Home-based tDCS in Major Depressive Disorder
Home-based tDCS in Major Depressive Disorder
The investigators propose a study of telehealth supervised, caregiver-delivered, home-based
 transcranial direct current stimulation (tDCS) for antidepressant treatment of patients with
 an acute depressive episode.
This is an open-label pilot feasibility telemedicine study. This pilot will involve a total
 of 37 stimulations sessions / at home visits (30- minute sessions of multichannel excitatory
 tDCS targeting the left DPFC) and the maintenance of a daily treatment diary to be completed
 by the subjects immediately after enrollment and 12 weeks following the last study visit.
Patients meeting one of the following criteria may be eligible to participate in this
 study.

 1. Patients with medication-resistant MDD who have undergone rTMS or ECT and responded to
 it but whose benefit has lapsed, and they need repeat a rTMS or ECT course that they
 cannot access

 2. Patients with medication-resistant MDD who have undergone rTMS or ECT and responded to
 it but whose benefit has lapsed, and they need repeat a rTMS or ECT course that they
 cannot access

 3. Patients with medication-resistant MDD who are undergoing rTMS or ECT and responding,
 but cannot continue to get the rTMS or ECT course due to COVID-19 pandemic-related
 regulations or other access concerns

 4. Patients with medication-resistant MDD who are referred to rTMS or ECT and are found
 well qualified but cannot access rTMS or ECT due to COVID-19 pandemic-related
 regulations or other access concerns.

 The benefits of this project address a present need due to the COVID-19 pandemic, but also
 go beyond the present situation and address a larger, pre-existing need. Across all these
 potential groups of participants, prospective participants will:

 -  need to have a primary psychiatrist who agrees to their participation in the study and
 is willing to continue to follow the patient and work collaboratively with the study
 team

 -  need to be assessed by their primary psychiatrist to be stable enough to be able to
 remain at home and participate in the present study without undue risk to their safety

 -  need to be living with an adult willing and capable to provide oversight and learn to
 deliver the home-based tDCS

 -  have the capability to connect with the study team for daily supervision of the
 intervention sessions and close safety monitoring, and be willing to commit to doing
 so

 Inclusion Criteria:

 Individuals with MDD

 Participants will be men and women who:

 -  Are aged 50 or older

 -  Able to read, write, and communicate in English

 -  Have a caregiver who is willing and able to provide the home tDCS sessions.

 -  Participants must be under the care of a treating psychiatrist who approves of the
 study participation and believes that TMS or ECT is indicated for his/her patient but
 that

 -  it would not endanger the patient to participate in the present study rather than
 pursue such alternative, or

 -  the patient could not gain access to TMS or ECT due to COVID-19 (The depression
 phase of bi-polar disorder is not a reason for exclusion if the treating
 psychiatrist believes TMS or ECT would be indicated).

 Participants with MDD must fit into one of the following 3 groups (medication-resistant MDD
 defined as 1) participant's condition has not responded to prescribed antidepressant
 medication; 2) participant is medication intolerant, or 3) some other underlying reason):

 -  Patients with medication-resistant Major depressive disorder (MDD) who have undergone
 repetitive transcranial magnetic stimulation (rTMS) or electroconvulsive therapy (ECT)
 and responded to it but whose benefit has lapsed and they need repeat rTMS or ECT
 course that they cannot access;

 -  Patients with medication-resistant MDD who are undergoing rTMS or ECT and responding,
 but cannot continue to get the rTMS or ECT course due to COVID-19 pandemic-related
 regulations or other access concerns

 -  Patients with medication-resistant MDD who are referred to rTMS or ECT and are found
 well qualified but cannot access rTMS or ECT due to COVID-19 pandemic-related
 regulations or other access concerns.

 Further, participants must:

 -  Meet criteria for a diagnosis of MDD according to the Diagnostic and Statistical
 Manual of Mental Disorders (DSM-IV-TR) (American Psychiatric Association, 2000), as
 determined via an tele-health interview with a study psychiatrist, and confirmed with
 the Mini International Neuropsychiatric Interview (MINI; Version 5.0.0) (Sheehan et
 al., 1998) and the prospective participant's primary psychiatrist.

 -  Currently experiencing a major depressive episode of at least four weeks' duration as
 part of a unipolar or bipolar depression. Score will need to be at least 20 on the
 MADRS.

 Participant caregiver-administrators:

 Caregiver-administrators will be men and women, who may be a spouse, family member or
 friend who is

 -  At least 21 years of age

 -  Able to read, write, and communicate in English

 -  Self-reported computer proficiency and willingness to learn how to use tDCS as defined
 by "yes" answers to the questions "Do you feel comfortable using a computer?" and "are
 you willing to learn

 -  How to administer tDCS?" Stated availability throughout the study period to administer
 tDCS sessions to the participant with MDD.

 Exclusion Criteria:

 -  Exclusion criteria for participants with MDD will be:

 -  Any DSM-psychotic disorder

 -  Drug or alcohol abuse or dependence in the preceding three months;

 -  Concurrent benzodiazepine medication;

 -  High suicide risk (Utilizing the Beck Depression Inventory and the Hamilton
 Depression Scale, suicide risk will be assessed at baseline by the study
 psychiatrist) ;

 -  History of clinically defined neurological disorder or insult; Metal in the
 cranium or skull defects;

 -  Skin lesions on the scalp at the proposed electrode sites;

 -  Pregnancy.

 -  Medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication
 infusion pump, cochlear implant, vagus nerve stimulator).

 -  Previous skull surgery with resultant skull defects

 -  Inability to understand study procedures following review of the Informed Consent
 form.

 Understanding will be assessed by asking the participant with MDD to answer the following
 three questions:

 1. What is the purpose of this study?

 2. What are the risks of study involvement?

 3. If you decide to participate, are you allowed to withdraw from the study at any time?
 Answers will be recorded by study personnel on the "Assessment of Protocol
 Understanding" form. Insufficient understanding will be defined by one or more
 incorrect answers, as determined at the discretion of the investigator.

 Exclusion criteria for Participant caregiver-administrators:

 -  Poor eyesight,

 -  Severe arthritis in the hands, pain, deformity or other condition that interferes with
 successful administration of tDCS.

 -  Inability to understand study procedures following review of the Informed Consent
 form.

 Understanding will be assessed by asking the participant caregiver-administrator to answer
 the following three questions:

 1. What is the purpose of this study?

 2. What are the risks of study involvement?

 3. If you decide to participate, are you allowed to withdraw from the study at any time?
 Answers will be recorded by study personnel on the "Assessment of Protocol
 Understanding" form (see attached). Insufficient understanding will be defined by one
 or more incorrect answers, as determined at the discretion of the investigator.