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Autism Spectrum DisorderNCT03255837

tDCS on Working Memory (WM) in Adults With ASD

A study testing Transcranial direct current stimulation (tDCS) in people with Autism Spectrum Disorder, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, men only
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Transcranial direct current stimulation (tDCS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteUnited Kingdom
Study dates
26 Feb 2018to 21 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University of Glasgow

    Glasgow

Other trials in United Kingdom

About this study

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

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.

Read the 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).

Being tested
Transcranial direct current stimulation (tDCS)
Keywords
Transcranial Stimulation, Memory
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial direct current stimulation (tDCS)Device

    Transcranial Direct Current Stimulation (tDCS, a form of non-invasive brain stimulation) on the left dorsolateral prefrontal cortex (DLPFC)

Study groups in NCT03255837
Study groupRoleWhat they receive
Transcranial direct current stimulation (tDCS) - anodalExperimentalTranscranial direct current stimulation - anodal (positive) 1.5 millamps for 15 minutes
Receives: Device: Transcranial direct current stimulation (tDCS)
Transcranial direct current stimulation (tDCS) - cathodalExperimentalTranscranial direct current stimulation - cathodal (negative) 1.5 millamps for 15 minutes
Receives: Device: Transcranial direct current stimulation (tDCS)
Transcranial direct current stimulation (tDCS) - shamSham comparatorTranscranial direct current stimulation - sham session 15 minutes
Receives: Device: Transcranial direct current stimulation (tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Working memory accuracy score compared to typically developed controls scores.

    Result of N-back memory task

    Measured: Change from baseline (before stimulation) to after stimulation (1 week)

Secondary outcomes (2)

  1. Difference in working memory accuracy score between adults with ASD and healthy controls

    Result of N-back memory task

    Measured: Before stimulation

  2. Difference in working memory accuracy score between adults with ASD and healthy controls

    Result of N-back memory task

    Measured: After stimulation (1 week)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2017
  2. Study start26 Feb 2018
  3. Primary completion21 Dec 2018
  4. Study completion21 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Participant
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03255837
Sponsor's protocol ID
GN17MH365
Status last verified
Jan 2019
First submitted
16 Aug 2017
Last updated
25 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial direct current stimulation (tDCS) in people with Autism Spectrum Disorder, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Working memory accuracy score compared to typically developed controls scores. (time frame: Change from baseline (before stimulation) to after stimulation (1 week)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03255837.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.

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tDCS on Working Memory (WM) in Adults With ASD | AzTrials