Clinical trial NCT06189703: tRNS Treatment for ADHD Symptoms
Official title: tRNS Treatment for ADHD Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Keywords: Pediatric
Lead sponsor: Innosphere
Sponsor class: INDUSTRY
First posted: 2024-01-03
Enrollment: 146
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, sham-controlled between groups
Primary purpose: TREATMENT

Brief summary: A randomized, sham-controlled, double-blind clinical trial to examine the safety and effectiveness of tRNS on unmedicated pediatric patients (7-12 years) with ADHD. Subjects will undergo either tRNS or sham treatment for 10 days during a two-week period in a home-simulated environment. Each treatment session is 20 minutes, during which their attention will be maintained using a software game.


Eligibility 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))

Primary outcomes:
measure: Change in ADHD symptom severity during treatment
timeFrame: Baseline to End of Treatment (Week 2)
measure: Incidence of adverse events
timeFrame: Baseline to Week 10
Secondary outcomes:
measure: Change in ADHD symptom severity post-treatment
timeFrame: Baseline to Follow-up 1 (Week 4) and to Follow-up 2 (Week 10)
measure: Change in ADHD-RS subscales
timeFrame: Baseline to End of Treatment (Week 2), Follow-up 1 (Week 4) and Follow-up 2 (Week 10)
measure: GCI-I score
timeFrame: Baseline to End of Treatment (Week 2), Follow-up 1 (Week 4) and Follow-up 2 (Week 10)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Hospital, Methodist Campus
state: Minnesota
city: Houston
country: United States
facility: Baylor College of Medicine Department of Psychiatry & Behavioral Sciences
state: Texas
city: Houston
country: United States
facility: UTHealth Houston
state: Texas
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References: