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Status unknownNCT05578261Updated Aug 31, 2023

Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder

An interventional study of intermittent theta burst stimulation in Autism Spectrum Disorder, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-31.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The investigator would like to investigate the impact of theta-burst stimulation over cerebellum in adults with autism spectrum disorder

02

Conditions studied

  • Autism Spectrum Disorder
03

In context

Autism Spectrum Disorder

1,755 studies on the registry are indexed under Autism Spectrum Disorder; 507 are open to participants now.

This study's enrollment of 10 is below the median of 52 across 1,391 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,091 studies on the registry; 238 are open to participants now.

Browse Chang Gung Memorial Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults with autism spectrum disorder (≥18 years old), confirmed by Autism Diagnostic Observation Schedule.

Exclusion criteria

Exclusion Criteria:

  • Previous or current severe neurological disorder such as epilepsy, visual or hearing impairment.
  • Previous or current severe systemic disease such as cardiovascular disease, diabetes or infection.
  • Previous or current severe brain injury
  • Implementation of metal materials such as pacemaker or medication pump
  • Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder or substance abuse
  • Pregnancy
  • Individuals with a significant brain abnormality such as intracranial space occupied lesions
  • History of brain surgery or nervous system infection, such as meningitis and encephalitis
  • Concurrent use of medications which increased the risk of seizure attack
  • Participate another clinical trial within one month
  • Skin trauma on application site
  • Individuals suffering from multiple sclerosis
  • Individuals with a large ischemic scar
  • Individuals suffering from sleep deprivation during rTMS procedures
  • Individuals with a heavy consumption of alcohol
  • Current taking antiepileptic drugs
  • Individuals with a migraine headache from increased intracranial pressure
  • Unable to complete MRI scan

Withdrawal criteria:

  • Seizure attack during study period
  • Autistic symptoms worsened obviously during study period
  • Extreme agitation or irritability during study period
  • Participants request
  • Take antiepileptic drug during study period
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Active

    All of the participants will accept one session iTBS over right Crus I/II. The total pulses of every session are 1200 pulses (600 pulses with 15 minutes interval) \*iTBS = intermittent theta burst stimulation.

    Device: intermittent theta burst stimulation

Interventions

  • Deviceintermittent theta burst stimulation

    stimulatory protocol

06

What researchers measure

Primary outcomes

  1. Adverse effects report form (Headache)

    Recording adverse effects in participants after iTBS.

    Time frame: 1 week after iTBS (post iTBS)

  2. Adverse effects report form (Dizziness)

    Recording adverse effects in participants after iTBS.

    Time frame: 1 week after iTBS (post iTBS)

  3. Adverse effects report form (Tinnitus)

    Recording adverse effects in participants after iTBS.

    Time frame: 1 week after iTBS (post iTBS)

  4. Adverse effects report form (Seizure)

    Recording adverse effects in participants after iTBS.

    Time frame: 1 week after iTBS (post iTBS)

  5. Adverse effects report form (Other)

    Recording adverse effects in participants after iTBS.

    Time frame: 1 week after iTBS (post iTBS)

Secondary outcomes

  1. MRI T1

    Brain structural volumes (cm²)

    Time frame: Within one month

  2. functional MRI (resting-state/biological motion task) - BOLD signal

    Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.

    Time frame: Within one month

07

Study locations

1 site
  • Chang Gung Memorial Hospital
    Taoyuan, Taiwan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2022 (actual). Primary completion is estimated for Dec 2023, 12 months after the start.

Of 801 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 12 months is below that.

Counting every sponsor, half of 825 studies reached it within 25 months; a quarter within 12 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2022
First posted
Oct 13, 2022
StartActual
Dec 28, 2022
Primary completionEst.
Dec 2023
CompletionEst.
Dec 2023
Last update
Aug 31, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05578261
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Oct 13, 2022
Start date
Dec 28, 2022
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Aug 31, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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