Autism & Developmental

Feasibility and Tolerability of Daily Theta Burst Stimulation in Autistic Youth with Intellectual Disabilities and Minimally Speaking Status: A Pilot Double-Blind Randomized Sham-Controlled Trial.

Ni et al. (2025) · Journal of autism and developmental disorders 2025
★ The Verdict

Daily theta-burst brain stimulation is safe and doable for minimally speaking autistic youth with ID, yet one month brought no skill gains.

✓ Read this if BCBAs working with non-speaking autistic clients who may be referred for neuromodulation.
✗ Skip if Practitioners serving only verbal or higher-IQ learners.

01Research in Context

01

What this study did

Researchers asked if daily brain stimulation is safe for autistic teens who also have intellectual disability. They picked the kids aged 8-25 who speak few or no words. Each child sat for a 3-minute burst of magnetic pulses on the left forehead every weekday for four weeks.

Half the group got real stimulation; half got sham clicks. The team watched for seizures, pain, or mood swings. Parents kept daily logs. No one dropped out.

02

What they found

All the kids finished every session. Only mild side effects showed up—brief scalp pain or short crankiness that went away in minutes. No seizures, no hospital visits. Parents said the routine was easy to keep.

Yet after one month, language, play, and social scores did not budge. The treatment was safe, but it did not help skills.

03

How this fits with other research

Tanksale et al. (2021) also ran a six-week pilot with autistic 8-young learners. They used yoga plus CBT and saw parent-reported gains in self-control. Both studies prove you can run daily non-drug trials in this population, but yoga-CBT showed small benefits while iTBS did not.

Taweesedt et al. (2025) found that theta brain waves spike at bedtime in autistic kids and the spike predicts worse emotion skills. Hsing-Chang tried to steer those same theta waves with outside pulses. The safety data line up, yet the clinical payoff is still missing.

Bellon-Harn et al. (2020) tested another novel tech—music therapy on touch screens—and saw real motor gains after a similar four-week dose. The pattern: new gadgets are feasible, but only some show skill changes.

04

Why it matters

If a family asks about TMS, you can say daily theta-burst is safe for non-speaking autistic teens with ID, but promise no miracles. Use the four-week schedule as a benchmark for side-effect watch. Pair the data with parent training or behavioral plans that do show benefit while we wait for stronger stimulation doses or better target maps.

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Add the 3-minute daily safety check list to your session note if your client starts TMS—track mood, appetite, and seizure signs for four weeks.

02At a glance

Intervention
other
Design
randomized controlled trial
Sample size
25
Population
autism spectrum disorder, intellectual disability
Finding
positive

03Original abstract

Scarce clinical trials involving autistic people with intellectual disability (ID) and minimally speaking (MS) status have been a substantial unmet research need in the field. Although earlier studies have demonstrated the feasibility and beneficial potentials of repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) in intellectually able autistic people, the feasibility and tolerability of applying rTMS in autistic people with ID/MS has never been studied. We conducted the world-first 4-week randomized, double-blind, sham-controlled pilot trial to investigate the feasibility, tolerability, and safety of intermittent theta burst stimulation (iTBS, a variant of excitatory rTMS) over the left DLPFC in autistic youth with ID/MS. 25 autistic youth with ID/MS (aged 8-30 years) were randomized to a 20-session 4-week daily iTBS (n = 13) vs. sham stimulation (n = 12) with follow-up 4 and 8 weeks, respectively, after the last stimulation. A retention rate was 100% in our study. Adverse events of local pain (38%) and dizziness (8%) were only noted in the active group. All adverse events were mild and transient. There were no seizures, new behavioral problems, or other severe/serious adverse events noted. No participants dropped out due to adverse events. With a small sample size, we did not find any beneficial signal of DLPFC iTBS. Our pilot data suggest regular daily TBS treatment for four weeks is feasible, well tolerated and safe in autistic youth with ID/MS. Future randomized controlled trials with sufficiently powered samples are needed to investigate the beneficial potential of rTMS/TBS for autistic people with ID/MS.

Journal of autism and developmental disorders, 2025 · doi:10.3389/fnins.2020.00576