Spinal Cord Stimulation for the Treatment of Major Depressive Disorder

University of Cincinnati20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Major Depressive Disorder

Interventions

Active transcutaneous spinal direct current stimulationDEVICE

Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.

Sham transcutaneous spinal direct current stimulationDEVICE

Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. age 18-55 yrs., inclusive 2. female or male 3. Body mass index (BMI) 18.5 to 35 kg/mts2, inclusive 4. current MDD episode diagnoses confirmed by Mini International Neuropsychiatric Interview (MINI) 5.0 with a duration of ≥1 month and ≤24 months 5. moderate MDD symptoms according to Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20 to ≤35 6. no current or recent (past month) antidepressant pharmacological treatment 7. Generalized anxiety disorder (GAD) and other anxiety symptoms will be permitted 8. using an effective contraceptive method (all participants of childbearing potential). Exclusion criteria: 1. Current or lifetime MDD episode non-responsive to two or more antidepressant treatments at adequate doses and time (including ECT) 2. Current or lifetime bipolar disorder or schizophrenia diagnosis 3. current (past month): PTSD, psychotic or substance use disorder (nicotine and caffeine allowed) 4. significant risk of suicide according to Columbia Suicide Severity Rating Scale (CSSRS) or clinical judgment, or suicidal behavior in the past year 5. current chronic severe pain conditions 6. current chronic use of: opioids analgesics, medications that affect blood pressure or drugs with significant autonomic effects (stimulants and antipsychotics allowed if dose stable for 1 month) 7. neurological, endocrinological, cardiovascular (including diagnosed hypertension) or other clinically significant medical conditions as judged by the clinician 8. skin lesions on electrode placement region 9. implanted electrical medical devices 10. Pregnancy 11. suspected Intellectual quotient (IQ)\<80 12. any other clinically relevant reason as judged by the clinician.

Locations (1)

Lindner Center of HOPE/University of Cincinnati

Mason, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks (or last available observation).

Secondary Outcomes

Number of Participants With Skin Redness

Number of participants with skin redness in the active and sham tsDCS groups.

Time frame: 8 weeks

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.

Time frame: 8 weeks

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.

Time frame: 8 weeks

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.

Time frame: 8 weeks

Multidimensional Assessment of Interoceptive Awareness (MAIA) Score Change-Noticing Subscale

Data from ClinicalTrials.gov

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