Could a headset tame ADHD without meds? new trial tests brain zaps in kids
NCT ID NCT06189703
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a non-invasive device called tRNS can safely reduce ADHD symptoms in children aged 7 to 12 who are not on medication. Over 10 sessions in two weeks, kids receive either real or sham stimulation while playing a computer game. Researchers track symptom changes and side effects for up to 10 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcranial random noise stimulation (tRNS) device
- What this could lead to
- If it works, this could offer a drug-free option to reduce ADHD symptoms in children, with effects lasting weeks after treatment.
- What could go wrong
- This is an early-stage trial with no phase, so results are uncertain. The treatment is short-term (10 sessions) and may not work for all children. Side effects, though likely mild, are not yet fully known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 146 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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7 to 12 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA: 1. Age between 7-12 years old at the time of enrollment 2. Estimated Full Scale IQ ≥ 85 based on WASI-II (Two-subtests Form) NOTE: Results of an equivalent and validated IQ test that were performed in the previous 12 months from the date of enrollment are acceptable. The Investigator must ensure that no significant head injuries, particularly significant head trauma, occurred in this period from the previous test to the enrollment. 3. Score above the standard clinical cut-off score for ADHD symptoms on the ADHD DSM-5 scales 4. Meet criteria for ADHD according to DSM-5, using the "gold standard" procedure as described by the American Academy of Pediatrics, which includes a semi-structured interview of the subject and parent(s)/legal guardian(s) 5. Moderate to severe ADHD as defined as having a minimum score of 12 on either the inattention subscale or the and hyperactivity-impulsivity subscale of the baseline ADHD Rating Scale (ADHD-RS), and a Clinical Global Impression-Severity (CGI-S) score at baseline of greater than 4 6. Parent(s)/legal guardian(s) fluent in English, able to complete ADHD-RS scale and attend all study visits 7. Has not taken any medication with central nervous system effects, including prescription medications for ADHD, within 7 days of enrollment, as determined by the investigator based on the subject's medical history from the parent(s)/legal guardian(s) and, as applicable, medical and pharmacy records EXCLUSION CRITERIA: 1. Has a history of any medical or psychiatric disorder, disease, condition, injury, symptoms or circumstance that, in the opinion of the principal investigator, may: (1) reduce the subject's ability to fulfill the study requirements as per protocol; or (2) adversely impact the integrity of the data or the validity of the study results 2. Primary DSM-5 axis-1 disorder other than ADHD, which consists of one or more of severe ODD, bipolar psychosis, major depressive disorder, severe oppositional defiant disorder that would pose adherence challenges by the investigator 3. Substance abuse, that, in the opinion of the investigator, may: (1) reduce the participant's ability to fulfill the study requirements as per protocol; or (2) adversely impact the integrity of the data or the validity of the study results 4. Impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the Investigator 5. Known hypersensitivity to Polyamide or Elastomer 6. Any suicide risk as assessed with the Columbia-Suicide Severity Rating Scale (Pediatric (≤11 years) Quick Screen) 7. If female, began menstruation, based on a self- or parent(s)/legal guardian(s)-report 8. Any other condition, which would make the participant unsuitable to participate in this study as determined by the Investigator 9. Inability to provide informed consent and assent (participant and parent(s)/legal guardian(s))
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baylor College of Medicine Department of Psychiatry & Behavioral Sciences
Houston, Texas, 77030, United States
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Boston Children's Hospital
Boston, Massachusetts, 02115, United States
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Hadassah Medical Center
Jerusalem, Israel
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Mayo Clinic Hospital, Methodist Campus
Rochester, Minnesota, 55902, United States
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UTHealth Houston
Houston, Texas, 77030, United States
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