tDCS on Working Memory (WM) in Adults With ASD

NCT03255837 | Completed

• 1 other identifier: GN17MH365
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Transcranial Stimulation; Memory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Before stimulation

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

  After stimulation (1 week)

Study Arms (3)

Transcranial direct current stimulation (tDCS) - anodal

EXPERIMENTAL

Transcranial direct current stimulation - anodal (positive) 1.5 millamps for 15 minutes

Device: Transcranial direct current stimulation (tDCS)

Transcranial direct current stimulation (tDCS) - cathodal

EXPERIMENTAL

Transcranial direct current stimulation - cathodal (negative) 1.5 millamps for 15 minutes

Device: Transcranial direct current stimulation (tDCS)

Transcranial direct current stimulation (tDCS) - sham

SHAM COMPARATOR

Transcranial direct current stimulation - sham session 15 minutes

Device: Transcranial direct current stimulation (tDCS)

Interventions

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)

Transcranial direct current stimulation (tDCS) - anodal; Transcranial direct current stimulation (tDCS) - cathodal; Transcranial direct current stimulation (tDCS) - sham

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

University of Glasgow

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Craig Melville, MD

  University of Glasgo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of the order in which they receive the transcranial stimulation condition (anodal, cathodal, sham).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will receive the same 3 kinds of transcranial stimulation. However, the order in which they receive them will be randomly allocated.

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 21, 2017
• Study Start: February 26, 2018
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)