Intermittent Theta Burst Stimulation for ADHD

(WINK Trial)

Overseen By Brian K Kavanaugh, PsyD; PI, PsyD ABPP

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Bradley Hospital

Must not be taking: Seizure threshold-lowering drugs

Disqualifiers: Epilepsy, Seizures, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

Duration: 2 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a brain stimulation treatment, intermittent theta burst stimulation (iTBS), might alleviate ADHD symptoms by targeting working memory and inhibitory control. Researchers are testing two different brain areas to determine which is more effective in enhancing these skills. The trial seeks adolescents with ADHD who have parent-reported issues with memory and self-control. Participants should have experienced these challenges for some time and meet specific ADHD diagnosis criteria. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on ADHD treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on medications that lower the seizure threshold, except for psychostimulants if considered safe. It's best to discuss your specific medications with the trial team.

What prior data suggests that intermittent theta burst stimulation (iTBS) is safe for adolescents with ADHD?

Research has shown that intermittent theta burst stimulation (iTBS) is generally safe for children with ADHD. In one study, 165 young participants received iTBS, and researchers reported no serious side effects like seizures. Mild side effects occurred in 10.5% of cases, but these were not severe and did not require stopping the treatment.

Another study on iTBS showed promising results for improving ADHD symptoms without major safety concerns. Although this treatment is not yet approved for ADHD, these findings suggest it is well-tolerated. It is important to consult a healthcare provider to discuss potential risks and benefits before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Intermittent Theta Burst Stimulation (iTBS) for ADHD because it offers a new approach by using targeted brain stimulation. Unlike standard treatments like medication and behavioral therapy, iTBS involves non-invasive magnetic pulses to stimulate brain regions associated with attention and impulse control. This method has the potential to deliver quicker results and fewer side effects compared to traditional options. Additionally, with different stimulation targets, such as the left DLPFC and right pre-SMA, iTBS could provide tailored treatments based on individual patient needs.

What evidence suggests that this trial's treatments could be effective for ADHD?

This trial will compare two different applications of intermittent theta burst stimulation (iTBS) for treating ADHD in teenagers. Research has shown that iTBS, which involves repeated brain stimulation, may help treat ADHD. In one study, 75% of participants noticed an improvement in their ADHD symptoms after undergoing iTBS sessions twice a day for 10 days. Another study found that intensive iTBS sessions resulted in a 79% remission rate, significantly better than typical treatment outcomes. These findings suggest that iTBS might improve issues like working memory and self-control in teens with ADHD. Although more research is needed, the early results are promising for those considering this treatment. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-18 with ADHD, specifically those who have working memory and inhibitory control deficits as reported by parents. Participants must be diagnosed with ADHD to qualify.

Inclusion Criteria

IQ > 70

English fluency of participant and parent and able to provide informed consent/assent

Parent rating on The Behavior Rating Inventory of Executive Function-Second Edition (BRIEF-2), Parent Form: Working Memory scale T-Score > 60 AND Inhibition scale T-Score > 60

Exclusion Criteria

Vagal nerve stimulator, deep brain stimulator, or transcutaneous electrical nerve stimulation unit

Contraindicated metal implants in the head, brain or spinal cord (excluding dental implants or fillings)

Non-removable makeup or piercings

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3x-daily iTBS targeting either the left DLPFC or right PreSMA for a total of ten days (30 total sessions)

2 weeks

30 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Theta Burst Stimulation (iTBS)

Trial Overview The study tests intermittent theta burst stimulation (iTBS) targeting two brain areas: the left DLPFC or right PreSMA. It aims to see which area's stimulation improves working memory and inhibitory control in ADHD patients over ten days.

How Is the Trial Designed?

Group I: iTBS to the left DLPFC Experimental Treatment 1 Intervention

Group II: iTBS to the right pre-SMA Active Control 1 Intervention

Who Is Running the Clinical Trial?

Bradley Hospital

Lead Sponsor

Trials

22

Recruited

1,900+

Citations

1. medrxiv.org medrxiv.org/content/10.1101/2025.09.03.25335033v1

Intermittent theta burst stimulation for attention deficit ... Intermittent theta burst stimulation for attention deficit hyperactivity disorder ... efficacy and feasibility for teens with ADHD and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07084649

NCT07084649 | Dual-target iTBS for Youth With ADHD Phase 1: A randomized, double-masked, controlled trial that will rigorously validate the efficacy and safety of dual-target aiTBS for youth with ADHD.

3. medrxiv.org medrxiv.org/content/10.1101/2025.09.03.25335033v1.full-text

Intermittent theta burst stimulation for attention deficit ... Following 10 days of twice daily iTBS, three out of four (75%) participants experienced categorical ADHD symptom response and also ADHD symptom ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11238064/

Accelerated Intermittent Theta-Burst Stimulation and ... Ten sessions per day for 5 days achieved 79% remission in a sham-controlled randomized clinical trial—substantially better than remission rates ...

5. researchgate.net researchgate.net/publication/395485552_Intermittent_theta_burst_stimulation_for_attention_deficit_hyperactivity_disorder

Intermittent theta burst stimulation for attention deficit ... Background: Recent studies support the possible effectiveness of rTMS as a treatment for ADHD. Objectives: To evaluate the safety and possible ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4316715/

Safety and tolerability of theta burst stimulation vs. single ... Result: Overall, no seizures or severe-rated AEs were reported by 165 pediatric participants. The rate of AE in all TBS sessions was 10.5% (n = ...

7. trial.medpath.com trial.medpath.com/clinical-trial/83acaf7687f9877b/nct07182344-itbs-effects-cognitive-control-children-adhd

Brain Stimulation and Attention Control in Children With ADHD The goal of this clinical trial is to learn if brain stimulation can help children ages 6 to 12 with attention-deficit/hyperactivity ...