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Electrical Brain Stimulation Device

Group A: Treatment Arm for Attention Deficit Hyperactivity Disorder (ADHD)

N/A
Waitlist Available
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)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ADHD symptom severity during treatment
Incidence of adverse events
Secondary outcome measures
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants currently able to apply for enrollment in this ongoing clinical trial?

"I apologize for the incorrect information. According to clinicaltrials.gov, this particular study is not actively recruiting participants at the moment. The trial was initially posted on January 17th, 2024 and last updated on December 19th, 2023. However, there are currently 148 other ongoing clinical trials seeking eligible candidates at this time."

Answered by AI

Do I meet the necessary criteria to be considered as a potential candidate for participation in this clinical trial?

"To be eligible for enrollment in this study, potential participants must have a diagnosis of attention deficit hyperactivity disorder (ADHD) and fall within the age range of 7 to 12 years old. The trial aims to enroll approximately 128 patients."

Answered by AI

Is there an age restriction for the recruitment of participants in this trial, specifically regarding individuals who are above 70 years old?

"This clinical trial welcomes participants who are at least 7 years old but not yet 12 years old."

Answered by AI

Who else is applying?

What site did they apply to?
Baylor College of Medicine Department of Psychiatry & Behavioral Sciences
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
tRNS Treatment for ADHD Symptoms
2024. "tRNS Treatment for ADHD Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06189703.
All > Adhd
~97 spots leftby Apr 2025
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