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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Treatment Arm | Active Comparator | The same device placement will be used for sham as in the active arm. |
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| Group B: Sham-Control Arm | Sham Comparator | The same device placement will be used for sham as in the active arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tRNS | Device | transcranial random noise stimulation applied to the right IFG and the left DLPFC |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to Follow-up 1 (Week 4) and to Follow-up 2 (Week 10) |
| Change in ADHD-RS subscales |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Mayo Clinic Hospital, Methodist Campus |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Randomized, double-blind, sham-controlled between groups
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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.
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
| 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 | Baseline to End of Treatment (Week 2), Follow-up 1 (Week 4) and Follow-up 2 (Week 10) |
| Rochester |
| Minnesota |
| 55902 |
| United States |
| Baylor College of Medicine Department of Psychiatry & Behavioral Sciences | Houston | Texas | 77030 | United States |
| UTHealth Houston | Houston | Texas | 77030 | United States |
| Hadassah Medical Center | Jerusalem | Israel |