Ignite Creation Date:
2024-05-06 @ 2:52 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04446442
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2019-11-12
Brief Title:
Cerebellar tDCS in Children With Autism Spectrum Disorder
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Biologic Effects and Efficacy of Cerebellar tDCS in Children With Autism Spectrum Disorder
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to investigate whether tDCS to the cerebellum specifically the right crus III area of the cerebellum of children and young adults with autism spectrum disorders ASD is safe and to examine its effects on some of the symptoms of ASD such as repetitive behaviors and hyperactivity
Detailed Description:
The study will be randomized double-blind and controlled It will involve a group of 60 children with ASD diagnosed with the Autism Diagnostic Observation Schedule ADOS-2 by a research-reliable clinician coming in for an orientation day where participants will be acclimated to the testing environment as well as undergo safety screening and a mock MRI The investigators will recruit from a sample of children diagnosed with ASD The diagnosis must be made by experienced research reliable clinicians using gold standard measures including the Autism Diagnostic Observation schedule Second Edition Study or ADOS-2 and a diagnostic and developmental parent interview The investigators will request this information from the institution where the diagnosis was given with parentcaregiver permission Diagnostic information will be reviewed by the study neuropsychologist and if additional testing is needed to update or confirm the diagnosis the investigators will administer an ADOS-2 here at UTSW prior to other baseline measures If diagnostic information from a previous CADD clinic visit or an outside institution by a research reliable clinician is current the investigators will accept it
Participants will complete in a variety of tasks during a pre-treatment visit In addition baseline behavioral measurements will be performed These tests include an abbreviated measure of cognitive ability using the Stanford Binet-Fifth Edition interpretation of facial expressions memory for faces reading the mind in the eyes triangle animations cyberball social ball throwing dimensional card change sort and caregiver-completed behavioral scale including the Autsim Spectrum Rating Scale ASRS Participants will also be asked about their mood before during and after treatment Participants will then be randomly assigned into either a sham treatment group or an active treatment group The next time the participants come in participants vitals will be monitored in addition to eye monitoring and will undergo either 1 mA for 20 minutes of anodal or cathodal tDCS administration to Right Crus III area of the cerebellum or sham treatment Participants will undergo fMRI imaging prior during and after anodal or cathodal tDCS After the scans testing will be repeated and include interpretation of facial expression memory for faces reading the mind in the eyes triangle animations theory of mind cyberballsocial ball throwing and dimensional card change sort At the end of the visit parentsguardiansparticipants will receive a safety questionnaire asking about the presence and severity of the possible side effects The participants will then follow up in 1 week with the safety questionnaire and at 1 month with the safety questionnaire and the Autism Spectrum Rating Scale
Study Procedures
Investigators including those involved in questionnaire and behavioral scales administration and fMRI scanninginterpreting will be blinded to which treatment group participants are in Staff members in charge of applying tDCS will be aware of what treatment group the participant is in but will not be involved in analysis of data to ensure blinding of results As far as the tDCS procedure goes the device consists of a programmable current source with a rechargeable battery with two wires connected to electrodes in fabric pads The device cannot be plugged into an outlet while the electrodes are connected ensuring safety tDCS pads are moistened with 09 normal saline and placed on the participants scalp using elastic bands During stimulation the electrodes will apply 1 mA of constant DC electrical current Current will be increased over 10-60 seconds The current will be applied for no more than 20 minutes after which the current is decreased over 10-60 seconds In sham tDCS the current is increased and then immediately decreased to provide sensations associated with tDCS mild tingling or itching which blinds the participant
Testing will take place before on orientation day and after tDCS Baseline testing includes an ADOS-2 if deemed necessary an abbreviated cognitive measure interpretation of facial expressions memory for faces reading the mind in the eyes triangle animations cyberball social ball throwing dimensional card change sort and caregiver-completed behavioral scale including the Autsim Spectrum Rating Scale Testing immediately after tDCS includes only the following interpretation of facial expressions memory for faces reading the mind in the eyes triangle animations theory of mind cyberballsocial ball throwing and dimensional card change sort
Participants with ASD will come in on designated orientation days and be assigned an alphanumeric identifier to ensure confidentiality An initial safety screening will be done to ensure no exclusion criteria are met Participants will then be randomly split into either a sham group or a treatment group Baseline testing will be completed Participants will then be allowed to explore and become acclimated with study equipment and a mock MRI will be done on the first visit at the UTSW Advanced Imaging Research Center AIRC
Participants will be desensitized to the sounds and tactile sensations of the fMRI environment while in a space similar to that of the scanner bore Participants will practice remaining still within the mock MRI while viewing a movie and biofeedback is used to train participants to keep their movement 1mm during practice periods of 10 minutes Participants should be able to complete all of the screening in one visit If participants cannot due to time constraints participants will be brought back in on a different day to complete the screening visit
