An Study of Transcranial Direct Current Stimulation in Adults With ADHD

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to determine whether transcranial direct current stimulation safely and effectively improves symptoms of ADHD.

Official Title
-----------------
An Open Label Pilot Study of Transcranial Direct Current Stimulation in Adults With ADHD

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Device: DC-Stimulator (PLUS version)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female adults 18-65 years of age. A diagnosis of childhood onset ADHD, 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 several symptoms of inattentive or of impulsive/hyperactive traits by the age of 12. English-speaking. Exclusion Criteria: - Current or past history of mental retardation, severe sensory impairment such as deafness or blindness, hypomania, mania, psychosis, suicidal or homicidal behavior. Current moderate to severe symptoms of a mental health condition other than ADHD, assessed using a clinical evaluation and the Adult Self Report Scale that, in the judgment of the investigator, may jeopardize subject safety or interfere with their ability to participate in the study. Specifically, this will include current clinical diagnosis of moderate to severe major depression, or a score on the depressive problem subscale of the ASRS that falls in the clinically significant range. Substance use disorder within the past 6 months. Any significant medical condition, that, in the judgment of the investigator, may jeopardize subject safety. Pregnant females. Inability or unwillingness to participate in study procedures. Contraindication to tDCS: history of epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, or pacemakers. Skin conditions that may make the application of, treatment with, and removal of the tDCS hardware painful as per the discretion of the clinician. Current use of a medication considered to be therapeutic for ADHD. If a subject is taking a medication that is considered by study investigators to potentially treat ADHD (eg. a stimulant, atomoxetine, buproprion, modafanil, serotonin-norepinephrine reuptake inhibitor, guanfacine or clonidine) they must stop use of this medication for at least 5 half lives of the drug under physician guidance prior to study participation. Subjects will not enter the study if it would require stopping a medication that is optimally and comfortably managing a clinical concern.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DC-Stimulator (PLUS version)<br>For tDCS stimulation, anodal stimulation of the right dorsolateral prefrontal cortex will be performed for twenty minutes at 2mA. The current will be applied by a battery-driven tDCS stimulator via a pair of saline-soaked sponge electrodes (25 cm2 surface). The anodal electrode will be placed on the scalp at the F4 position according to the international 10-20 EEG coordinate system. 20 minute tDCS sessions will be conducted ten times over a two week period | Device: DC-Stimulator (PLUS version)<br>* transcranial direct current stimulation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adult ADHD Investigator Symptom Rating Scale (AISRS) | Each of the individual DSM-V symptoms of ADHD is rated 0 to 3 on a scale of severity. | Baseline to 2 weeks | 
| Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) | Assesses levels of executive function deficits | Baseline to 2 weeks | 
| Cambridge Neuropsychological Test Automated Battery (CANTAB) | A computer-based system designed to assess executive functioning | Baseline to 2 weeks |