tRNS treatment for ADHD symptoms in children
tRNS Treatment for ADHD Symptoms
This study is testing if a new brain stimulation treatment can help children aged 7-12 with ADHD feel better without medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | Innosphere Industry-sponsored |
| Locations | 4 sites (Boston, Massachusetts and 3 other locations) |
| Trial ID | NCT06189703 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of transcranial random noise stimulation (tRNS) in unmedicated pediatric patients aged 7-12 years with ADHD. Participants will be randomly assigned to receive either active tRNS or a sham treatment over a two-week period, with each session lasting 20 minutes and incorporating a software game to maintain attention. The study aims to assess the impact of tRNS on ADHD symptoms using standardized measures.
Who should consider this trial
Good fit: Ideal candidates are unmedicated children aged 7-12 years who meet the DSM-5 criteria for moderate to severe ADHD.
Not a fit: Patients with significant head injuries or those who do not meet the ADHD diagnostic criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-pharmacological option for managing ADHD symptoms in children.
How similar studies have performed: While the use of tRNS is a novel approach in this context, similar non-invasive brain stimulation techniques have shown promise in treating ADHD symptoms in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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))
Where this trial is running
Boston, Massachusetts and 3 other locations
- Boston Children's Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Mayo Clinic Hospital, Methodist Campus — Rochester, Minnesota, United States (Recruiting)
- Baylor College of Medicine Department of Psychiatry & Behavioral Sciences — Houston, Texas, United States (Not_yet_recruiting)
- UTHealth Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Rami Shacour
- Email: Rami.shacour@inno-sphere.com
- Phone: +972-52-872-3640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.