Autism Spectrum DisorderNCT05371912
Enhancement of Behavioral and Cognitive Outcomes in Autism Spectrum Disorder Via Neurostimulation
A study testing Trans Cranial Magnetic Stimulation in people with Autism Spectrum Disorder, run by Christiana Care Health Services at 1 site in United States.
Trial summary
Autism spectrum disorder (ASD) encompasses a range of limitations in reciprocal social and communicative milestones, as well as restrictive and/or repetitive patterns of behavior which lead to significant functional challenges impacting individuals throughout their lifespan. Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Trans Cranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 1 Feb 2024
- 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 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Fulfilling the Diagnostic and Statistical Manual for Mental Disorders 5th edition (DSM-V) criteria for ASD and confirmed by Gilliam Asperger Disorder Scale (GADS)
- The patient exhibiting adequate understanding and cooperation for the procedure
Who cannot join
- Patients with ASD exhibiting significant anxiety or contact avoidance, precluding them from cooperating with the procedure
- Children with a known diagnosis of seizures
- Presence of any metallic implants or devices in the head or neck area
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Autism spectrum disorder (ASD) encompasses a range of limitations in reciprocal social and communicative milestones, as well as restrictive and/or repetitive patterns of behavior which lead to significant functional challenges impacting individuals throughout their lifespan. There are major shortcomings in the existing pharmacological interventions; they are of limited efficacy, target a subset of problematic behaviors, and fail to improve social cognition. To overcome these limitations and improve outcomes, the investigators study the use of neurostimulation to mitigate the social and cognitive manifestations of ASD.
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neurostimulation technique that alters cortical excitability by repeated induction of electromagnetic activity. FDA approved for depression, rTMS is a promising tool in the field of neuropsychiatry with an excellent safety profile. A prevailing hypothesis in ASD proposes that mirror neuron dysfunction in the inferior parietal lobule (IPL) contributes to the core deficits. The left and right IPL regions support different social and cognitive functions and moreover, are differentially impacted in ASD. Therefore, it can be expected that enhancing function of the IPL may produce positive but hemispheric-dependent effects on social cognition. The investigators long-term goal in this pilot proposal is to understand whether stimulating IPL with rTMS improves social and cognitive outcomes in ASD.
This research, which builds upon our proof-of-concept testing of 4 patients, proposes 10 sessions of rTMS stimulation of the IPL. Participants will be randomized to receive active stimulation to either the left or right-IPL (with sham stimulation to the contralateral side) in a prospective, double-blind protocol during which neither the subject nor the neuropsychologist obtaining and interpreting the outcome measures will have awareness of the rTMS group. For targeting the IPL, which correlates with the Brodmann areas 40/7 on the cortex, the investigators use disposable mapping caps, and for the purpose of blinding, the investigators use a standard shamming technique. Outcome measures include neuropsychological testing administered at baseline, after completion of TMS regime, and three months later. Within this design, the investigators have three aims:
Aim 1: Assess the differential effects of rTMS of the left versus right IPL on linguistic abilities and executive function in ASD. Hypothesis: rTMS stimulation of the IPL leads to long term potentiation and hence enhances cognitive performance in a hemispheric dependent manner with left-IPL stimulation enhancing linguistic ability and right-IPL stimulation enhancing executive function. To measure the effects, the investigators will use the Delis-Kaplan Executive Function System Verbal Fluency task (D-KEFS) and two elements of the NIH toolbox: Flanker: a test to measure the inhibitory and attentional facets of Executive Functioning. Dimensional Change Card Sort (DCCS): a task designed to assess cognitive flexibility. The investigators expect improvement in the Flanker and DCCS scores with right IPL stimulation and D-KEFS score improvement with left IPL stimulation.
Aim 2: Determine the effects of unilateral rTMS of the IPL on social/behavioral deficits in children and young adults with ASD. Hypothesis: rTMS simulation of the mirror neuron system potentiates similar improvements in social cognition despite hemispheric laterality via separate but related mechanisms. To measure the outcomes of right v/s left unilateral IPL stimulation, the investigators will use two standard scales and compare the numerical values before and after the intervention. The Social Responsiveness Scale - 2nd Edition (SRS2) and the Repetitive Behavior Scale-Revised (RRBs) are validated parent/caregiver-rated scale of social/communication deficits and restricted/repetitive behaviors respectively.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Trans Cranial Magnetic Stimulation
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans Cranial Magnetic StimulationDevice
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neurostimulation technique that alters cortical excitability by repeated induction of electromagnetic activity. FDA approved for depression, rTMS is a promising tool in the field of neuropsychiatry with an excellent safety profile.
