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Non-invasive Brain Stimulation

Brain Stimulation for ADHD-Related Working Memory Deficits

N/A
Recruiting
Research Sponsored by Bradley Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
13-18 years
IQ > 80
Timeline
Screening 3 weeks
Treatment Varies
Follow Up theta-gamma coupling will be obtained before and after itbs administration. there will be approximately 5 minutes between the pre and post eeg recordings. the change between pre and post is the outcome variable.
Awards & highlights

Study Summary

This trial will test if a single session of brain stimulation can help with 'working memory,' which is the ability to keep information in mind for everyday activities. The study includes teenagers with ADHD.

Who is the study for?
This trial is for teens aged 13-18 with ADHD and working memory issues, as well as healthy young adults aged 18-25. Participants must speak English fluently, have an IQ over 80, and not be diagnosed with any psychiatric disorders (for the healthy group). Teens need parental consent.Check my eligibility
What is being tested?
The study tests if a single session of brain stimulation called rTMS can improve 'working memory' in teenagers with ADHD and in healthy young adults. It's a pilot project by The COBRE Center for Neuromodulation at Butler Hospital.See study design
What are the potential side effects?
Potential side effects of rTMS may include discomfort at the stimulation site, headache, lightheadedness or fainting. Seizures are rare but possible; hence individuals prone to seizures are excluded from the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 13 and 18 years old.
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My IQ is above 80.
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I am between 13 and 18 years old.
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I am between 18 and 25 years old.
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I am between 18 and 25 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~theta-gamma coupling will be obtained before and after itbs administration. there will be approximately 5 minutes between the pre and post eeg recordings. the change between pre and post is the outcome variable.
This trial's timeline: 3 weeks for screening, Varies for treatment, and theta-gamma coupling will be obtained before and after itbs administration. there will be approximately 5 minutes between the pre and post eeg recordings. the change between pre and post is the outcome variable. 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 Theta-Gamma Coupling After Sham iTBS
Change in Theta-Gamma Coupling after Active iTBS

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patient ArmExperimental Treatment1 Intervention
In a 2x2 factorial double-blind design, we will randomize a sample of adolescents (13-18 years) with WM deficits to intermittent theta burst stimulation (iTBS) at the left dorsolateral prefrontal cortex (DLPFC) or inferior parietal lobule (IPL), based on each participant's structural brain MRI. Participants in both arms will complete an active iTBS session and a sham iTBS session. The primary outcome will be theta-gamma coupling during WM demands, as measured via electroencephalography (EEG) during a Sternberg spatial WM task (SWMT) immediately before and after iTBS.
Group II: Healthy Control ArmExperimental Treatment1 Intervention
Control Arm: A sample of healthy young adults (18-25 years) will receive an individualized theta-gamma parameters protocol of iTBS to the left DLPFC. Participants in both arms will complete an active iTBS session and a sham iTBS session. The primary outcome will be theta-gamma coupling during WM demands, as measured via electroencephalography (EEG) during a Sternberg spatial WM task (SWMT) immediately before and after iTBS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intermittent Theta Burst Stimulation
2020
N/A
~50

Find a Location

Who is running the clinical trial?

Bradley HospitalLead Sponsor
16 Previous Clinical Trials
1,469 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
295 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Funding Source: COBRE Center for Neuromodulation at Butler Hospital (Pilot Project)UNKNOWN

Frequently Asked Questions

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

Will participants aged 40 or older be accepted for this experimental protocol?

"According to the trial's guidelines, prospective participants must be between 13 and 18 years of age. Additionally, there are 101 clinical trials available for minors and 53 studies open to geriatric patients."

Answered by AI

What is the enrolment capacity of this research program?

"Indeed, clinicaltrials.gov has the most current information indicating that this clinical trial is actively enrolling patients. Initially posted on October 1st 2021, and last updated February 22nd 2022, the study aims to recruit 25 individuals from one medical centre."

Answered by AI

Is this test actively enlisting volunteers?

"As advertised on clinicaltrials.gov, this research is currently in the midst of patient recruitment with a start date of October 1st 2021 and recent amendment on February 22nd 2022."

Answered by AI

Who is eligible to enroll in this clinical experiment?

"This research study is searching for 25 adolescents (ages 13-18) with Attention Deficit Hyperactivity Disorder (ADHD). The participants must be able to provide assent and have a legal guardian/parent give their permission, understand English fluently, score 1.0 SD above the normal range of working memory on BRIEF-2 Working Memory assessment, possess an IQ over 80, and meet clinical criteria of ADHD as confirmed by NICHQ Vanderbilt Assessment Scales-Parent evaluations"

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Pennsylvania
New Jersey
Other
How old are they?
18 - 65
What site did they apply to?
E. P. Bradley Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Modulation of Frontoparietal Dynamics Underlying Adolescent Working Memory Deficits
2021. "Modulation of Frontoparietal Dynamics Underlying Adolescent Working Memory Deficits". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05119660.
~7 spots leftby Apr 2025
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