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.
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: 1. Three tDCS sessions applied once every other day. 2. Three tDCS sessions applied once every third day. 3. Three tDCS sessions applied once every fourth day.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
34
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.
Healthcare Innovations Institute, LLC
Coral Springs, Florida, United States
Oceane7 Medical & Research Center, Inc.
Miami, Florida, United States
Renew Health Clinical Research, LLC
Snellville, Georgia, United States
Conrad Clinical Research
Edmond, Oklahoma, United States
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
Time frame: 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
Time frame: 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
Time frame: From baseline to 4-week follow up across study subjects
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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: From baseline to the end of week 4 of treatment, and to the end of week 8 of treatment.