Neuromodulation of Executive Function in the ADHD Brain

Mass General Brigham

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Device: Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04175028

2014P001401

Details and patient eligibility

About

This study aims to determine the transient, modulatory effects of transcranial direct current stimulation (tDCS) on executive function and inhibitory control in patients with ADHD compared to healthy controls.

Full description

This study aims to determine the transient, modulatory effects of transcranial direct current stimulation (tDCS) on executive function and inhibitory control in patients with ADHD. Deficits in these cognitive functions are core to ADHD, and cause significant impairment and morbidity. The study will also include a cohort of healthy controls for comparison.

Enrollment: 83 patients

Sex: All

Ages: 18 to 66 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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83 participants in 2 patient groups

ADHD

Other group

Description:

Patients with ADHD.

Treatment:

Device: Transcranial Direct Current Stimulation

Healthy Control

Other group

Description:

Volunteers without Neuropsychiatric Disorders.

Treatment:

Device: Transcranial Direct Current Stimulation