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Neurostimulation for Cognitive Rehabilitation in Autistic Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03947086
Recruitment Status : Active, not recruiting
First Posted : May 13, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jéssica Bruna Santana Silva, Federal University of Paraíba

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.

Condition or disease Intervention/treatment Phase
Autistic Disorders Spectrum Device: Transcranial Direct Current Stimulation (TDCS)- Active Device: Transcranial Direct Current Stimulation (TDCS)- Sham Behavioral: Cognitive Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Double (Participant, Investigator)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation for Cognitive Rehabilitation of Children With Autistic Spectrum Disorders
Actual Study Start Date : April 30, 2018
Actual Primary Completion Date : September 30, 2018
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active TDCS Group
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
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).

Behavioral: Cognitive Training

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.


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

Behavioral: Cognitive Training

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.





Primary Outcome Measures :
  1. Facial emotion recognition [ Time Frame: The test will be measured immediately before the intervention. ]

    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.

    .


  2. Facial emotion recognition [ Time Frame: The test will be measured immediately after the intervention. ]

    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.

    .


  3. Facial emotion recognition [ Time Frame: The test will be measured 4 weeks after the intervention. ]

    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.

    .


  4. Theory of mind- Verbal task [ Time Frame: The test will be measured immediately before the intervention. ]
    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.

  5. Theory of mind- Contextual task [ Time Frame: The test will be measured immediately before the intervention. ]
    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.

  6. Theory of mind- Verbal task [ Time Frame: The test will be measured immediately after the intervention. ]
    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.

  7. Theory of mind- Contextual task [ Time Frame: The test will be measured immediately after the intervention. ]
    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.

  8. Theory of mind- Verbal task [ Time Frame: The test will be measured 4 weeks after the intervention. ]
    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.

  9. Theory of mind- Contextual task [ Time Frame: The test will be measured 4 weeks after the intervention. ]
    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.


Secondary Outcome Measures :
  1. Memory for Digit Span [ Time Frame: The test will be measured immediately before the intervention. ]
    The measure was used to evaluate the operational memory. There are two parts to the Memory for Digit Span assessment: Digits Forward and Digits Backward. Each tap distinct but interdependent cognitive functions. Digits Forward primarily taps short-term auditory memory while Digits Backward measures the child's ability to manipulate verbal information while in temporary storage. In Digits Forward, the child listens to and repeats a sequence of numbers spoken aloud by the interviewer. In Digits Backward, the child listens to a sequence of numbers and repeats them in reverse order.

  2. Memory for Digit Span [ Time Frame: The test will be measured immediately after the intervention. ]
    The measure was used to evaluate the operational memory. There are two parts to the Memory for Digit Span assessment: Digits Forward and Digits Backward. Each tap distinct but interdependent cognitive functions. Digits Forward primarily taps short-term auditory memory while Digits Backward measures the child's ability to manipulate verbal information while in temporary storage. In Digits Forward, the child listens to and repeats a sequence of numbers spoken aloud by the interviewer. In Digits Backward, the child listens to a sequence of numbers and repeats them in reverse order.

  3. Memory for Digit Span [ Time Frame: The test will be measured 4 weeks after the intervention. ]
    The measure was used to evaluate the operational memory. There are two parts to the Memory for Digit Span assessment: Digits Forward and Digits Backward. Each tap distinct but interdependent cognitive functions. Digits Forward primarily taps short-term auditory memory while Digits Backward measures the child's ability to manipulate verbal information while in temporary storage. In Digits Forward, the child listens to and repeats a sequence of numbers spoken aloud by the interviewer. In Digits Backward, the child listens to a sequence of numbers and repeats them in reverse order.

  4. Trail Making Test A e B [ Time Frame: The test will be measured immediately before the intervention. ]
    The TMT measures attention, speed, and mental flexibility. Part A requires the individual to draw lines to connect 25 encircled numbers distributed on a page. Part A tests visual scanning, numeric sequencing, and visuomotor speed. Part B is similar except the person must alternate between numbers and letters and is believed to be more difficult and takes longer to complete. Part B tests cognitive demands including visual motor and visual spatial abilities and mental flexibility.

  5. Trail Making Test A e B [ Time Frame: The test will be measured immediately after the intervention. ]
    The TMT measures attention, speed, and mental flexibility. Part A requires the individual to draw lines to connect 25 encircled numbers distributed on a page. Part A tests visual scanning, numeric sequencing, and visuomotor speed. Part B is similar except the person must alternate between numbers and letters and is believed to be more difficult and takes longer to complete. Part B tests cognitive demands including visual motor and visual spatial abilities and mental flexibility.

  6. Trail Making Test A e B [ Time Frame: The test will be measured 4 weeks after the intervention. ]
    The TMT measures attention, speed, and mental flexibility. Part A requires the individual to draw lines to connect 25 encircled numbers distributed on a page. Part A tests visual scanning, numeric sequencing, and visuomotor speed. Part B is similar except the person must alternate between numbers and letters and is believed to be more difficult and takes longer to complete. Part B tests cognitive demands including visual motor and visual spatial abilities and mental flexibility.

  7. Seven Errors Test [ Time Frame: The test will be measured immediately before the intervention. ]
    This test aims to evaluate executive functions globally. The test consists of two different pairs of figures: a pair of figures of one elephant, and another pair refers to a boat. Each pair has the original figure and the figure containing the errors, both appear simultaneously on the screen, side by side, and the participant must identify the errors / differences between the figures. The 300 Hz binocular Eye Tracker Tobii was used to monitor eye movements during the test.

  8. Seven Errors Test [ Time Frame: The test will be measured immediately after the intervention. ]
    This test aims to evaluate executive functions globally. The test consists of two different pairs of figures: a pair of figures of one elephant, and another pair refers to a boat. Each pair has the original figure and the figure containing the errors, both appear simultaneously on the screen, side by side, and the participant must identify the errors / differences between the figures. The 300 Hz binocular Eye Tracker Tobii was used to monitor eye movements during the test.

  9. Seven Errors Test [ Time Frame: The test will be measured 4 weeks after the intervention. ]
    This test aims to evaluate executive functions globally. The test consists of two different pairs of figures: a pair of figures of one elephant, and another pair refers to a boat. Each pair has the original figure and the figure containing the errors, both appear simultaneously on the screen, side by side, and the participant must identify the errors / differences between the figures. The 300 Hz binocular Eye Tracker Tobii was used to monitor eye movements during the test.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947086


Locations
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Brazil
Gabriela Medeiros
João Pessoa, Paraíba, Brazil
Sponsors and Collaborators
Federal University of Paraíba
Investigators
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Principal Investigator: Jéssica B Santana, Master Federal University of Paraíba
Study Director: Natanael A Santos, PhD Federal University of Paraíba

Publications:

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Responsible Party: Jéssica Bruna Santana Silva, Principal Investigator, Federal University of Paraíba
ClinicalTrials.gov Identifier: NCT03947086    
Other Study ID Numbers: U1111-1221-6178
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jéssica Bruna Santana Silva, Federal University of Paraíba:
Autistic disorder
Neuromodulation
Social cognition
Executive functions
Eye tracking
Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders