Modulating executive function in adults with ADHD using brain stimulation

Neuromodulation of Executive Function in the ADHD Brain

This study tests if a brain stimulation technique can help adults with ADHD improve their thinking skills and self-control compared to healthy individuals.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 66 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT04175028 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of transcranial direct current stimulation (tDCS) on executive function and inhibitory control in adults diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). By comparing the results with healthy controls, the study aims to understand how tDCS can transiently enhance cognitive functions that are typically impaired in ADHD. Participants will include both individuals with ADHD and healthy volunteers, with specific eligibility criteria regarding age and medication use. The study will assess the impact of tDCS on cognitive performance in a controlled setting.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-66 with a diagnosis of ADHD or healthy volunteers.

Not a fit: Patients who do not meet the diagnostic criteria for ADHD or are not within the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new non-pharmacological treatments for improving executive function in patients with ADHD.

How similar studies have performed: Other studies have shown promising results using tDCS for cognitive enhancement, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria

1. Male and female subjects 18-66 years of age
2. Healthy volunteers or volunteers with a diagnosis of ADHD in adulthood, meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) \[American Psychiatric Association, 2013\] criteria, including at least 5 moderate inattentive or impulsive-hyperactive symptoms, and onset of two symptoms of inattentive or of impulsive/hyperactive traits by the age of 12.
3. Patient will be either off stimulant medications or, if undergoing treatment with stimulants, will be asked to discontinue two days prior to the experiment, under physician-guided protocol, and allowed to resume afterwards. Subjects may resume stimulant use between the two study visits so long as they discontinue use two days prior to the second study visit. If fatigue is problematic in subjects discontinuing medication, they will be allowed to continue with the study if they are able to follow the suggested taper plan (50% of the dose day one, 25% dose day 2, stop day of visit (day 3)).
4. English-speaking

Exclusion Criteria

1. Current or past history of clinically unstable psychiatric conditions such as suicidal or homicidal behavior or psychotic disorders.
2. Pregnant or nursing females.
3. Inability to participate in testing procedures
4. Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
5. Additional exclusion criteria for healthy controls:

   1. Diagnosis of psychiatric of neurological disorder
   2. Ongoing treatment with any psychotropic medications.

Where this trial is running

Boston, Massachusetts

• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Joan Camprodon, MD, PhD, MPH — Massachusetts General Hospital
• Study coordinator: Joan Camprodon, MD, PhD, MPH

Conditions Attention Deficit Hyperactivity Disorder; Executive Function