tRNS Treatment for ADHD Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Innosphere
- 入组人数
- 146
- 试验地点
- 5
- 主要终点
- Incidence of adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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))
研究组 & 干预措施
Group A: Treatment Arm
The same device placement will be used for sham as in the active arm.
干预措施: tRNS (Device)
Group B: Sham-Control Arm
The same device placement will be used for sham as in the active arm.
干预措施: tRNS (Device)
结局指标
主要结局
Incidence of adverse events
时间窗: Baseline to Week 10
Incidence of adverse events (AEs), including serious adverse events (SAEs) related to Novostim 2 treatment
Change in ADHD symptom severity during treatment
时间窗: Baseline to End of Treatment (Week 2)
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.
次要结局
- Change in ADHD symptom severity post-treatment(Baseline to Follow-up 1 (Week 4) and to 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))
- Change in ADHD-RS subscales(Baseline to End of Treatment (Week 2), Follow-up 1 (Week 4) and Follow-up 2 (Week 10))