| Study group | Role | What they receive |
|---|---|---|
| left IPL stimulation | Active comparator | half of the subjects will receive TMS on the left inferior parietal lobule. Receives: Device: Trans Cranial Magnetic Stimulation |
| right IPL stimulation | Active comparator | half of the subjects will receive TMS on the right inferior parietal lobule. Receives: Device: Trans Cranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effects of rTMS on Reciprocal Social Awareness
Social Responsiveness Scale, Second Edition (SRS-2), Parent/Caregiver form; 65 items scored 0-3; total raw score range 0-195. Higher scores = greater social impairment. This study reports raw totals (not T-scores). Instrument: SRS-2
Measured: at baseline and 5 weeks of rTMS
The Effects of rTMS on Reciprocal Rigid Patterns of Behavior
Repetitive Behavior Scale-Revised (RBS-R); 43 items scored 0-3; total raw score range 0-129. Higher scores = more severe restricted/repetitive behaviors. We report total raw scores.
Measured: at baseline and 5 weeks of rTMS
Secondary outcomes (3)
The Effect of rTMS on Verbal Fluency
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency; scores converted to age-normed scaled scores (mean 10, SD 3). Higher scores = better verbal fluency/executive function. We report the Total Correct scaled score per the manual.
Measured: at baseline and 5 weeks of rTMS
The Effects of rTMS on Executive Function Using Flanker Task
NIH Toolbox Flanker Inhibitory Control and Attention; Age-Adjusted Standard Scores (mean 100, SD 15) reported. Higher scores = better inhibitory control/attention.
Measured: at baseline and 5 weeks of rTMS
The Effects of rTMS on Executive Function
NIH Toolbox Dimensional Change Card Sort (DCCS); Age-Adjusted Standard Scores (mean 100, SD 15) reported. Higher scores = better cognitive flexibility.
Measured: at baseline and 5 weeks of rTMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start15 Mar 2022
- Primary completion31 Oct 2023
- Study completion1 Feb 2024
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 Autism Spectrum DisorderStudies 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
- Model description
- The patients will be randomized at the time of recruitment to either receiving left or right IPL stimulation. A shamming technique will be applied to the opposite hemisphere. Both the patient and the neuropsychologist obtaining and interpreting the outcome measures will be blinded regarding the hemispheric side of rTMS intervention. Only the clinician delivering the rTMS treatment will have a knowledge about the treatment targeting.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Dupont Applied Biosciences
- Responsible party
- Principal investigator, Mitra Assadi, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371912
- Sponsor's protocol ID
- DDD 604994
- Status last verified
- Nov 2025
- First submitted
- 1 May 2022
- Last updated
- 26 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Behavioral and Cognitive Outcomes in Autism Spectrum Disorder Via Neurostimulation
- ClinicalTrials.gov ID
- NCT05371912
- Acronym / sponsor ID
- DDD 604994
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- Dupont Applied Biosciences
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Posted 26 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autism spectrum disorder (ASD) encompasses a range of limitations in reciprocal social and communicative milestones, as well as restrictive and/or repetitive patterns of behavior which lead to significant functional challenges impacting individuals throughout their lifespan. There are major shortcomings in the existing pharmacological interventions; they are of limited efficacy, target a subset of problematic behaviors, and fail to improve social cognition. To overcome these limitations and improve outcomes, the investigators study the use of neurostimulation to mitigate the social and cognitive manifestations of ASD.
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neurostimulation technique that alters cortical excitability by repeated induction of electromagnetic activity. FDA approved for depression, rTMS is a promising tool in the field of neuropsychiatry with an excellent safety profile. A prevailing hypothesis in ASD proposes that mirror neuron dysfunction in the inferior parietal lobule (IPL) contributes to the core deficits. The left and right IPL regions support different social and cognitive functions and moreover, are differentially impacted in ASD. Therefore, it can be expected that enhancing function of the IPL may produce positive but hemispheric-dependent effects on social cognition. The investigators long-term goal in this pilot proposal is to understand whether stimulating IPL with rTMS improves social and cognitive outcomes in ASD.
