Autism Spectrum DisorderNCT06255535
pBFS Guided rTMS Over Cognitive Control Network for ASD
A study testing active iTBS treatment in people with Autism Spectrum Disorder, run by Changping Laboratory at 6 sites in China.
Trial summary
The aim of this trial is to assess the efficacy and safety of precision neuromodulation for alleviating core symptoms in patients with autism spectrum disorder (ASD) who also have intellectual or developmental delay. Read more about this study
- Who is it for?
- Ages 6 to 30 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- active iTBS treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- 6 sitesChina
- Study dates
- 1 Apr 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 6-30 years old
- Have the diagnosis of autism spectrum disorder
- ADOS-2 score is higher than the ASD cut-offs
- Comorbid with intelligent disorder, IQ/DQ < 70
- Primary environmental language is Chinese
- Participant's parents or other legal guardians give informed consent
Who cannot join
- Genetic Disorders, such as (e.g., Down syndrome, Fragile X syndrome, Rett syndorme), Current or history of severe ADHD, tourette syndrome, psychotic disorders (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
- Severe self-injury or suicidal behavior exhibited within the past year
- Significant visual, auditory, deafness or motor disability that prevent them from following study procedures
- Current or history diagnosis of epilepsy
- Known severe physical diseases, particularly those affecting the brain
- Metal implantation contradicted by MRI or TMS, such as artificial cardiac pacemakers, stents, cochlear implants
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- Respiratory or circulatory conditions increasing sedation risk, such as Apnea syndrome, severe snoring, or other relevant diseases
- All legal guardians are illiterate, unable to read informed documents or complete questionnaires independently
- Received transcranial magnetic stimulation (TMS), transcranial current stimulation (tCS), focused ultrasound (FUS), or other neuromodulation treatment in the last 3 months
- Current participation in other clinical trials
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Hebei Provincial Mental Health Center
Baoding, Hebei
- Recruiting
Fujian Children's Hospital
Fuzhou, Fujian
- Recruiting
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian
- Recruiting
Jining Medical University
Jining, Shandong
- Recruiting
Linyi Hedong Rehabilitation Hospital
Linyi, Shandong
- Recruiting
Xi'an TCM Hospital of Encephalopathy
Xi'an, Shaanxi
Feng Gao
About this study
Official title: Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Low-Functioning Autism Spectrum Disorder: a Multi-center, Randomized, Sham-controlled Trial
The aim of this trial is to assess the efficacy and safety of precision neuromodulation for alleviating core symptoms in patients with autism spectrum disorder (ASD) who also have intellectual or developmental delay. The neuromodulation will be administered using intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC), guided by personalized Brain Functional Sector (pBFS) technology.
Read the detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by impaired social communication and repetitive behaviors. Unfortunately, evidence-based treatments have not proven effective for older individuals with low-functioning ASD, despite their significant need for intensive support. However, emerging evidence suggests that Transcranial Magnetic Stimulation (TMS) has been successful in treating various psychiatric and neurological disorders.
Given the broad cognitive control dysfunction observed in ASD, targeting cognitive control function may offer a promising treatment approach. Leveraging the personalized Brain Functional Sector (pBFS) technique and task-free functional MRI scans, we can precisely locate the cognitive control function region within the left DLPFC, and follow-up at 24-week after initiation of treatment.
In this study, participants who meet the inclusion and exclusion criteria will be randomly assigned to either active or sham iTBS (intermittent theta burst stimulation) groups at a ratio of 2:1. The treatment protocol consists of a 12-week duration, with sessions conducted 5 days per week and 3 sessions iTBS over DLPFC per day. The inter-session interval is set at 30 minutes. Clinical evaluations focusing on ASD core symptoms and related behavioral profiles will be conducted at baseline and after the 12-week treatment period.
- Conditions
- Autism Spectrum Disorder
- Being tested
- active iTBS treatment, sham iTBS treatment
- Keywords
- intellectual or development delay, personalized, TMS, functional MRI
- Medical subject headings
- Autism Spectrum Disorder, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active iTBS treatmentDevice
Participants will undergo three iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Individualized targets will be generated using the pBFS technique.
sham iTBS treatmentDevice
Participants will undergo three iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Sham stimulation will be delivered through a sham coil with the identical appearance as real coil. Individualized targets will be generated using the pBFS technique.
| Study group | Role | What they receive |
|---|---|---|
| active iTBS group | Experimental | active iTBS over DLPFC Receives: Device: active iTBS treatment |
| Sham group | Sham comparator | sham iTBS over DLPFC Receives: Device: sham iTBS treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADOS-2 SA CSS score change after treatment
The score changes of ADOS-2 SA CSS (Autism Diagnostic Observation Scale, 2nd edition, social affect domain, calibrated severity score) at 12-week from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), post-treatment (12-week)
Secondary outcomes (8)
ADOS-2 SA CSS score change from baseline to follow-up
The score changes of ADOS-2 SA CSS from baseline, to 12-week posttreatment and, to 24-week follow-up. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
Response rate in social ability after 12-week iTBS treatment
Treatment response is defined as improvement, i.e., at least 1-point decreased, in the ADOS-2 SA For ADOS-2 SA, higher scores means more severe symptom.
Measured: Pre-treatment (baseline), post-treatment (12-week)
Response rate in social ability at 24-week follow-up
Treatment response is defined as improvement, i.e., at least 1-point decreased, in the ADOS-2 SA For ADOS-2 SA, higher scores means more severe symptom.
