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| Name | Class |
|---|---|
| Lindner Center of HOPE | OTHER |
| Brain & Behavior Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Experimental | Thoracic anodal transcutaneous spinal direct current stimulation 2.5 milliampere (mA) for 20 min/ three times per week for 8 weeks. |
|
| Sham Treatment | Sham Comparator | Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active transcutaneous spinal direct current stimulation | Device | Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Skin Redness | Number of participants with skin redness in the active and sham tsDCS groups. | 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Romo-Nava, MD,PhD | University of Cincinnati/ Lindner Center of HOPE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lindner Center of HOPE/University of Cincinnati | Mason | Ohio | 45040 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38123726 | Derived | 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. |
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A plan for individual participant data is not included in the current protocol. Following Federal, State and Institutional regulations, data could be shared with other researchers after the study ends.
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Pre-screened 671 participants. Forty two were assessed for eligibility on site. A total of 22 were excluded for not meeting eligibility criteria (n=19) or declined to participate (n=3). A total of 20 participants were randomized.
All study procedures involving participants were conducted at the Lindner Center of HOPE (affiliated with the University of Cincinnati) in Mason, Ohio, with a recruitment period from August 29, 2018, to September 13, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment | Thoracic anodal transcutaneous spinal direct current stimulation 2.5 milliampere (mA) for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder. |
| FG001 | Sham Treatment | Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Although 10 participants were randomized on each arm, one participant on the Sham group withdrew after only completing the baseline visit and was excluded from the analysis. Baseline and longitudinal results analyze 10 participants on the active group and 9 on the sham group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment | Thoracic anodal transcutaneous spinal direct current stimulation 2.5 milliampere (mA) for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants with at least one post baseline Montgomery Asberg Depression Rating Scale total scores assessment were included in the analysis. | Posted | Least Squares Mean | Standard Error | summed total scores | 8 weeks (or last available observation). |
|
During the eight week study duration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Treatment | Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety/Panic symptoms | Nervous system disorders | Non-systematic Assessment |
This is a proof of concept pilot feasibility clinical trial with a small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francisco Romo-Nava | Lindner Center of HOPE/ University of Cincinnati Department of Psychiatry and Behavioral Neurosciences | 513-536-0725 | romofo@ucmail.uc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2023 | Feb 23, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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8-week, double blinded, randomized, sham controlled, parallel group, pilot clinical trial study design.
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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.
| Sham transcutaneous spinal direct current stimulation | Device | Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder. |
|
| 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. | 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. | 8 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Withdrawal by Subject |
|
| Sham Treatment |
Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Montgomery Asberg Depression Rating Scale (MADRS) Score | Montgomery Asberg Depression Rating Scale (MADRS) score at baseline. Scores range between 0 to 60. Higher scores indicate a worse severity of symptoms. | Mean | Standard Deviation | summed total scores |
|
| OG001 | Sham Treatment | Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder. |
|
|
|
| Secondary | Number of Participants With Skin Redness | Number of participants with skin redness in the active and sham tsDCS groups. | Posted | Count of Participants | Participants | 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. | Posted | Least Squares Mean | Standard Error | total score of the scale | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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. | Posted | Least Squares Mean | Standard Error | mmHg | 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. | Posted | Least Squares Mean | Standard Error | Beats per minute | 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. | Posted | Least Squares Mean | Standard Error | kg/m^2 | 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. | Posted | Least Squares Mean | Standard Error | ug/mL | 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. | Posted | Least Squares Mean | Standard Error | ng/mL | 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. | Posted | Least Squares Mean | Standard Error | nmol/L | 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. | Posted | Least Squares Mean | Standard Error | Milli-international Units/ Liter (mIU/L) | 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. | Posted | Least Squares Mean | Standard Error | ng/ml | 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. | Posted | Least Squares Mean | Standard Error | Percentage change | 8 weeks |
|
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 10 |
| 10 |
| EG001 | Sham Treatment | Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder. | 0 | 9 | 0 | 9 | 9 | 9 |
| Asymptomatic decrease in heart rate | Cardiac disorders | Non-systematic Assessment |
|
| Itching/Burnign sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Cold-like symptoms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| COVID-19 | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| External Ear Infection | Infections and infestations | Non-systematic Assessment |
|
| Friction Blister in Feet | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Prickling Sensation | Nervous system disorders | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Skin abrasion | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Skin redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Electrode site, transient. |
|
| Vaginities | Reproductive system and breast disorders | Non-systematic Assessment |
|
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| D001519 |
| Behavior |