NCT03433339

Spinal Cord Stimulation for the Treatment of Major Depressive Disorder

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Active transcutaneous spinal direct current stimulation	Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
DEVICE	Sham transcutaneous spinal direct current stimulation	Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.

Timeline

• Start date: 2018-08-29
• Primary completion: 2022-09-13
• Completion: 2022-09-13
• First posted: 2018-02-14
• Last updated: 2024-12-27
• Results posted: 2024-04-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study