tRNS Treatment for ADHD Symptoms

NCT06189703 | Active Not Recruiting FDA Device

• 1 other identifier: TRNS-CLIN-003
• Study Type: interventional
• Target: 146
• Locations: 2 countries
• Sites: 5

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.

Conditions

ADHD

Keywords

Pediatric

Outcome Measures

Primary Outcomes (2)

• Change in ADHD symptom severity during treatment

  Change in ADHD symptom severity, measured by total score of parent-reported ADHD-RS questionnaire from baseline to End of Treatment (Week 2) compared to sham control.

  Baseline to End of Treatment (Week 2)

• Incidence of adverse events

  Incidence of adverse events (AEs), including serious adverse events (SAEs) related to Novostim 2 treatment

  Baseline to Week 10

Secondary Outcomes (3)

• Change in ADHD symptom severity post-treatment

  Baseline to Follow-up 1 (Week 4) and to Follow-up 2 (Week 10)

• Change in ADHD-RS subscales

  Baseline to End of Treatment (Week 2), Follow-up 1 (Week 4) and Follow-up 2 (Week 10)

• GCI-I score

  Baseline to End of Treatment (Week 2), Follow-up 1 (Week 4) and Follow-up 2 (Week 10)

Study Arms (2)

Group A: Treatment Arm

ACTIVE COMPARATOR

The same device placement will be used for sham as in the active arm.

Device: tRNS

Group B: Sham-Control Arm

SHAM COMPARATOR

The same device placement will be used for sham as in the active arm.

Device: tRNS

Interventions

tRNS DEVICE

transcranial random noise stimulation applied to the right IFG and the left DLPFC

Also known as: Novostim 2

Group A: Treatment Arm; Group B: Sham-Control Arm

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 7-12 years old at the time of enrollment
• 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.
• Score above the standard clinical cut-off score for ADHD symptoms on the ADHD DSM-5 scales
• 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)
• 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
• Parent(s)/legal guardian(s) fluent in English, able to complete ADHD-RS scale and attend all study visits
• 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

You may not qualify if:

• 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
• 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
• 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
• Impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the Investigator
• Known hypersensitivity to Polyamide or Elastomer
• Any suicide risk as assessed with the Columbia-Suicide Severity Rating Scale (Pediatric (≤11 years) Quick Screen)
• If female, began menstruation, based on a self- or parent(s)/legal guardian(s)-report
• Any other condition, which would make the participant unsuitable to participate in this study as determined by the Investigator
• Inability to provide informed consent and assent (participant and parent(s)/legal guardian(s))

Sponsors & Collaborators

• Innosphere: lead

Study Sites (5)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic Hospital, Methodist Campus

Rochester, Minnesota, 55902, United States

Location

Baylor College of Medicine Department of Psychiatry & Behavioral Sciences

Houston, Texas, 77030, United States

Location

UTHealth Houston

Houston, Texas, 77030, United States

Location

Hadassah Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study is double-blind, meaning participants, parents/legal guardians/caregivers, the investigator and all study personnel are blinded. Participants will be randomized in a 1:1 allocation ratio to receive active (Group A) or sham (Group B) tRNS. Randomization will be stratified by age, gender, and baseline ADHD-RS score. Three staff members with no contact with participants will generate balanced random samples throughout the course of the study, using Smith's randomization algorithm based on the variance minimization procedure, and program the respective device to discharge sham/active stimulation according to each participant's allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, sham-controlled between groups

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 3, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); US (4)