AutismPhase 1/2NCT01918787
rTMS for Adults With Autistic Spectrum Disorder
A Phase 1/2 study testing repetitive TMS in people with Autism, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
rTMS over dorsolateral prefrontal cortex is effective in reducing repetitive behaviors in adults with autistic spectrum disorder rTMS over posterior superior temporal sulcus is effective in improving social ability in adults with autistic spectrum disorder Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Autism
- What is being tested?
- repetitive TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2012to Apr 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adults with autistic spectrum disorder
Who cannot join
- schizophrenia
- bipolar affective disorder
- major depressive disorder
- any systemic disease especially epilepsy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan
Hsing Chang Ni, 886-3-3281200 ext. 2479, alanni0918@yahoo.com.tw
Hsing Chang Ni, MD
About this study
Official title: Examine the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) Over the Symptoms of Autism Spectrum Disorder
rTMS over dorsolateral prefrontal cortex is effective in reducing repetitive behaviors in adults with autistic spectrum disorder rTMS over posterior superior temporal sulcus is effective in improving social ability in adults with autistic spectrum disorder
Read the detailed description
First, we will apply one session intermittent theta burst stimulation over dorsolateral prefrontal cortex, posterior superior temporal sulcus and inion as control with one week interval in adults with autism spectrum disorder. Second, we will apply 5 sessions intermittent theta burst stimulation within one week over dorsolateral prefrontal cortex or posterior temporal sulcus depending on the results of our first phases.
- Conditions
- Autism
- Being tested
- repetitive TMS
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive TMSDevice
rTMS (intermittent theta burst stimulation 1200)over posterior superior temporal sulcus,dorsolateral prefrontal cortex and inion as Sham control
| Study group | Role | What they receive |
|---|---|---|
| repetitive TMS | Experimental | repetitive TMS over dorsolateral prefrontal cortex, posterior superior temporal sulcus and inion as control Receives: Device: repetitive TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
continuous performance test
continuous performance test will be arranged before and after rTMS within one hour
Measured: continuous performance test will be arranged before and after rTMS within one hour
Secondary outcomes (1)
Yale-Brown Obsessive Compulsive Scale
Yale-Brown Obsessive Compulsive Scale will be evaluated before and after rTMS. The time point of evaluation is before rTMS, one hour after rTMS, 3 days after rTMS and one week after rTMS.
Measured: Yale-Brown Obsessive Compulsive Scale will be evaluated before and after rTMS within one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startApr 2012
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsing-Chang Ni, MD, Principal investigator, Chang Gung Memorial Hospital at Linkou, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918787
- Sponsor's protocol ID
- 100-2985C
- Other IDs
- NSC 100-2314-B-182A-075
- Status last verified
- Apr 2012
- First submitted
- 2 Aug 2013
- Last updated
- 8 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examine the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) Over the Symptoms of Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT01918787
- Acronym / sponsor ID
- 100-2985C
- Conditions
- Autism
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 8 Aug 2013 (estimated)
- 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.
rTMS over dorsolateral prefrontal cortex is effective in reducing repetitive behaviors in adults with autistic spectrum disorder rTMS over posterior superior temporal sulcus is effective in improving social ability in adults with autistic spectrum disorder
Detailed description
First, we will apply one session intermittent theta burst stimulation over dorsolateral prefrontal cortex, posterior superior temporal sulcus and inion as control with one week interval in adults with autism spectrum disorder. Second, we will apply 5 sessions intermittent theta burst stimulation within one week over dorsolateral prefrontal cortex or posterior temporal sulcus depending on the results of our first phases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| repetitive TMS | Experimental | Device: repetitive TMSrepetitive TMS over dorsolateral prefrontal cortex, posterior superior temporal sulcus and inion as control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adults with autistic spectrum disorder
Key exclusion criteria (4 listed)
- schizophrenia
- bipolar affective disorder
- major depressive disorder
- any systemic disease especially epilepsy
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 |
|---|---|---|
| repetitive TMSrTMS (intermittent theta burst stimulation 1200)over posterior superior temporal sulcus,dorsolateral prefrontal cortex and inion as Sham control | Device | repetitive TMS |
Primary outcome
continuous performance test
Time frame: continuous performance test will be arranged before and after rTMS within one hour
continuous performance test will be arranged before and after rTMS within one hour
1 secondary outcome
Yale-Brown Obsessive Compulsive Scale
Time frame: Yale-Brown Obsessive Compulsive Scale will be evaluated before and after rTMS within one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2013.
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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.
Hsing-Chang Ni, MD principal investigator
Chang Gung Memorial Hospital at Linkou, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing repetitive TMS in people with Autism, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 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: status not confirmed, as of the sponsor's last update on 8 Aug 2013. 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 Taiwan. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsing Chang Ni, MD (886-3-3281200 ext. 2479, alanni0918@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
continuous performance test (time frame: continuous performance test will be arranged before and after rTMS within one hour). 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 8 Aug 2013.