The next time participants return participants will be hooked up to vitals and eye movement monitoring and will be placed in the fMRI machine so the before scanning can begin After this before scan tDCS electrodes will be applied and participants will again be placed in the fMRI machine for the during scan As soon as scanning begins tDCS either sham or treatment of 1 mA for 20 minutes of anodal tDCS administration to the Right Crus III area of the cerebellum will begin as well During tDCS treatment caregivers will receive a safety questionnaire for them to assess any side effects occurring in their child After this scan the tDCS electrode will be removed and a final after fMRI scan will take place The safety questionnaire will be given after tDCS at the end of the visit and behavioral tests are completeThe time estimated for all of this is about 90-180 minutes
The Safety Questionnaire will be assessed again with follow-up visits 1 week and 1 month afterwards using the same caregiver-completed scales
Participants will complete in a variety of tasks during a pre-treatment visit In addition baseline behavioral measurements will be performed These tests include an abbreviated measure of cognitive ability using the Stanford Binet-Fifth Edition interpretation of facial expressions memory for faces reading the mind in the eyes triangle animations cyberball social ball throwing dimensional card change sort and caregiver-completed behavioral scale including the Autsim Spectrum Rating Scale ASRS Participants will also be asked about their mood before during and after treatment Participants will then be randomly assigned into either a sham treatment group or an active treatment group The next time the participants come in participants vitals will be monitored in addition to eye monitoring and will undergo either 1 mA for 20 minutes of anodal or cathodal tDCS administration to Right Crus III area of the cerebellum or sham treatment Participants will undergo fMRI imaging prior during and after anodal or cathodal tDCS After the scans testing will be repeated and include interpretation of facial expression memory for faces reading the mind in the eyes triangle animations theory of mind cyberballsocial ball throwing and dimensional card change sort At the end of the visit parentsguardiansparticipants will receive a safety questionnaire asking about the presence and severity of the possible side effects The participants will then follow up in 1 week with the safety questionnaire and at 1 month with the safety questionnaire and the Autism Spectrum Rating Scale
Study Procedures
Investigators including those involved in questionnaire and behavioral scales administration and fMRI scanninginterpreting will be blinded to which treatment group participants are in Staff members in charge of applying tDCS will be aware of what treatment group the participant is in but will not be involved in analysis of data to ensure blinding of results As far as the tDCS procedure goes the device consists of a programmable current source with a rechargeable battery with two wires connected to electrodes in fabric pads The device cannot be plugged into an outlet while the electrodes are connected ensuring safety tDCS pads are moistened with 09 normal saline and placed on the participants scalp using elastic bands During stimulation the electrodes will apply 1 mA of constant DC electrical current Current will be increased over 10-60 seconds The current will be applied for no more than 20 minutes after which the current is decreased over 10-60 seconds In sham tDCS the current is increased and then immediately decreased to provide sensations associated with tDCS mild tingling or itching which blinds the participant
Testing will take place before on orientation day and after tDCS Baseline testing includes an ADOS-2 if deemed necessary an abbreviated cognitive measure interpretation of facial expressions memory for faces reading the mind in the eyes triangle animations cyberball social ball throwing dimensional card change sort and caregiver-completed behavioral scale including the Autsim Spectrum Rating Scale Testing immediately after tDCS includes only the following interpretation of facial expressions memory for faces reading the mind in the eyes triangle animations theory of mind cyberballsocial ball throwing and dimensional card change sort
Participants with ASD will come in on designated orientation days and be assigned an alphanumeric identifier to ensure confidentiality An initial safety screening will be done to ensure no exclusion criteria are met Participants will then be randomly split into either a sham group or a treatment group Baseline testing will be completed Participants will then be allowed to explore and become acclimated with study equipment and a mock MRI will be done on the first visit at the UTSW Advanced Imaging Research Center AIRC
Participants will be desensitized to the sounds and tactile sensations of the fMRI environment while in a space similar to that of the scanner bore Participants will practice remaining still within the mock MRI while viewing a movie and biofeedback is used to train participants to keep their movement 1mm during practice periods of 10 minutes Participants should be able to complete all of the screening in one visit If participants cannot due to time constraints participants will be brought back in on a different day to complete the screening visit
The next time participants return participants will be hooked up to vitals and eye movement monitoring and will be placed in the fMRI machine so the before scanning can begin After this before scan tDCS electrodes will be applied and participants will again be placed in the fMRI machine for the during scan As soon as scanning begins tDCS either sham or treatment of 1 mA for 20 minutes of anodal tDCS administration to the Right Crus III area of the cerebellum will begin as well During tDCS treatment caregivers will receive a safety questionnaire for them to assess any side effects occurring in their child After this scan the tDCS electrode will be removed and a final after fMRI scan will take place The safety questionnaire will be given after tDCS at the end of the visit and behavioral tests are completeThe time estimated for all of this is about 90-180 minutes
The Safety Questionnaire will be assessed again with follow-up visits 1 week and 1 month afterwards using the same caregiver-completed scales
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None