Home-based Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorders (MDD)

Study Overview
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Brief Summary
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This is an open label pilot feasibility telemedicine study. This pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session.

Detailed Description
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This is an open label pilot feasibility telemedicine study. This pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session. The main objective of the study is to assess the feasibility and safety of home-based tDCS for patients with MDD. The treatment course will consist of an acute phase of 28 tDCS sessions, conducted daily (7 days per week) over 4 weeks. Thereafter, participants will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows: Three tDCS sessions applied once every other day. Three tDCS sessions applied once every third day. Three tDCS sessions applied once every fourth day.

Official Title
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Home-based Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorders (MDD)

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: tDCS intervention applied by Starstim device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major Depressive Disorder Age >=18 Currently experiencing a major depressive episode of at least four weeks' duration MADRS score at least 20 at trial entry. Taking at least one approved antidepressant medication (except bupropion). Has a healthcare provider, and a companion who can help administer study treatments; and be able to connect frequently with study staff Access to wireless internet (wifi) connection Exclusion Criteria: Any psychotic disorder. Concurrent benzodiazepine medication. High suicide risk History of significant neurological disorder. Skin lesions on the scalp at the proposed electrode sites. Pregnancy. Any antidepressant medications will be permitted (except bupropion) provided the medication dose has been unchanged for 4 weeks prior to trial entry. Any cranial metal implants (excluding ≤1 mm thick epicranial titanium skull plates and dental fillings) or Medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagus nerve stimulator); Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm. Substance use disorder (including alcohol) within the past year.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>All patients will receive active treatment which consists of stimulation (tDCS) applied using the Starstim device, with current delivered via four Starstim Pi electrodes (circular electrodes with a contact of area of 3.14 cm2) embedded in the headpiece. All study subjects will use the same fixed montage (electrode locations and currents). | Device: tDCS intervention applied by Starstim device<br>* Stimulation will be applied using the Starstim device, with current delivered via four Starstim Pi electrodes (circular electrodes with a contact of area of 3.14 cm2) embedded in the headpiece. All study subjects will use the same fixed montage (electrode locations and currents). The montage has been designed to optimize anodal stimulation in the desired target area while avoiding stimulation off target.<br>* Other names: Starstim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of incomplete and missed sessions (%) | Feasibility will be evaluated using home-based data as recorded in the Neuroelectrics portal. Range [0,100]. Higher is worse | From baseline to 4-week follow up across study subjects | 
| Incidence of Serious Adverse Events (SAE) | Safety will be assessed by number and type of side effects | From baseline to 4-week follow up across study subjects | 
| Median percentage change in Montgomery-Asberg Depression Mood Rating Scale (MADRS) scores | The primary efficacy measure for this study will be the median percent change from baseline to the end of the 4-week post-treatment follow-up period in the observer-rated Montgomery-Asberg Depression Mood Rating Scale (MADRS) (Montgomery and Asberg, 1979). Range [0,100]. Higher is worse | From baseline to 4-week follow up across study subjects | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Response rate is the secondary efficacy endpoint and will be calculated for the study subjects, where clinical response is defined as ≥ 50% improvement in Montgomery-Asberg Depression Mood Rating Scale (MADRS) score. Higher is better | From baseline to the 4-week follow-up | 
| Change in the Quick Inventory of Depressive Symptomatology (QIDS-SR) score | Range [0,27]. Higher is worse | Change from baseline to 4-week follow-up in the participant-rated Quick Inventory of Depressive Symptomatology (QIDS-SR) | 
| Change in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) score | Range [14,70]. Higher is better | Change from baseline to 4-week follow-up in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) | 
| Median percentage change in Montgomery-Asberg Depression Mood Rating Scale (MADRS) scores |  | From baseline to the end of week 4 of treatment, and to the end of week 8 of treatment. |