tRNS Treatment for ADHD Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, sham-controlled between groups

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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Group A: Treatment Arm

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

Group Type ACTIVE_COMPARATOR

tRNS

Intervention Type DEVICE

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

Group B: Sham-Control Arm

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

Group Type SHAM_COMPARATOR

tRNS

Intervention Type DEVICE

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

Interventions

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tRNS

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

Intervention Type DEVICE

Other Intervention Names

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Novostim 2

Eligibility Criteria

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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))

Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No