Neuromodulation of Executive Function in the ADHD Brain
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional other trial for Attention Deficit Hyperactivity Disorder focused on measuring Executive Function
Eligibility Criteria
Inclusion Criteria
- Male and female subjects 18-66 years of age
- 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.
- 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)).
- English-speaking
Exclusion Criteria
- Current or past history of clinically unstable psychiatric conditions such as suicidal or homicidal behavior or psychotic disorders.
- Pregnant or nursing females.
- Inability to participate in testing procedures
- Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
Additional exclusion criteria for healthy controls:
- Diagnosis of psychiatric of neurological disorder
- Ongoing treatment with any psychotropic medications.
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
ADHD
Healthy Control
Arm Description
Patients with ADHD.
Volunteers without Neuropsychiatric Disorders.
Outcomes
Primary Outcome Measures
Change in Accuracy and Reaction Time in Attention and Working Memory
N-Back Task
Change in Accuracy and Reaction Time in Attention and Working Memory
Flanker Task
Change in Accuracy and Reaction Time in Attention and Working Memory
Multi-Source Interference with International Affective Picture System Task
Change in Accuracy and Reaction Time in Inhibition/Decision Making
Delayed Discounting
Change in Accuracy and Reaction Time in Inhibition/Decision Making
Stop Signal Task
Change in Accuracy and Reaction Time in Inhibition/Decision Making
Cambridge Gambling Task
Secondary Outcome Measures
Amplitude of Encephalogram (EEG) Event Related Potentials
Measure of amplitude related to stimulus
Full Information
NCT ID
NCT04175028
First Posted
November 18, 2019
Last Updated
July 21, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04175028
Brief Title
Neuromodulation of Executive Function in the ADHD Brain
Official Title
Neuromodulation of Executive Function in the ADHD Brain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2014 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Executive Function
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ADHD
Arm Type
Other
Arm Description
Patients with ADHD.
Arm Title
Healthy Control
Arm Type
Other
Arm Description
Volunteers without Neuropsychiatric Disorders.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
Primary Outcome Measure Information:
Title
Change in Accuracy and Reaction Time in Attention and Working Memory
Description
N-Back Task
Time Frame
Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Title
Change in Accuracy and Reaction Time in Attention and Working Memory
Description
Flanker Task
Time Frame
Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Title
Change in Accuracy and Reaction Time in Attention and Working Memory
Description
Multi-Source Interference with International Affective Picture System Task
Time Frame
Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Title
Change in Accuracy and Reaction Time in Inhibition/Decision Making
Description
Delayed Discounting
Time Frame
Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Title
Change in Accuracy and Reaction Time in Inhibition/Decision Making
Description
Stop Signal Task
Time Frame
Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Title
Change in Accuracy and Reaction Time in Inhibition/Decision Making
Description
Cambridge Gambling Task
Time Frame
Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Secondary Outcome Measure Information:
Title
Amplitude of Encephalogram (EEG) Event Related Potentials
Description
Measure of amplitude related to stimulus
Time Frame
Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Male and female subjects 18-66 years of age
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.
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)).
English-speaking
Exclusion Criteria
Current or past history of clinically unstable psychiatric conditions such as suicidal or homicidal behavior or psychotic disorders.
Pregnant or nursing females.
Inability to participate in testing procedures
Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
Additional exclusion criteria for healthy controls:
Diagnosis of psychiatric of neurological disorder
Ongoing treatment with any psychotropic medications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joan Camprodon, MD, PhD, MPH
Phone
61772656348
Email
jcamprodon@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Cirillo, MD, PhD
Phone
6177243217
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Camprodon, MD, PhD, MPH
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
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blake Andreou, BS
Phone
617-724-8780
Email
bandreou@mgh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33549516
Citation
Dubreuil-Vall L, Gomez-Bernal F, Villegas AC, Cirillo P, Surman C, Ruffini G, Widge AS, Camprodon JA. Transcranial Direct Current Stimulation to the Left Dorsolateral Prefrontal Cortex Improves Cognitive Control in Patients With Attention-Deficit/Hyperactivity Disorder: A Randomized Behavioral and Neurophysiological Study. Biol Psychiatry Cogn Neurosci Neuroimaging. 2021 Apr;6(4):439-448. doi: 10.1016/j.bpsc.2020.11.006. Epub 2020 Nov 25.
Results Reference
derived
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Neuromodulation of Executive Function in the ADHD Brain
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