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Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)

Primary Purpose

Attention Deficit Disorder, Attention Deficit Disorder With Hyperactivity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2 mA transcranial direct current stimulation (tDCS)
1 mA transcranial direct current stimulation (tDCS)
Sham transcranial direct current stimulation (tDCS)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder

Eligibility Criteria

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

Inclusion Criteria:

  1. Male and female outpatients 18-65 years of age
  2. A diagnosis of ADD/ADHD or meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.

Exclusion Criteria:

  1. Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
  2. Active substance dependence (except for tobacco).
  3. Pregnant or nursing females.
  4. Inability to participate in testing procedures.
  5. Premorbid neurological conditions (including neurovascular and neurodegenerative diseases such as traumatic brain injury, stroke, Parkinson's, AD and other dementias) and severe psychiatric disorders (bipolar disorder, schizophrenia).

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

2mA transcranial direct current stimulation

1mA transcranial direct current stimulation

Sham transcranial direct current stimulation

Arm Description

Outcomes

Primary Outcome Measures

P300 Amplitude during Erickson Flanker Task
P300, an electrophysiological feature theorized to represent executive functioning, has been previously shown to be notably diminished during the Erickson Flanker Task (EFT) . We will be administering this task to assess changes in P300 during the EFT, and if any changes are related to subjects' assigned condition.
Global Assessment of Functioning (GAF) Scale
investigators will use GAF scale to assess the potential feasibility of at-home tDCS for future research.
Adult ADHD Self-Report Scale
Investigators will assess changes to these questionnaires in reference to assigned stimulation group to assess changes to ADHD symptomatology across study duration.

Secondary Outcome Measures

Full Information

First Posted
April 7, 2022
Last Updated
March 21, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05354232
Brief Title
Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
Official Title
Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2025 (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
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
The investigators are investigating whether home-based tDCS over the course of four weeks can improve ADHD symptom severity and improve dysexecutive functioning (cognitive control). Further, the investigators are investigating whether there is a dose-dependent response to tDCS.
Detailed Description
This mechanistic clinical trial will be the first of its kind to assess the clinical and cognitive efficacy of tDCS, and its relationship to physiological target engagement. It will also provide critical knowledge about tDCS dosing in a therapeutic context (i.e. 30 days of daily tDCS). Last, it will assess the feasibility and acceptability of home-based neuromodulation therapies for ADHD, reducing the most significant obstacle for the implementation of devices therapies (i.e. daily visits to the hospital for several weeks) and facilitating access to advanced therapeutics to a large population of patients with ADHD. An additional goal of the proposed study is to assess the feasibility and acceptability of home-based neuromodulation therapies for ADHD, reducing the most significant obstacle for the implementation of devices therapies (i.e. daily visits to the hospital for several weeks) and facilitating access to advanced therapeutics to a large population of patients with ADHD.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized during the first study visit to the 2mA, 1mA, or sham conditions. Subjects will not change dose throughout study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Soterix devices allow for effective and automated double-blinding.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2mA transcranial direct current stimulation
Arm Type
Experimental
Arm Title
1mA transcranial direct current stimulation
Arm Type
Experimental
Arm Title
Sham transcranial direct current stimulation
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
2 mA transcranial direct current stimulation (tDCS)
Intervention Description
tDCS is a non-invasive neuromodulatory technique that has previously demonstrated the ability to transiently modulate cognitive domains in both healthy and psychiatric populations. In the 2mA condition, the investigators will assist the administration of a 2mA current stimulation from the device.
Intervention Type
Device
Intervention Name(s)
1 mA transcranial direct current stimulation (tDCS)
Intervention Description
tDCS is a non-invasive neuromodulatory technique that has previously demonstrated the ability to transiently modulate cognitive domains in both healthy and psychiatric populations. In the 1mA condition, the investigators will assist the administration of a 1mA current stimulation from the device.
Intervention Type
Device
Intervention Name(s)
Sham transcranial direct current stimulation (tDCS)
Intervention Description
tDCS is a non-invasive neuromodulatory technique that has previously demonstrated the ability to transiently modulate cognitive domains in both healthy and psychiatric populations. In the sham condition, the investigators will assist the administration of a sham stimulation from the device.
Primary Outcome Measure Information:
Title
P300 Amplitude during Erickson Flanker Task
Description
P300, an electrophysiological feature theorized to represent executive functioning, has been previously shown to be notably diminished during the Erickson Flanker Task (EFT) . We will be administering this task to assess changes in P300 during the EFT, and if any changes are related to subjects' assigned condition.
Time Frame
Week 1 - Week 8 of Study
Title
Global Assessment of Functioning (GAF) Scale
Description
investigators will use GAF scale to assess the potential feasibility of at-home tDCS for future research.
Time Frame
Week 1 - Week 8 of Study
Title
Adult ADHD Self-Report Scale
Description
Investigators will assess changes to these questionnaires in reference to assigned stimulation group to assess changes to ADHD symptomatology across study duration.
Time Frame
Week 1 - Week 8 of Study

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 outpatients 18-65 years of age A diagnosis of ADD/ADHD or meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Exclusion Criteria: 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. Premorbid neurological conditions (including neurovascular and neurodegenerative diseases such as traumatic brain injury, stroke, Parkinson's, AD and other dementias) and severe psychiatric disorders (bipolar disorder, schizophrenia).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DNN Inbox
Phone
6177265348
Email
mghdnn@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Camprodon, MD, PHD, MPH
Organizational Affiliation
MGB: Division of Neuropsychiatry and Neuromodulation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DNN Inbox
Phone
617-726-8780
Email
mghdnn@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD for the current study available to other researchers.
Citations:
PubMed Identifier
32327965
Citation
Dubreuil-Vall L, Ruffini G, Camprodon JA. Deep Learning Convolutional Neural Networks Discriminate Adult ADHD From Healthy Individuals on the Basis of Event-Related Spectral EEG. Front Neurosci. 2020 Apr 9;14:251. doi: 10.3389/fnins.2020.00251. eCollection 2020.
Results Reference
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Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)

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