Neurostimulation for Cognitive Rehabilitation in Autistic Spectrum Disorders

NCT03947086 | Unknown DMC

• 1 other identifier: U1111-1221-6178
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a clinical trial aims investigate the effects of neurostimulation in the treatment of children with mild ASD, specifically the action of tDCS on social cognition skills. tDCS can modulate neuronal activity in patients with ASD. Specifically, this technique has shown to be a promising tool in the promotion of social neuroplasticity, aiming at more adaptive social interactions. In this sense, it was hypothesized that participants treated with active tDCS will present better performance in social cognition tests than those submitted to sessions with simulated current.

Conditions

Autistic Disorders Spectrum

Keywords

Autistic disorder; Neuromodulation; Social cognition; Executive functions; Eye tracking

Outcome Measures

Primary Outcomes (9)

• Facial emotion recognition

  Images of facial expressions of emotion of children of diverse ethnicities will be presented. We used 20 images of emotional expressions of the test of emotional knowledge elaborated by Izard, Hankins, Schultz, Tentracosta and King (2003). The following emotional faces of both sexes will be used: happy, sad, angry, fear / surprised and neutral, presented at random and for 4 seconds each. During the recognition of the emotional expressions, the 300 Hz binocular Eye Tracker Tobii was used to monitor eye movements. .

  The test will be measured immediately before the intervention.

• Facial emotion recognition

  Images of facial expressions of emotion of children of diverse ethnicities will be presented. We used 20 images of emotional expressions of the test of emotional knowledge elaborated by Izard, Hankins, Schultz, Tentracosta and King (2003). The following emotional faces of both sexes will be used: happy, sad, angry, fear / surprised and neutral, presented at random and for 4 seconds each. During the recognition of the emotional expressions, the 300 Hz binocular Eye Tracker Tobii was used to monitor eye movements. .

  The test will be measured immediately after the intervention.

• Facial emotion recognition

  Images of facial expressions of emotion of children of diverse ethnicities will be presented. We used 20 images of emotional expressions of the test of emotional knowledge elaborated by Izard, Hankins, Schultz, Tentracosta and King. The following emotional faces of both sexes will be used: happy, sad, angry, fear / surprised and neutral, presented at random and for 4 seconds each. During the recognition of the emotional expressions, the 300 Hz binocular Eye Tracker Tobii was used to monitor eye movements. .

  The test will be measured 4 weeks after the intervention.

• Theory of mind- Verbal task

  The subtest theory of mind contained in Nepsy II neuropsychological battery will be used. The test includes two tasks: the verbal task evaluates the understanding and perception of self-intention and of the other, deception, beliefs, pretending, and imitation through stories, figures, and questions. The contextual task evaluates the ability to relate a situation to emotion in a specific social context.

  The test will be measured immediately before the intervention.

• Theory of mind- Contextual task

  The subtest theory of mind contained in Nepsy II neuropsychological battery will be used. The test includes two tasks: the verbal task evaluates the understanding and perception of self-intention and of the other, deception, beliefs, pretending, and imitation through stories, figures, and questions. The contextual task evaluates the ability to relate a situation to emotion in a specific social context.

  The test will be measured immediately before the intervention.

• Theory of mind- Verbal task

  The subtest theory of mind contained in Nepsy II neuropsychological battery will be used. The test includes two tasks: the verbal task evaluates the understanding and perception of self-intention and of the other, deception, beliefs, pretending, and imitation through stories, figures, and questions. The contextual task evaluates the ability to relate a situation to emotion in a specific social context.

  The test will be measured immediately after the intervention.

• Theory of mind- Contextual task

  The subtest theory of mind contained in Nepsy II neuropsychological battery will be used. The test includes two tasks: the verbal task evaluates the understanding and perception of self-intention and of the other, deception, beliefs, pretending, and imitation through stories, figures, and questions. The contextual task evaluates the ability to relate a situation to emotion in a specific social context.

  The test will be measured immediately after the intervention.

• Theory of mind- Verbal task

  The subtest theory of mind contained in Nepsy II neuropsychological battery will be used. The test includes two tasks: the verbal task evaluates the understanding and perception of self-intention and of the other, deception, beliefs, pretending, and imitation through stories, figures, and questions. The contextual task evaluates the ability to relate a situation to emotion in a specific social context.

  The test will be measured 4 weeks after the intervention.

• Theory of mind- Contextual task

  The subtest theory of mind contained in Nepsy II neuropsychological battery will be used. The test includes two tasks: the verbal task evaluates the understanding and perception of self-intention and of the other, deception, beliefs, pretending, and imitation through stories, figures, and questions. The contextual task evaluates the ability to relate a situation to emotion in a specific social context.

