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An Study of Transcranial Direct Current Stimulation in Adults With ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DC-Stimulator (PLUS version)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DC-Stimulator (PLUS version)

Arm Description

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

Outcomes

Primary Outcome Measures

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.
Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Assesses levels of executive function deficits
Cambridge Neuropsychological Test Automated Battery (CANTAB)
A computer-based system designed to assess executive functioning

Secondary Outcome Measures

Full Information

First Posted
September 23, 2015
Last Updated
August 13, 2019
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02640651
Brief Title
An Study of Transcranial Direct Current Stimulation in Adults With ADHD
Official Title
An Open Label Pilot Study of Transcranial Direct Current Stimulation in Adults With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Suspended
Why Stopped
Lack of study staff
Study Start Date
December 2015 (undefined)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DC-Stimulator (PLUS version)
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
DC-Stimulator (PLUS version)
Intervention Description
transcranial direct current stimulation
Primary Outcome Measure Information:
Title
Adult ADHD Investigator Symptom Rating Scale (AISRS)
Description
Each of the individual DSM-V symptoms of ADHD is rated 0 to 3 on a scale of severity.
Time Frame
Baseline to 2 weeks
Title
Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Description
Assesses levels of executive function deficits
Time Frame
Baseline to 2 weeks
Title
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Description
A computer-based system designed to assess executive functioning
Time Frame
Baseline to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Surman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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An Study of Transcranial Direct Current Stimulation in Adults With ADHD

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