An Study of Transcranial Direct Current Stimulation in Adults With ADHD

NCT02640651 | Suspended

• 1 other identifier: 2014P001728
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to determine whether transcranial direct current stimulation safely and effectively improves symptoms of ADHD.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

DC-Stimulator (PLUS version)

EXPERIMENTAL

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)

Interventions

DC-Stimulator (PLUS version) DEVICE

transcranial direct current stimulation

DC-Stimulator (PLUS version)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Craig Surman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: December 29, 2015
• Study Start: December 1, 2015
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

US (1)