An Study of Transcranial Direct Current Stimulation in Adults With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02640651
• Other study ID #: 2014P001728
• Status: Suspended
• Phase: N/A
• Start date: December 2015
• Est. completion date: August 2020

Study information

• Verified date: August 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

Device:
• DC-Stimulator (PLUS version)
transcranial direct current stimulation

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)	Assesses levels of executive function deficits	Baseline to 2 weeks
Primary	Cambridge Neuropsychological Test Automated Battery (CANTAB)	A computer-based system designed to assess executive functioning	Baseline to 2 weeks