow
• Investigators: Study Director: Craig Melville, MD, University of Glasgo

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 26, 2018
• Primary Completion (ACTUAL): December 21, 2018
• Study Completion (ACTUAL): December 21, 2018

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (ACTUAL): August 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Memory; Transcranial Stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: GN17MH365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No