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Non-invasive Brain Stimulation
Brain Stimulation for ADHD
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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up theta-gamma coupling will be obtained before the 1st session, and 24 hours after the 1st, 5th, and 10th sessions. statistical modeling will examine the change across these four time points. this change is considered a single primary outcome variable.
Awards & highlights
Summary
This trial tests if a device that sends small electrical pulses to the brain can help teenagers with ADHD improve their memory and attention. The treatment targets a specific brain area to make brain waves work better together.
Who is the study for?
This trial is for teenagers aged 13-18 with ADHD, an IQ over 80, and specific working memory challenges. They must have a clinical diagnosis of ADHD confirmed by the NICHQ Vanderbilt Assessment Scales-Parent and be fluent in English. Participants can continue their current ADHD treatments but cannot change them during the study.
What is being tested?
The trial tests Intermittent Theta Burst Stimulation to the Left Dorsolateral Prefrontal Cortex on teens with ADHD. It aims to see if this non-invasive brain stimulation can improve symptoms by affecting brain activity related to attention and impulsivity.
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort at the stimulation site, headache, lightheadedness or seizures; however these are generally rare with non-invasive brain stimulation techniques.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ adhd/working memory symptoms will be obtained before the 1st session, and 24 hours after the 1st, 5th, and 10th sessions. statistical modeling will examine the change across these time points. this change is considered a single primary outcome variable.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~adhd/working memory symptoms will be obtained before the 1st session, and 24 hours after the 1st, 5th, and 10th sessions. statistical modeling will examine the change across these time points. this change is considered a single primary outcome variable.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Parent-Reported ADHD & Working Memory-Related Symptoms
Change in Theta-Gamma Coupling
Change in Working Memory Test Performance
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active intermittent Theta Burst StimulationActive Control1 Intervention
Participants will complete 10 daily sessions of active iTBS to the left dorsolateral prefrontal cortex
Group II: Sham intermittent Theta Burst StimulationPlacebo Group1 Intervention
Participants will complete 10 daily sessions of sham iTBS to the left dorsolateral prefrontal cortex
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Who is running the clinical trial?
Bradley HospitalLead Sponsor
17 Previous Clinical Trials
1,536 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
295 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a pacemaker.Your IQ (intelligence quotient) should be higher than 80.You have a deep brain stimulator device implanted.You have a neurological disorder that is getting worse over time, like a disease that affects your brain or nerves.You have a history of seizures or epilepsy, or someone in your immediate family has epilepsy.You have a device called a medication pump implanted in your body.You have a vagal nerve stimulator implanted in your body.You have a TENS unit implanted in your body, unless it is completely removed for the study.You have had a head injury that caused you to be unconscious for a long time.You are currently experiencing severe mental health issues like hallucinations or extreme mood swings.You are currently feeling like you want to harm yourself.You have a major problem with your vision, hearing, or ability to speak.You are showing signs of pressure building up inside your head.You have been dependent on drugs or alcohol in the past six months.You have a known genetic disorder or acquired neurological condition that affects your brain, such as NF1 or stroke. You also have a history of severe head injury or significant physical abnormalities.You have a history of fainting spells that doctors aren't sure about, and they think it might be related to seizures.You have a ventriculo-peritoneal shunt.You have long-term medical conditions that are not well controlled and could lead to a medical emergency if you have a seizure. Examples include heart problems, irregular heartbeats, and severe asthma.
Research Study Groups:
This trial has the following groups:- Group 1: Sham intermittent Theta Burst Stimulation
- Group 2: Active intermittent Theta Burst Stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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