  The test will be measured 4 weeks after the intervention.

Secondary Outcomes (9)

• Memory for Digit Span

  The test will be measured immediately before the intervention.

• Memory for Digit Span

  The test will be measured immediately after the intervention.

• Memory for Digit Span

  The test will be measured 4 weeks after the intervention.

• Trail Making Test A e B

  The test will be measured immediately before the intervention.

• Trail Making Test A e B

  The test will be measured immediately after the intervention.

Study Arms (2)

Active TDCS Group

ACTIVE COMPARATOR

Participants will receive active Transcranial Direct Current Stimulation (TDCS) (1.5 mA). Furthermore, everyone will receive Social Cognition Training concomitantly with neurostimulation to enhance social skills.

Device: Transcranial Direct Current Stimulation (TDCS)- Active; Behavioral: Cognitive Training

Sham tDCS Group

SHAM COMPARATOR

Participants will receive sham TDCS. The protocol is identical for placebo stimulation, but the current will stop after 30 seconds from the start of stimulation. Furthermore, everyone will receive Social Cognition Training concomitantly with neurostimulation to enhance social skills.

Device: Transcranial Direct Current Stimulation (TDCS)- Sham; Behavioral: Cognitive Training

Interventions

Transcranial Direct Current Stimulation (TDCS)- Active DEVICE

A constant current stimulator (TCT Research Limited) will be used using electrodes of 5 × 5 cm2 embedded in saline (0.9 % NaCl) and application of 1.5 mA current for 20 minutes for 5 consecutive days. The cathode will be positioned in the right supra-orbital region, and while the anode will have the following provision in the left dorsolateral prefrontal cortex (F3).

Active TDCS Group

Transcranial Direct Current Stimulation (TDCS)- Sham DEVICE

The protocol for participants receiving simulated current is identical, but the device ceases to emit current after 30 seconds of initiation of pacing.

Sham tDCS Group

Cognitive Training BEHAVIORAL

Considering that the effects of TDCS are potentiated when applied during the execution of a task (online) (Miniussi, \& Ruzzoli, 2013), in the present study all participants received cognitive training, performed concomitantly with neurostimulation. Cognitive training consists of two parts: standardized tasks directed to social cognition and activities that stimulate executive functions. The first part consists of tasks contained in a battery of social games (Gao \& Maurer, 2009; Dillon, Kannan, Dean, Spelke, \& Duflo, 2017). While the tasks directed to the executive domain are, namely: running mazes, assembling figures, completing parts of figures and the Super Lynx Memory Game. All participants, regardless of whether they underwent active or simulated stimulation, received cognitive training, respecting the ethical principles of ensuring therapeutic assistance to those involved.

Active TDCS Group; Sham tDCS Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of ASD
• Degree of mild autistic symptomatology
• Normal or corrected acuity.

You may not qualify if:

• Intellectual deficits
• Cardiac pacemaker or implanted metallic or electronic device
• Severe neurological disorders
• Poor skull formation
• Epilepsy

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Gabriela Medeiros

João Pessoa, Paraíba, Brazil

Location

Related Publications (13)

• Amatachaya A, Auvichayapat N, Patjanasoontorn N, Suphakunpinyo C, Ngernyam N, Aree-Uea B, Keeratitanont K, Auvichayapat P. Effect of anodal transcranial direct current stimulation on autism: a randomized double-blind crossover trial. Behav Neurol. 2014;2014:173073. doi: 10.1155/2014/173073. Epub 2014 Oct 30.

  PMID: 25530675 BACKGROUND

• Amatachaya A, Jensen MP, Patjanasoontorn N, Auvichayapat N, Suphakunpinyo C, Janjarasjitt S, Ngernyam N, Aree-uea B, Auvichayapat P. The short-term effects of transcranial direct current stimulation on electroencephalography in children with autism: a randomized crossover controlled trial. Behav Neurol. 2015;2015:928631. doi: 10.1155/2015/928631. Epub 2015 Mar 12.

  PMID: 25861158 BACKGROUND

• Jamil A, Batsikadze G, Kuo HI, Labruna L, Hasan A, Paulus W, Nitsche MA. Systematic evaluation of the impact of stimulation intensity on neuroplastic after-effects induced by transcranial direct current stimulation. J Physiol. 2017 Feb 15;595(4):1273-1288. doi: 10.1113/JP272738. Epub 2016 Nov 8.

  PMID: 27723104 BACKGROUND

• Boggio PS, Asthana MK, Costa TL, Valasek CA, Osorio AA. Promoting social plasticity in developmental disorders with non-invasive brain stimulation techniques. Front Neurosci. 2015 Sep 1;9:294. doi: 10.3389/fnins.2015.00294. eCollection 2015.

