AutismLENSNCT02998684
Learning Enhancement Through Neurostimulation in Autism
A study testing Active Transcranial Direct Current Stimulation and PEERS Social Skills Training in people with Autism, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study will examine whether brain stimulation paired with social skills learning can help teenage boys with autism learn how to make and keep friends. Brain stimulation can enhance learning in some people. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- Active Transcranial Direct Current Stimulation and PEERS Social Skills Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Autism Spectrum Disorder
Who cannot join
- Intellectual Disabilities (Full-scale IQ <70)
- Hx of seizures within the last one year
- Contraindications for fMRI, such as metal implants in the head
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Univeristy of South Carolina
Charleston, South Carolina, 29425
About this study
This study will examine whether brain stimulation paired with social skills learning can help teenage boys with autism learn how to make and keep friends. Brain stimulation can enhance learning in some people. This study involves enrolling in a 14-week training program where teenage boys with autism interact in small groups and learn social skills. During the 14-week program participants will receive active brain stimulation, or non-active stimulation (placebo). Before and after this training, MRI scans will be taken to see whether the training with active brain stimulation made a different in brain activation.
- Conditions
- Autism
- Being tested
- Active Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation, PEERS Social Skills Training
- Keywords
- Autism, Adolescent, Social skills
- Medical subject headings
- Autistic Disorder, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial Direct Current StimulationDevice
Sham Transcranial Direct Current StimulationDevice
PEERS Social Skills TrainingBehavioural
14 weekly social skills training sessions for all participants
| Study group | Role | What they receive |
|---|---|---|
| Active Transcranial Direct Current Stimulation | Active comparator | Participants will receive active Transcranial Direct Current Stimulation Receives: Device: Active Transcranial Direct Current Stimulation; Behavioral: PEERS Social Skills Training |
| Sham Transcranial Direct Current Stimulation | Sham comparator | Participants will receive sham Transcranial Direct Current Stimulation Receives: Device: Sham Transcranial Direct Current Stimulation; Behavioral: PEERS Social Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Adolescent Social Skills Knowledge (TASSK)
Change in TASSK raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Post minus pre-treatment: positive scores indicate improvement). Assessment scores can range from 0 to 26, 0 being the lowest possible score and 26 being the highest.
Measured: Baseline to 14-weeks
Social Responsiveness Scale (SRS)
Change in SRS raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Pre minus post-treatment: positive scores indicate improvement). Raw scores range from 0 to 195, with higher scores indicating greater severity of symptoms.
Measured: Baseline to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Jane Joseph, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998684
- Sponsor's protocol ID
- Pro00056912
- Acronym
- LENS
- Status last verified
- Aug 2018
- First submitted
- 1 Dec 2016
- Last updated
- 4 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Enhancement Through Neurostimulation in Autism
- ClinicalTrials.gov ID
- NCT02998684
- Acronym / sponsor ID
- LENS / Pro00056912
- Conditions
- Autism
- Keywords
- Autism, Adolescent, Social skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Posted 4 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine whether brain stimulation paired with social skills learning can help teenage boys with autism learn how to make and keep friends. Brain stimulation can enhance learning in some people. This study involves enrolling in a 14-week training program where teenage boys with autism interact in small groups and learn social skills. During the 14-week program participants will receive active brain stimulation, or non-active stimulation (placebo). Before and after this training, MRI scans will be taken to see whether the training with active brain stimulation made a different in brain activation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Transcranial Direct Current Stimulation | Active comparator | Device: Active Transcranial Direct Current Stimulation, Behavioral: PEERS Social Skills TrainingParticipants will receive active Transcranial Direct Current Stimulation |
| Sham Transcranial Direct Current Stimulation | Sham comparator | Device: Sham Transcranial Direct Current Stimulation, Behavioral: PEERS Social Skills TrainingParticipants will receive sham Transcranial Direct Current Stimulation |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Autism Spectrum Disorder
Key exclusion criteria (3 listed)
- Intellectual Disabilities (Full-scale IQ <70)
- Hx of seizures within the last one year
- Contraindications for fMRI, such as metal implants in the head
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Transcranial Direct Current Stimulation | Device | Active Transcranial Direct Current Stimulation |
| Sham Transcranial Direct Current Stimulation | Device | Sham Transcranial Direct Current Stimulation |
| PEERS Social Skills Training14 weekly social skills training sessions for all participants | Behavioural | Active Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation |
Primary outcome
Test of Adolescent Social Skills Knowledge (TASSK)
Time frame: Baseline to 14-weeks
Change in TASSK raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Post minus pre-treatment: positive scores indicate improvement). Assessment scores can range from 0 to 26, 0 being the lowest possible score and 26 being the highest.
Social Responsiveness Scale (SRS)
Time frame: Baseline to 14 weeks
Change in SRS raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Pre minus post-treatment: positive scores indicate improvement). Raw scores range from 0 to 195, with higher scores indicating greater severity of symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Joseph, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcranial Direct Current Stimulation and PEERS Social Skills Training in people with Autism, run by Medical University of South Carolina at 1 site in United States.
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 1 inclusion and 3 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 4 Sep 2018. 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 States. 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?
Yes. Results are posted in the registry (first posted 4 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Test of Adolescent Social Skills Knowledge (TASSK) (time frame: Baseline to 14-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2018.