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

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.

Study Overview

• Status: Terminated
• Conditions: Mild to Moderate Depression
• Intervention / Treatment: Device: TESA-HB Transcranial Electronic Stimulation Device

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Bensalem, Pennsylvania, United States, 19020
      • Holy Redeemer Health Care at Bensalem, 3300 Tillman Drive

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm A; TESA-HB Device, Mode 3 (15mA). Treatment arm involves two 5-day treatment cycles over a 2-week period, with 2 days off between each of the 5-day cycles. The treatment period will as for two full weeks.	Device: TESA-HB Transcranial Electronic Stimulation Device; Duration of treatment: 50 Minute Therapy sessions administered one time each day, for two 5-day cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Rating Scale (HAM-D21)	The HAM-D21 will be analyzed as a single measure result	Statistically significant improvement from baseline to end of study period (4 months)
Medication Usage Log	Will be used in total, as a covariate in analysis of primary outcome	Statistically significant improvement from baseline to end of study period (4 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)	Will be analyzed in total score	Statistically significant improvement from baseline to end of study period (4 months)
Major Depression Inventory (MDI)	Will be analyzed in total score	Statistically significant improvement from baseline to end of study period (4 months)
The Psychological General Well-Being Index (PGWB-S)	Will be analyzed in total score	Statistically significant improvement from baseline to end of study period (4 months)
Beck's Depression Inventory (BDI)	Will be analyzed in total score	Statistically significant improvement from baseline to end of study period (4 months)
Beck's Anxiety Inventory (BAI)	Will be analyzed in total score	Statistically significant improvement from baseline to end of study period (4 months)
Hamilton Anxiety Rating Scale (HAM-A)	Will be analyzed in total score	Statistically significant improvement from baseline to end of study period (4 months)
Medication Usage Log (MUL)	Will be analyzed in total score, with no covariate	Statistically significant improvement from baseline to end of study period (4 months)

Collaborators and Investigators

• Sponsor: Annecto LLC
• Collaborators: Holy Redeemer Hospital
• Investigators: Principal Investigator: Beth DuPree, MD, MD, Holy Redeemer Hospital; Study Director: Yakov Katsnelson, MD, Annecto LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2017
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 21, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Depression, transcranial electronic stimulation, pilot, open label, safety, efficacy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: TESAHB64-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes