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Non-invasive Brain Stimulation
Active intermittent Theta Burst Stimulation for Attention Deficit Hyperactivity Disorder (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 will test if a non-invasive brain stimulation can help improve symptoms for adolescents with ADHD by changing how the brain works.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
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)
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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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