Explore the Therapeutic Effect of Theta Burst Stimulation on Emotion Regulation in Autism With Minimally Verbal Ability or Intellectual Disability

Chang Gung Medical Foundation

Status: Not yet enrolling

Conditions: Minimally Verbal Ability; Autism Spectrum Disorder; Intellectual Disability

Treatments: Device: intermittent theta burst stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06974838

202302085A0

Details and patient eligibility

About

The investigator would like to investigate the impact of theta-burst stimulation over left DLPFC in autism with minimally verbal ability or intellectual disability

Enrollment: 60 estimated patients

Sex: All

Ages: 8 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of autism spectrum disorder, confirmed by DSM-5.
• Individuals with minimal verbal ability or intellectual disability (FSIQ < 70).

Exclusion criteria

• Current or past severe neurological disorders, such as epilepsy, or significant visual or hearing impairments.
• Current or past severe systemic diseases, such as cardiovascular disease, diabetes, or multiple sclerosis.
• History of severe brain injury.
• Presence of implanted metal devices, such as a pacemaker or medication pump.
• Current or past severe psychiatric disorders, such as schizophrenia, bipolar disorder, or major depressive disorder.
• Pregnancy.
• Significant brain abnormalities, such as intracranial space-occupying lesions.
• Family history of epilepsy.
• History of febrile seizures.
• Concurrent use of medications that increase the risk of seizures.
• Sleep disorders during rTMS procedures.
• Skin lesions or trauma at the stimulation site.
• Deemed ineligible by the principal investigator (PI).
• Participation in another clinical trial within the past month.
• Suicidal ideation or suicide attempts within the past year.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Active

Active Comparator group

Description:

Participants received the real intervention of TBS (iTBS 1200) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week). \*iTBS = intermittent theta burst stimulation

Treatment:

Device: intermittent theta burst stimulation

Sham

Sham Comparator group

Description:

Participants received the sham intervention of TBS (with sham coil) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week).

Treatment:

Device: intermittent theta burst stimulation