What side effects are associated with this type of intervention?

Common treatments for ADHD include medications such as stimulants (e.g., methylphenidate and amphetamines) and non-stimulants (e.g., atomoxetine and guanfacine), as well as neuromodulation techniques like repetitive transcranial magnetic stimulation (rTMS). Stimulant medications can cause side effects such as insomnia, decreased appetite, weight loss, increased heart rate, and potential for abuse. Non-stimulants may lead to side effects like fatigue, nausea, and mood swings. rTMS, which is being studied for its potential to improve working memory in ADHD, is generally well-tolerated but can cause mild side effects such as headaches, scalp discomfort, and lightheadedness.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, including stimulants like methylphenidate and amphetamines, and non-stimulants like atomoxetine and guanfacine. While these medications primarily target neurotransmitter systems to improve attention and reduce hyperactivity, neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) are still under investigation and have not yet received FDA approval for ADHD treatment. rTMS aims to modulate neuronal activity to enhance cognitive functions like working memory, which is a focus of ongoing clinical trials.

What other types of research exist?

Promising, novel alternatives to rTMS for ADHD patients include transcutaneous supraorbital nerve stimulation and remote electrical neuromodulation. Both methods have shown efficacy in reducing pain intensity in migraine patients, suggesting potential for modulating neuronal activity in ADHD. Additionally, noninvasive vagus nerve stimulation (nVNS) has shown benefits in treating episodic migraine and may offer similar advantages for ADHD.

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Non-invasive Brain Stimulation

Brain Stimulation for ADHD-Related Working Memory Deficits

N/A

Waitlist Available

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

Must not have

History of fainting spells of unknown or undetermined etiology that might constitute seizures

Signs of increased intracranial pressure

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

No Placebo-Only Group

Summary

This trial tests whether magnetic pulse therapy can improve memory in teenagers with ADHD and healthy young adults by enhancing brain wave interactions.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had fainting spells that might be seizures.

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I am experiencing symptoms of high pressure inside my skull.

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I have a worsening neurological condition.

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I have a brain condition due to genetics (like NF1) or an event (like a stroke).

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I have a major issue with my vision, hearing, or speech.

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I have a brain lesion found on an MRI.

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I have a history of seizures or epilepsy, or a close family member does.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Theta-Gamma Coupling After Sham iTBS

Change in Theta-Gamma Coupling after Active iTBS

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ADHD include stimulant medications like methylphenidate and amphetamines, which increase the levels of dopamine and norepinephrine in the brain, enhancing attention and focus. Non-stimulant medications, such as atomoxetine, work by selectively inhibiting the reuptake of norepinephrine. Repetitive Transcranial Magnetic Stimulation (rTMS) is an emerging treatment that modulates neuronal activity by using magnetic fields to stimulate specific brain regions, potentially improving working memory and executive function. These mechanisms are crucial for ADHD patients as they directly target the neurobiological underpinnings of the disorder, helping to alleviate core symptoms and improve daily functioning.

Enhancing attention in neurodegenerative diseases: current therapies and future directions.[Attention deficit hyperactivity disorder and mental retardation].Repetitive transcranial magnetic stimulation (rTMS): new tool, new therapy and new hope for ADHD.