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Spinal Cord Stimulation for the Treatment of Major Depressive Disorder

NCT ID: NCT03433339

Last Updated: 2024-12-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-29

Study Completion Date

2022-09-13

Brief Summary

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

Detailed Description

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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

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Major Depressive Disorder

Keywords

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depression transcutaneous spinal direct current stimulation non-invasive major depressive disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

8-week, double blinded, randomized, sham controlled, parallel group, pilot clinical trial study design.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
An independent operator (trained personnel from the research team) will prepare the tsDCS device parameters for each session, but will not participate in the rest of the assessments. Patients and raters will remain blinded to spinal stimulation protocol assigned to each participant throughout the study.

Study Groups

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Active Treatment

Thoracic anodal transcutaneous spinal direct current stimulation 2.5 milliampere (mA) for 20 min/ three times per week for 8 weeks.

Group Type EXPERIMENTAL

Active transcutaneous spinal direct current stimulation

Intervention Type DEVICE

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

Sham Treatment

Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks.

Group Type SHAM_COMPARATOR

Sham transcutaneous spinal direct current stimulation

Intervention Type DEVICE

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

Interventions

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Active transcutaneous spinal direct current stimulation

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

Intervention Type DEVICE

Sham transcutaneous spinal direct current stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lindner Center of HOPE

OTHER

Sponsor Role collaborator

Brain & Behavior Research Foundation

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Francisco Romo-Nava

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francisco Romo-Nava, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati/ Lindner Center of HOPE

Locations

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Lindner Center of HOPE/University of Cincinnati

Mason, Ohio, United States

Site Status

Countries

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United States

References

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Romo-Nava F, Awosika OO, Basu I, Blom TJ, Welge J, Datta A, Guillen A, Guerdjikova AI, Fleck DE, Georgiev G, Mori N, Patino LR, DelBello MP, McNamara RK, Buijs RM, Frye MA, McElroy SL. Effect of non-invasive spinal cord stimulation in unmedicated adults with major depressive disorder: a pilot randomized controlled trial and induced current flow pattern. Mol Psychiatry. 2024 Mar;29(3):580-589. doi: 10.1038/s41380-023-02349-9. Epub 2023 Dec 20.

Reference Type DERIVED
PMID: 38123726 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SPIDEP 2017-7424

Identifier Type: -

Identifier Source: org_study_id