Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2mA transcranial direct current stimulation | Experimental |
| |
| 1mA transcranial direct current stimulation | Experimental |
| |
| Sham transcranial direct current stimulation | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 mA transcranial direct current stimulation (tDCS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 1 - Week 8 of Study |
| Global Assessment of Functioning (GAF) Scale | investigators will use GAF scale to assess the potential feasibility of at-home tDCS for future research. | Week 1 - Week 8 of Study |
| 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. | Week 1 - Week 8 of Study |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DNN Inbox | Contact | 6177265348 | mghdnn@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joan Camprodon, MD, PHD, MPH | MGB: Division of Neuropsychiatry and Neuromodulation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Charlestown | Massachusetts | 02129 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32327965 | Background | 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. |
Not provided
Not provided
There is no plan to make IPD for the current study available to other researchers.
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects will be randomized during the first study visit to the 2mA, 1mA, or sham conditions. Subjects will not change dose throughout study.
Not provided
Not provided
Soterix devices allow for effective and automated double-blinding.
|
| 1 mA transcranial direct current stimulation (tDCS) | Device | 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. |
|
| Sham transcranial direct current stimulation (tDCS) | Device | 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. |
|
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided