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Electrical Brain Stimulation Device

tRNS for ADHD

N/A
Recruiting
Led By Paul Croarkin
Research Sponsored by Innosphere
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of treatment (week 2), follow-up 1 (week 4) and follow-up 2 (week 10)

Summary

This trial is investigating the safety and effectiveness of a treatment called tRNS on children with ADHD who are not taking medication. The children will either receive the tRNS treatment or a fake treatment for

Who is the study for?
This trial is for children aged 7-12 with ADHD who haven't taken medication for it. They'll be part of a study where they receive tRNS, a noninvasive brain stimulation, while playing a game to help focus their attention.
What is being tested?
The trial tests if tRNS can safely improve attention in kids with ADHD. It's randomized and double-blind, meaning neither the researchers nor participants know who gets real or sham (fake) treatment during the two-week test period.
What are the potential side effects?
tRNS is generally considered safe but may cause mild side effects like itching, tingling on the scalp, headache, or fatigue right after use.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of treatment (week 2), follow-up 1 (week 4) and follow-up 2 (week 10)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of treatment (week 2), follow-up 1 (week 4) and follow-up 2 (week 10) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in ADHD symptom severity during treatment
Incidence of adverse events
Secondary study objectives
Change in ADHD symptom severity post-treatment
Change in ADHD-RS subscales
GCI-I score

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Group A: Treatment ArmActive Control1 Intervention
The same device placement will be used for sham as in the active arm.
Group II: Group B: Sham-Control ArmPlacebo Group1 Intervention
The same device placement will be used for sham as in the active arm.

Find a Location

Who is running the clinical trial?

InnosphereLead Sponsor
Paul CroarkinPrincipal InvestigatorMayo Clinic
Eric StorchPrincipal InvestigatorBaylor College of Medicine
~55 spots leftby Apr 2025
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