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