tDCS on Working Memory (WM) in Adults With ASD
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS)
Sponsored by
About this trial
This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring Transcranial Stimulation, Memory
Eligibility Criteria
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
Sites / Locations
- University of Glasgow
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Transcranial direct current stimulation (tDCS) - anodal
Transcranial direct current stimulation (tDCS) - cathodal
Transcranial direct current stimulation (tDCS) - sham
Arm Description
Transcranial direct current stimulation - anodal (positive) 1.5 millamps for 15 minutes
Transcranial direct current stimulation - cathodal (negative) 1.5 millamps for 15 minutes
Transcranial direct current stimulation - sham session 15 minutes
Outcomes
Primary Outcome Measures
Working memory accuracy score compared to typically developed controls scores.
Result of N-back memory task
Secondary Outcome Measures
Difference in working memory accuracy score between adults with ASD and healthy controls
Result of N-back memory task
Difference in working memory accuracy score between adults with ASD and healthy controls
Result of N-back memory task
Full Information
NCT ID
NCT03255837
First Posted
August 16, 2017
Last Updated
January 23, 2019
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
1. Study Identification
Unique Protocol Identification Number
NCT03255837
Brief Title
tDCS on Working Memory (WM) in Adults With ASD
Official Title
A Single Blind, Randomized Controlled Trial of Anodal Transcranial Direct-current Stimulation (tDCS) Against Cathodal and Sham Stimulation in Adults With High-Functioning Autism
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
December 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Transcranial Stimulation, Memory
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each participant will receive the same 3 kinds of transcranial stimulation. However, the order in which they receive them will be randomly allocated.
Masking
Participant
Masking Description
Participants will be unaware of the order in which they receive the transcranial stimulation condition (anodal, cathodal, sham).
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcranial direct current stimulation (tDCS) - anodal
Arm Type
Experimental
Arm Description
Transcranial direct current stimulation - anodal (positive) 1.5 millamps for 15 minutes
Arm Title
Transcranial direct current stimulation (tDCS) - cathodal
Arm Type
Experimental
Arm Description
Transcranial direct current stimulation - cathodal (negative) 1.5 millamps for 15 minutes
Arm Title
Transcranial direct current stimulation (tDCS) - sham
Arm Type
Sham Comparator
Arm Description
Transcranial direct current stimulation - sham session 15 minutes
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS)
Intervention Description
Transcranial Direct Current Stimulation (tDCS, a form of non-invasive brain stimulation) on the left dorsolateral prefrontal cortex (DLPFC)
Primary Outcome Measure Information:
Title
Working memory accuracy score compared to typically developed controls scores.
Description
Result of N-back memory task
Time Frame
Change from baseline (before stimulation) to after stimulation (1 week)
Secondary Outcome Measure Information:
Title
Difference in working memory accuracy score between adults with ASD and healthy controls
Description
Result of N-back memory task
Time Frame
Before stimulation
Title
Difference in working memory accuracy score between adults with ASD and healthy controls
Description
Result of N-back memory task
Time Frame
After stimulation (1 week)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Melville, MD
Organizational Affiliation
University of Glasgo
Official's Role
Study Director
Facility Information:
Facility Name
University of Glasgow
City
Glasgow
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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tDCS on Working Memory (WM) in Adults With ASD
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