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

February 1, 2019 updated by: Annecto LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hamilton Depression Rating Scale (HAM-D21)
Time Frame: Statistically significant improvement from baseline to end of study period (4 months)
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
Time Frame: Statistically significant improvement from baseline to end of study period (4 months)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Statistically significant improvement from baseline to end of study period (4 months)
Will be analyzed in total score
Statistically significant improvement from baseline to end of study period (4 months)
Major Depression Inventory (MDI)
Time Frame: Statistically significant improvement from baseline to end of study period (4 months)
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)
Time Frame: Statistically significant improvement from baseline to end of study period (4 months)
Will be analyzed in total score
Statistically significant improvement from baseline to end of study period (4 months)
Beck's Depression Inventory (BDI)
Time Frame: Statistically significant improvement from baseline to end of study period (4 months)
Will be analyzed in total score
Statistically significant improvement from baseline to end of study period (4 months)
Beck's Anxiety Inventory (BAI)
Time Frame: Statistically significant improvement from baseline to end of study period (4 months)
Will be analyzed in total score
Statistically significant improvement from baseline to end of study period (4 months)
Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: Statistically significant improvement from baseline to end of study period (4 months)
Will be analyzed in total score
Statistically significant improvement from baseline to end of study period (4 months)
Medication Usage Log (MUL)
Time Frame: Statistically significant improvement from baseline to end of study period (4 months)
Will be analyzed in total score, with no covariate
Statistically significant improvement from baseline to end of study period (4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Annecto LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Holy Redeemer Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Beth DuPree, MD, MD, Holy Redeemer Hospital
  • Study Director: Yakov Katsnelson, MD, Annecto LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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