Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Emotion Recognition Task Scores Change (Exploratory) |
Emotion recognition task scores change from baseline to week 8 (or last available observation) |
8 weeks |
|
Other |
Stop Signal Task Scores Change (Exploratory) |
Stop signal task scores change from baseline to week 8 (or last available observation) |
8 weeks |
|
Primary |
Montgomery Asberg Depression Rating Scale (MADRS) Score Change |
Difference in change from baseline to week 8 (or last available observation) in Montgomery Asberg Depression Rating Scale summed total scores scores between active and sham transcutaneous spinal direct current stimulation (tsDCS) groups. Scores range from 0 to 60, with higher scores indicating worse depressive symptom severity. |
8 weeks (or last available observation). |
|
Secondary |
Number of Participants With Skin Redness |
Number of participants with skin redness in the active and sham tsDCS groups. |
8 weeks |
|
Secondary |
Clinical Global Impression-Improvement (CGI-I) |
Clinical Global Impression-Improvement (CGI-I) scale score at week 8 (or last available information) difference between Active and Sham tsDCS groups. Range is from 1 to 7 with lower scores indicating better outcome. |
8 weeks |
|
Secondary |
Montgomery Asberg Depression Rating Scale (MADRS) Sub-component Score (Item 2) Change |
MADRS Item 2 score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. MADRS Item 2 (Reported sadness) scores range from 0 to 6 and a higher score indicates a worse severity. |
8 weeks |
|
Secondary |
Patient Health Questionnaire-9 (PHQ-9) Score Change |
PHQ-9 score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Scores range from 0 to 27, with higher scores indicating worse severity. |
8 weeks |
|
Secondary |
Multidimensional Assessment of Interoceptive Awareness (MAIA) Score Change-Noticing Subscale |
MAIA Noticing subscale score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Noticing Subscale scores range 0 to 5 and higher scores indicate better outcomes. |
8 weeks |
|
Secondary |
Binge Eating Scale (BES) Score Change |
BES score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Scores range from 0 to 46, with higher scores indicating a worse outcome. |
8 weeks |
|
Secondary |
Four-Dimensional Symptom Questionnaire (4-DSQ)- Somatization Dimension Score Change |
4-DSQ Somatization dimension score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Somatization scale scores range from 0 to 32, with higher scores indicating a worse outcome. |
8 weeks |
|
Secondary |
Systolic Blood Pressure Score Change |
Systolic Blood Pressure score change in mmHg from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Normal range is considered below 140 mmHg. A greater decrease from baseline to week 8 in mmHg is considered favorable. |
8 weeks |
|
Secondary |
Heart Rate Score Change |
Heart Rate score change in beats per minute (BPM) from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Normal BPM is considered between 60 to 100. A decrease in value is considered favorable. |
8 weeks |
|
Secondary |
Body Mass Index Change |
Body mass index (BMI) change in kg/mts2 from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Normal range is 18 to 25 kg/mt2. A decrease in value is considered favorable. |
8 weeks |
|
Secondary |
Adiponectin Level Change |
Adiponectin level change (in ug/mL) from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. No normative levels available. Decreased levels are considered favorable in the context of the study. |
8 weeks |
|
Secondary |
Leptin Level Change |
Leptin level (in ng/ml) change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Usual normal range 4.7 - 23.7 ng/ML. Decreased levels are considered favorable. |
8 weeks |
|
Secondary |
Cortisol Level Change |
Cortisol level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Typical afternoon levels may range 5-10 nmol/L. Decreased levels are considered favorable outcomes. |
8 weeks |
|
Secondary |
Insulin Level Change |
Insulin level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Fasting range typically 16-166 Milli-international Units Per Liter (mIU/L). Decreased levels are considered a favorable outcome. |
8 weeks |
|
Secondary |
Fibroblast Growth Factor-21 (FGF-21) Level Change |
Fibroblast growth factor-21 (FGF-21) level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Levels in ng/ml. No normative range established. Decreased levels are considered favorable in the context of the study. |
8 weeks |
|
Secondary |
Fatty Acid (LCn-3) Level Change |
Fatty Acid (LCn-3) level percentage change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Results reported on Erythrocyte eicosapentaenoic acid + docosahexaenoic acid (EPA+DHA) percentage change. Increase in EPA+DHA would indicate a better outcome. |
8 weeks |
|