tRNS Treatment for ADHD Symptoms
- Conditions
- ADHD
- Interventions
- Device: tRNS
- Registration Number
- NCT06189703
- Lead Sponsor
- Innosphere
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 146
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: Treatment Arm tRNS The same device placement will be used for sham as in the active arm. Group B: Sham-Control Arm tRNS The same device placement will be used for sham as in the active arm.
- Primary Outcome Measures
Name Time Method Incidence of adverse events 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 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.
- Secondary Outcome Measures
Name Time Method 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 from baseline to follow-up (Week 4 and Week 10) compared to sham control
GCI-I score Baseline to End of Treatment (Week 2), Follow-up 1 (Week 4) and Follow-up 2 (Week 10) CGI-I score at end of treatment and follow-up (Week 4 and Week 10) compared to sham control
Change in ADHD-RS subscales Baseline to End of Treatment (Week 2), Follow-up 1 (Week 4) and Follow-up 2 (Week 10) Change in ADHD-RS subscales (either inattention or hyperactivity-impulsivity subscales) from baseline to end of treatment and follow-up (Week 4 and Week 10) compared to sham control
Trial Locations
- Locations (4)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Mayo Clinic Hospital, Methodist Campus
🇺🇸Rochester, Minnesota, United States
Baylor College of Medicine Department of Psychiatry & Behavioral Sciences
🇺🇸Houston, Texas, United States
UTHealth Houston
🇺🇸Houston, Texas, United States