Spinal Cord Stimulation for the Treatment of Major Depressive Disorder

Phase 1

Completed

Conditions: Major Depressive Disorder

Interventions: Device: Sham transcutaneous spinal direct current stimulation
Device: Active transcutaneous spinal direct current stimulation

Registration Number: NCT03433339

Lead Sponsor: University of Cincinnati

Brief Summary: This pilot clinical trial will evaluate the efficacy and safety of transcutaneous direct current stimulation (tsDCS) in major depressive disorder.

Detailed Description: This study aims to 1) determine the efficacy and safety of tsDCS in adult patients with major depressive disorder (MDD) and 2) investigate interoceptive awareness, somatic symptoms, autonomic and metabolic regulation as potential mediators of antidepressant response to tsDCS. We predict that 1) Active tsDCS treatment will result in a greater decrease in depressive symptom severity compared to Sham tsDCS in adult patients with MDD, 2) active tsDCS will be safe and well tolerated in adult patients with MDD and 3) change in interoceptive awareness, somatic symptoms, and autonomic and metabolic parameters will be associated with change in depressive symptom severity. To accomplish these aims, we will conduct an 8-week, double blinded, randomized, sham controlled, parallel group, pilot clinical trial study design. A total of 20 adult antidepressant-free MDD patients will be randomized to receive Active (n=10) or Sham (n=10) tsDCS protocols for 8 weeks in a 1:1 ratio. We will combine the use of a tsDCS device, psychometric instruments to diagnose MDD, and measures of depressive symptom severity, somatic symptoms, interoceptive awareness, autonomic function (blood pressure, heart rate), and potential metabolic markers as predictors of response.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Treatment	Sham transcutaneous spinal direct current stimulation	Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks.
Active Treatment	Active transcutaneous spinal direct current stimulation	Thoracic anodal transcutaneous spinal direct current stimulation 2.5 milliampere (mA) for 20 min/ three times per week for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale (MADRS) Score Change	8 weeks (or last available observation).	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Skin Redness	8 weeks	Number of participants with skin redness in the active and sham tsDCS groups.
Clinical Global Impression-Improvement (CGI-I)	8 weeks	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.
Montgomery Asberg Depression Rating Scale (MADRS) Sub-component Score (Item 2) Change	8 weeks	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.
Patient Health Questionnaire-9 (PHQ-9) Score Change	8 weeks	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.
Multidimensional Assessment of Interoceptive Awareness (MAIA) Score Change-Noticing Subscale	8 weeks	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.
Binge Eating Scale (BES) Score Change	8 weeks	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.
Four-Dimensional Symptom Questionnaire (4-DSQ)- Somatization Dimension Score Change	8 weeks	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.
Heart Rate Score Change	8 weeks	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.
Body Mass Index Change	8 weeks	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.
Adiponectin Level Change	8 weeks	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.
Leptin Level Change	8 weeks	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.
Systolic Blood Pressure Score Change	8 weeks	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.
Cortisol Level Change	8 weeks	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.
Insulin Level Change	8 weeks	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.
Fibroblast Growth Factor-21 (FGF-21) Level Change	8 weeks	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.
Fatty Acid (LCn-3) Level Change	8 weeks	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.