This research, which builds upon our proof-of-concept testing of 4 patients, proposes 10 sessions of rTMS stimulation of the IPL. Participants will be randomized to receive active stimulation to either the left or right-IPL (with sham stimulation to the contralateral side) in a prospective, double-blind protocol during which neither the subject nor the neuropsychologist obtaining and interpreting the outcome measures will have awareness of the rTMS group. For targeting the IPL, which correlates with the Brodmann areas 40/7 on the cortex, the investigators use disposable mapping caps, and for the purpose of blinding, the investigators use a standard shamming technique. Outcome measures include neuropsychological testing administered at baseline, after completion of TMS regime, and three months later. Within this design, the investigators have three aims:
Aim 1: Assess the differential effects of rTMS of the left versus right IPL on linguistic abilities and executive function in ASD. Hypothesis: rTMS stimulation of the IPL leads to long term potentiation and hence enhances cognitive performance in a hemispheric dependent manner with left-IPL stimulation enhancing linguistic ability and right-IPL stimulation enhancing executive function. To measure the effects, the investigators will use the Delis-Kaplan Executive Function System Verbal Fluency task (D-KEFS) and two elements of the NIH toolbox: Flanker: a test to measure the inhibitory and attentional facets of Executive Functioning. Dimensional Change Card Sort (DCCS): a task designed to assess cognitive flexibility. The investigators expect improvement in the Flanker and DCCS scores with right IPL stimulation and D-KEFS score improvement with left IPL stimulation.
Aim 2: Determine the effects of unilateral rTMS of the IPL on social/behavioral deficits in children and young adults with ASD. Hypothesis: rTMS simulation of the mirror neuron system potentiates similar improvements in social cognition despite hemispheric laterality via separate but related mechanisms. To measure the outcomes of right v/s left unilateral IPL stimulation, the investigators will use two standard scales and compare the numerical values before and after the intervention. The Social Responsiveness Scale - 2nd Edition (SRS2) and the Repetitive Behavior Scale-Revised (RRBs) are validated parent/caregiver-rated scale of social/communication deficits and restricted/repetitive behaviors respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients will be randomized at the time of recruitment to either receiving left or right IPL stimulation. A shamming technique will be applied to the opposite hemisphere. Both the patient and the neuropsychologist obtaining and interpreting the outcome measures will be blinded regarding the hemispheric side of rTMS intervention. Only the clinician delivering the rTMS treatment will have a knowledge about the treatment targeting.
| Arm | Type | Receives |
|---|---|---|
| left IPL stimulation | Active comparator | Device: Trans Cranial Magnetic Stimulationhalf of the subjects will receive TMS on the left inferior parietal lobule. |
| right IPL stimulation | Active comparator | Device: Trans Cranial Magnetic Stimulationhalf of the subjects will receive TMS on the right inferior parietal lobule. |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Fulfilling the Diagnostic and Statistical Manual for Mental Disorders 5th edition (DSM-V) criteria for ASD and confirmed by Gilliam Asperger Disorder Scale (GADS)
- The patient exhibiting adequate understanding and cooperation for the procedure
Key exclusion criteria (4 listed)
- Patients with ASD exhibiting significant anxiety or contact avoidance, precluding them from cooperating with the procedure
- Children with a known diagnosis of seizures
- Presence of any metallic implants or devices in the head or neck area
- Pregnant women
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 |
|---|---|---|
| Trans Cranial Magnetic StimulationRepetitive transcranial magnetic stimulation (rTMS) is a non-invasive neurostimulation technique that alters cortical excitability by repeated induction of electromagnetic activity. FDA approved for depression, rTMS is a promising tool in the field of neuropsychiatry with an excellent safety profile. | Device | left IPL stimulation, right IPL stimulation |
Primary outcome
The Effects of rTMS on Reciprocal Social Awareness
Time frame: at baseline and 5 weeks of rTMS
Social Responsiveness Scale, Second Edition (SRS-2), Parent/Caregiver form; 65 items scored 0-3; total raw score range 0-195. Higher scores = greater social impairment. This study reports raw totals (not T-scores). Instrument: SRS-2
The Effects of rTMS on Reciprocal Rigid Patterns of Behavior
Time frame: at baseline and 5 weeks of rTMS
Repetitive Behavior Scale-Revised (RBS-R); 43 items scored 0-3; total raw score range 0-129. Higher scores = more severe restricted/repetitive behaviors. We report total raw scores.
3 secondary outcomes
The Effect of rTMS on Verbal Fluency
Time frame: at baseline and 5 weeks of rTMS
The Effects of rTMS on Executive Function Using Flanker Task
Time frame: at baseline and 5 weeks of rTMS
The Effects of rTMS on Executive Function
Time frame: at baseline and 5 weeks of rTMS
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans Cranial Magnetic Stimulation in people with Autism Spectrum Disorder, run by Christiana Care Health Services 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 2 inclusion and 4 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 26 Nov 2025. 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. 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 26 Nov 2025). 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?
The Effects of rTMS on Reciprocal Social Awareness (time frame: at baseline and 5 weeks of rTMS). 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 26 Nov 2025.