  PMID: 26388712 BACKGROUND

• Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.

  PMID: 22037126 BACKGROUND

• Couture SM, Penn DL, Roberts DL. The functional significance of social cognition in schizophrenia: a review. Schizophr Bull. 2006 Oct;32 Suppl 1(Suppl 1):S44-63. doi: 10.1093/schbul/sbl029. Epub 2006 Aug 17.

  PMID: 16916889 BACKGROUND

• Demirtas-Tatlidede A, Vahabzadeh-Hagh AM, Pascual-Leone A. Can noninvasive brain stimulation enhance cognition in neuropsychiatric disorders? Neuropharmacology. 2013 Jan;64:566-78. doi: 10.1016/j.neuropharm.2012.06.020. Epub 2012 Jun 28.

  PMID: 22749945 BACKGROUND

• Dillon MR, Kannan H, Dean JT, Spelke ES, Duflo E. Cognitive science in the field: A preschool intervention durably enhances intuitive but not formal mathematics. Science. 2017 Jul 7;357(6346):47-55. doi: 10.1126/science.aal4724.

  PMID: 28684518 BACKGROUND

• Gao X, Maurer D. Influence of intensity on children's sensitivity to happy, sad, and fearful facial expressions. J Exp Child Psychol. 2009 Apr;102(4):503-21. doi: 10.1016/j.jecp.2008.11.002. Epub 2009 Jan 4.

  PMID: 19124135 BACKGROUND

• Kucharska-Pietura K, Mortimer A. Can antipsychotics improve social cognition in patients with schizophrenia? CNS Drugs. 2013 May;27(5):335-43. doi: 10.1007/s40263-013-0047-0.

  PMID: 23533009 BACKGROUND

• Kuo MF, Paulus W, Nitsche MA. Therapeutic effects of non-invasive brain stimulation with direct currents (tDCS) in neuropsychiatric diseases. Neuroimage. 2014 Jan 15;85 Pt 3:948-60. doi: 10.1016/j.neuroimage.2013.05.117. Epub 2013 Jun 4.

  PMID: 23747962 BACKGROUND

• Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.

  PMID: 20633386 BACKGROUND

• Muszkat D, Polanczyk GV, Dias TG, Brunoni AR. Transcranial Direct Current Stimulation in Child and Adolescent Psychiatry. J Child Adolesc Psychopharmacol. 2016 Sep;26(7):590-7. doi: 10.1089/cap.2015.0172. Epub 2016 Mar 30.

  PMID: 27027666 BACKGROUND

MeSH Terms

Conditions

Child Development Disorders, Pervasive; Autistic Disorder

Interventions

Transcranial Direct Current Stimulation; Cognitive Training

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Autism Spectrum Disorder

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jéssica B Santana, Master

  Federal University of Paraíba

  PRINCIPAL INVESTIGATOR

• Natanael A Santos, PhD

  Federal University of Paraíba

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants enrolled in the study using the eligibility criteria will be allocated randomly, with 1: 1 block exchange. A random number generator will be used through an online randomization program (www.random.org). Hidden allocation will be employed with numbered, opaque and sealed sequential envelopes, so that the person in charge of the allocation will not have contact with the patients, nor with the work of the others. In addition, all examiners will be blind as to the type of treatment the patient will receive (active stimulation or sham-controlled), which will be done by a specific investigator. The protocol for simulated current is identical, but the device ceases to emit current after 30 seconds of initiation of pacing. In this way, the effects of the active stimulation by short stimulation period are simulated, without inducing clinical effects. These factors characterize this trial as a double-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: this study is a sham-controlled, double-blind, randomized clinical trial aiming to evaluate the efficacy of anodic TDCS in aspects of social cognition of children between 8 and 12 years old with mild ASD. In total there will be 16 children, diagnosed with ASD according DSM-V, will be randomized to two groups, one with active stimulation (1.5 mA) and the other with a placebo current, in which the anode will be positioned over the left dorsolateral prefrontal cortex (F3), while the cathode (reference electrode) will be placed in the right supraorbital area. The intervention will be applied for 5 consecutive days for 20 minutes. Participants and investigators will be blinded. Furthermore, everyone will receive Social Cognition Training concomitantly with neurostimulation to enhance social skills in children with ASD. Patients will undergo three social cognitive assessments: at baseline, week 2 (after stimulation), and 1 month later (follow up).

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 13, 2019
• Study Start: April 30, 2018
• Primary Completion: September 30, 2018
• Study Completion: May 30, 2019
• Last Updated: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)