Measured: Pre-treatment (baseline), follow-up (24-week)
ADOS-2 total CSS change with treatment
The ADOS-2 total CSS score change from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
SCQ score change with treatment
The SCQ (Social Communication Questionnaire) score change from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
CBCL score change with treatment
The CBCL (Child Behavior Checklist) score change from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
QoL score change with treatment
The QoL (quality of life) score change from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
AIM score change with treatment
The AIM (Autism Impact Measure) score change from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changping Laboratory
- Sponsor type
- University, hospital or other
- Collaborators
- Xi'an TCM Hospital of Encephalopathy, Linyi Hedong Rehabilitation Hospital, Jining Medical University, Fujian Maternity and Child Health Hospital, Hebei Provincial Mental Health Center
- Responsible party
- Sponsor
- Investigators
- Hesheng Liu, Ph.D., Study chair, Changping Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255535
- Sponsor's protocol ID
- CPASD05DL_Multicenter
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Low-Functioning Autism Spectrum Disorder: a Multi-center, Randomized, Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT06255535
- Acronym / sponsor ID
- CPASD05DL_Multicenter
- Conditions
- Autism Spectrum Disorder
- Keywords
- intellectual or development delay, personalized, TMS, functional MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Collaborators
- Xi'an TCM Hospital of Encephalopathy, Linyi Hedong Rehabilitation Hospital, Jining Medical University, Fujian Maternity and Child Health Hospital, Hebei Provincial Mental Health Center
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this trial is to assess the efficacy and safety of precision neuromodulation for alleviating core symptoms in patients with autism spectrum disorder (ASD) who also have intellectual or developmental delay. The neuromodulation will be administered using intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC), guided by personalized Brain Functional Sector (pBFS) technology.
Detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by impaired social communication and repetitive behaviors. Unfortunately, evidence-based treatments have not proven effective for older individuals with low-functioning ASD, despite their significant need for intensive support. However, emerging evidence suggests that Transcranial Magnetic Stimulation (TMS) has been successful in treating various psychiatric and neurological disorders.
Given the broad cognitive control dysfunction observed in ASD, targeting cognitive control function may offer a promising treatment approach. Leveraging the personalized Brain Functional Sector (pBFS) technique and task-free functional MRI scans, we can precisely locate the cognitive control function region within the left DLPFC, and follow-up at 24-week after initiation of treatment.
In this study, participants who meet the inclusion and exclusion criteria will be randomly assigned to either active or sham iTBS (intermittent theta burst stimulation) groups at a ratio of 2:1. The treatment protocol consists of a 12-week duration, with sessions conducted 5 days per week and 3 sessions iTBS over DLPFC per day. The inter-session interval is set at 30 minutes. Clinical evaluations focusing on ASD core symptoms and related behavioral profiles will be conducted at baseline and after the 12-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active iTBS group | Experimental | Device: active iTBS treatmentactive iTBS over DLPFC |
| Sham group | Sham comparator | Device: sham iTBS treatmentsham iTBS over DLPFC |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 6-30 years old
- Have the diagnosis of autism spectrum disorder
- ADOS-2 score is higher than the ASD cut-offs
- Comorbid with intelligent disorder, IQ/DQ < 70
- Primary environmental language is Chinese
Key exclusion criteria (10 listed)
- Genetic Disorders, such as (e.g., Down syndrome, Fragile X syndrome, Rett syndorme), Current or history of severe ADHD, tourette syndrome, psychotic disorders (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
- Severe self-injury or suicidal behavior exhibited within the past year
- Significant visual, auditory, deafness or motor disability that prevent them from following study procedures
- Current or history diagnosis of epilepsy
- Known severe physical diseases, particularly those affecting the brain
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 iTBS treatmentParticipants will undergo three iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Individualized targets will be generated using the pBFS technique. | Device | active iTBS group |
| sham iTBS treatmentParticipants will undergo three iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Sham stimulation will be delivered through a sham coil with the identical appearance as real coil. Individualized targets will be generated using the pBFS technique. | Device | Sham group |
Primary outcome
ADOS-2 SA CSS score change after treatment
Time frame: Pre-treatment (baseline), post-treatment (12-week)
The score changes of ADOS-2 SA CSS (Autism Diagnostic Observation Scale, 2nd edition, social affect domain, calibrated severity score) at 12-week from baseline. Higher scores mean a worse outcome.
8 secondary outcomes
ADOS-2 SA CSS score change from baseline to follow-up
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
Response rate in social ability after 12-week iTBS treatment
Time frame: Pre-treatment (baseline), post-treatment (12-week)
Response rate in social ability at 24-week follow-up
Time frame: Pre-treatment (baseline), follow-up (24-week)
ADOS-2 total CSS change with treatment
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
SCQ score change with treatment
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
CBCL score change with treatment
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
QoL score change with treatment
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
AIM score change with treatment
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- 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.
Hesheng Liu, Ph.D. study chair
Changping Laboratory
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active iTBS treatment in people with Autism Spectrum Disorder, run by Changping Laboratory at 6 sites in China.
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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Liu, Ph.D. (010-80726688, liuqi@cpl.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADOS-2 SA CSS score change after treatment (time frame: Pre-treatment (baseline), post-treatment (12-week)). 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 21 Feb 2025.