What side effects are associated with this type of intervention?

Common treatments for ADHD include stimulant medications like methylphenidate and amphetamines, as well as non-stimulant medications such as atomoxetine. Stimulant medications can cause side effects such as insomnia, decreased appetite, weight loss, increased heart rate, and potential exacerbation of tics. Non-stimulant medications may cause side effects like fatigue, nausea, and mood swings. For neuromodulation treatments like tDCS, side effects are generally mild and may include skin irritation at the electrode site, headache, and dizziness. These treatments aim to modulate neuronal activity to improve cognitive control and reduce ADHD symptoms.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, primarily focusing on stimulant medications such as methylphenidate (e.g., Ritalin) and amphetamines (e.g., Adderall), which enhance neurotransmitter activity to improve attention and control impulsivity. Non-stimulant medications like atomoxetine (Strattera) and extended-release guanfacine (Intuniv) have also been approved, targeting different neurotransmitter systems to achieve similar outcomes. While these medications work through pharmacological means, transcranial Direct Current Stimulation (tDCS) represents a non-pharmacological approach by modulating neuronal activity directly through electrical stimulation, aiming to improve cognitive control and reduce ADHD symptoms.

What other types of research exist?

Promising novel alternatives to tDCS for ADHD treatment include repetitive Transcranial Magnetic Stimulation (rTMS) and Cranial Electrotherapy Stimulation (CES). rTMS has shown efficacy in modulating brain activity and improving symptoms in various psychiatric conditions, including ADHD. CES, which involves low-level electrical stimulation of the brain, has also demonstrated potential in improving mood and cognitive function in ADHD patients.

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Device

tDCS for ADHD

N/A

Recruiting

Led By Joan Camprodon, MD, PHD, MPH

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female outpatients 18-65 years of age

A diagnosis of ADD/ADHD or meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.

Must not have

Premorbid neurological conditions (including neurovascular and neurodegenerative diseases such as traumatic brain injury, stroke, Parkinson's, AD and other dementias) and severe psychiatric disorders (bipolar disorder, schizophrenia).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1 - week 8 of study

Summary

This trial is testing if home-based tDCS can help people with ADHD by using a small electrical current to improve brain function. It aims to make advanced treatments more accessible by allowing patients to use the therapy at home. Transcranial direct current stimulation (tDCS) has been studied for its potential to improve cognitive functions in ADHD, showing promise in enhancing attention, inhibitory control, and working memory.

Who is the study for?

This trial is for adults aged 18-65 with a diagnosis of ADHD according to DSM-5 criteria. It's not suitable for pregnant or nursing women, individuals with epilepsy, metallic head/neck implants, brain stimulators, pacemakers, active substance dependence (except tobacco), or severe psychiatric disorders like bipolar disorder and schizophrenia.

What is being tested?

The study tests if home-based tDCS can reduce ADHD symptoms and improve cognitive control over four weeks. Participants will receive either a low dose (1 mA), high dose (2 mA) of stimulation, or a sham treatment to compare effectiveness.

What are the potential side effects?

tDCS may cause mild side effects such as tingling at the electrode site, fatigue, headache, nausea or itching under the electrodes during application. Serious side effects are rare but could include seizures in susceptible individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have been diagnosed with ADD/ADHD.

Exclusion Criteria

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

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I have a history of serious brain conditions or severe mental health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1 - week 8 of study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1 - week 8 of study

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 - week 8 of study for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adult ADHD Self-Report Scale

Global Assessment of Functioning (GAF) Scale

P300 Amplitude during Erickson Flanker Task

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: 2mA transcranial direct current stimulationExperimental Treatment1 Intervention

Group II: 1mA transcranial direct current stimulationExperimental Treatment1 Intervention

Group III: Sham transcranial direct current stimulationPlacebo Group1 Intervention

0 / 3Eligibility 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 pharmacological and neuromodulation approaches. Stimulant medications like methylphenidate and amphetamines increase dopamine and norepinephrine levels, enhancing attention and reducing hyperactivity and impulsivity. Non-stimulant medications such as atomoxetine work by inhibiting norepinephrine reuptake. Neuromodulation techniques like transcranial Direct Current Stimulation (tDCS) apply a low electrical current to specific brain areas to modulate neuronal activity, improving cognitive control and reducing ADHD symptoms. Understanding these mechanisms helps tailor treatments to individual needs, potentially enhancing efficacy and minimizing side effects.

Transcranial direct current stimulation in attention-deficit/hyperactivity disorder: A meta-analysis of clinical efficacy outcomes.Transcranial direct current brain stimulation decreases impulsivity in ADHD.Transcranial direct current stimulation in attention-deficit hyperactivity disorder: A meta-analysis of neuropsychological deficits.