A Dose-Response Study of the Cognitive and Physiological Effects of tDCS to the DLPFC
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 Transcranial Direct Current Stimulation
Eligibility Criteria
Inclusion Criteria (Patients)
- Male and female outpatients 18-55 years of age
- A diagnosis of ADD/ADHD or meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- 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)).
- If on non-stimulant medications, dose must have been stable for at least 4 weeks.
Exclusion Criteria (Patients)
- Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
- Active substance dependence (except for tobacco).
- Pregnant or nursing females.
- Inability to participate in testing procedures.
Inclusion Criteria (Healthy Control)
1. Male and female outpatients 18-55 years of age
Exclusion Criteria (Healthy Control)
- Diagnosis of psychiatric of neurological disorder
- Ongoing treatment with any psychotropic medications.
- Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
- Active substance dependence (except for tobacco).
- Pregnant or nursing females.
- Inability to participate in testing procedures.
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
Measured using Eriksen Flanker Task (EFT)
Secondary Outcome Measures
Amplitude of Electroencephalogram (EEG) Event Related Potentials
Measure of amplitude related to stimulus
Full Information
NCT ID
NCT04175041
First Posted
November 18, 2019
Last Updated
July 21, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04175041
Brief Title
A Dose-Response Study of the Cognitive and Physiological Effects of tDCS to the DLPFC
Official Title
A Dose-Response Study of the Cognitive and Physiological Effects of tDCS to the DLPFC
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2019 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (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
To determine the cognitive and neurophysiological dose-response relationships of anodal tDCS to the left DLPFC as a function of absolute current intensity, individualized E-field intensity, and stimulation duration.
Detailed Description
To determine the cognitive and neurophysiological dose-response relationships of anodal tDCS to the left DLPFC as a function of absolute current intensity, individualized E-field intensity, and stimulation duration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Transcranial Direct Current Stimulation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (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
Measured using Eriksen Flanker Task (EFT)
Time Frame
Change Before and After Stimulation on Each of the Four Visits, Average of 2-6 Weeks
Secondary Outcome Measure Information:
Title
Amplitude of Electroencephalogram (EEG) Event Related Potentials
Description
Measure of amplitude related to stimulus
Time Frame
Change Before and After Stimulation on Each of the Four Visits, Average of 2-6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (Patients)
Male and female outpatients 18-55 years of age
A diagnosis of ADD/ADHD or meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
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)).
If on non-stimulant medications, dose must have been stable for at least 4 weeks.
Exclusion Criteria (Patients)
Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
Active substance dependence (except for tobacco).
Pregnant or nursing females.
Inability to participate in testing procedures.
Inclusion Criteria (Healthy Control)
1. Male and female outpatients 18-55 years of age
Exclusion Criteria (Healthy Control)
Diagnosis of psychiatric of neurological disorder
Ongoing treatment with any psychotropic medications.
Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
Active substance dependence (except for tobacco).
Pregnant or nursing females.
Inability to participate in testing procedures.
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
Learn more about this trial
A Dose-Response Study of the Cognitive and Physiological Effects of tDCS to the DLPFC
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