Pilot Study Using Transcranial Electrostimulation (TESA-HB) Therapy for the Treatment of Depressive Symptoms

Pilot Study Using Transcranial Electrostimulation (TESA-HB) Therapy for the Treatment of Depressive Symptoms Associated With Mild to Moderate Depressive Episodes

This pilot study uses TESA-HB therapy for treatment of depressive symptoms associated with mild and moderate depression episodes. Primary objectives of this pilot study are to demonstrate the safety of TESA-HB Therapy, and to investigate the efficacy of TESA-HB Therapy for depressive symptoms.

The primary indicator variable in this study is the Hamilton Depression Rating Scale (HAM-D21), and secondary efficacy outcomes will be measured using:

• Major Depression Inventory
• Montgomery - Asberg Depression Rating Scale (MADRS)
• Beck's Depression Inventory
• Beck's Anxiety Inventory
• Hamilton Anxiety Rating Scale (HAM-A)
• The Psychological General Well-Being Index (PGWB-S)

The safety endpoints include:

• Medication Usage Log
• Adverse Event Log

Study Population includes men and women who are:

• Diagnosed with a mild to moderate depressive episode
• Have no recent history of taking antidepressant or anti-anxiety medication within 3 months prior to baseline

Inclusion Criteria:

• Between the ages of 18-65 years old on enrollment
• Assessed by Evaluator with mild to moderate depressive episode, based on the MDI Rating Scale (20-24 mild; 25-29 moderate).
• Have average MDI pain rating score of > 20 or <29 during baseline
• Assessed by Evaluator to have mild to moderate depressive episode, based on the HAM-D21 Rating Scale (8-13 = mild; 14-17 moderate).
• Assessed by Evaluator to have mild to moderate depressive episode based on ICD-10 Diagnostic Guidelines 1,2
• Willing and able to visit 2 weeks ( 5 times per week) as a clinic outpatient to participate in this clinical investigation
• Willing and able to return to the clinic for evaluation during the follow up period - 2 weeks, 1 month (4 wks), 2 months (8 wks), and 3 months (12wks) following the completion of TESA-HB Therapy
• Willing to be monitored, fill out daily medication logs, and appear for all physician visits for baseline, treatment and follow-up period
• English speaking and able to understand and approve the consent form, and understand and provide answers on the Depression and Anxiety assessment form and the Psychological General Well-Being Index (PGWB-S) questionnaires

Exclusion Criteria:• MDI Rating Scale of < 20 or > 29

• High variability in baseline MDI scores (changes more than 30%)
• HAM-D21 Rating Scale of < 8 or > 17
• Assessed outside of mild to moderate depression episode range based on the ICD-10 Diagnostic Guidelines 1,2
• Recent history of taking Antidepressant or Antianxiety medication within 3 months prior to baseline
• Is pregnant, or may be pregnant, or plans to become pregnant during the study period
• Sensitivity to electrodes and/or their conductive gels or adhesives
• Break in skin integrity at the areas of electrode placement
• Currently suspected use of narcotic
• Presence of any implanted electronic device, cardiac stimulator, or pacemaker
• History of brain injury, including seizures, epilepsy, stroke, tumor of central nervous system, or hydrocephalus
• Acute brain injuries, infections or tumor of central nervous system
• History of heart attacks within 1year congestive heart failure
• Blood pressure: > 140 systolic and/or > 90 diastolic
• History of schizophrenia
• Previous experience with Cranial Electrotherapy Stimulator (CES) devices
• Failure to complete 80% of daily medication logs or complete a questionnaire and two physician assessments during baseline period
• Failed to complete 75% of follow up visits or failed to complete more than 2 treatments will be excluded in the per-protocol (PP) analysis
• Acute psychiatric disorders (other than depression, insomnia and/or anxiety)
• Use of psychoactive drugs (other than antidepressants and/or anxiety)
• These subjects will continue to be followed in the study, but will be classified in the intent-to-treat (ITT) group
• HRHS employees, in an effort to protect their privacy, as the study will be conducted in a Holy Redeemer facility. Additionally, this exclusion was decided upon to minimize the possibility of coercion or undue influence in relationship with Holy Redeemer employees.
• Illiterate persons, as the study requires completion of assessments tools in the home setting where the subject may/may not have assistance with reading and understanding the tools, study documents and proceedures as required.
• Uninsured persons, to financially protect them in the rare instance that medical care would be required as a result of the study treatment