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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
146
transcranial random noise stimulation applied to the right IFG and the left DLPFC
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
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.
Time frame: 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
Time frame: Baseline to Week 10
Change in ADHD symptom severity post-treatment
Change in ADHD-RS from baseline to follow-up (Week 4 and Week 10) compared to sham control
Time frame: Baseline to Follow-up 1 (Week 4) and to Follow-up 2 (Week 10)
Change in ADHD-RS subscales
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
Time frame: Baseline to End of Treatment (Week 2), Follow-up 1 (Week 4) and Follow-up 2 (Week 10)
GCI-I score
CGI-I score at end of treatment and follow-up (Week 4 and Week 10) compared to sham control
Time frame: Baseline to End of Treatment (Week 2), Follow-up 1 (Week 4) and Follow-up 2 (Week 10)
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Hadassah Medical Center
Jerusalem, Israel