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

This is an interventional treatment trial for Mild to Moderate Depression focused on measuring Depression, transcranial electronic stimulation, pilot, open label, safety, efficacy Read More

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