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

Mild to Moderate Depression Clinical Trial

— TESAHBPilot  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03471754
• Other study ID #: TESAHB64-17
• Status: Terminated
• Phase: N/A
• Start date: September 26, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: February 2019
• Source: Annecto LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Mild to Moderate Depression

Intervention

Device:
• TESA-HB Transcranial Electronic Stimulation Device
Duration of treatment: 50 Minute Therapy sessions administered one time each day, for two 5-day cycles

Locations

Country	Name	City	State
United States	Holy Redeemer Health Care at Bensalem, 3300 Tillman Drive	Bensalem	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Annecto LLC	Holy Redeemer Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Montgomery-Asberg Depression Rating Scale (MADRS)	Will be analyzed in total score	Statistically significant improvement from baseline to end of study period (4 months)
Secondary	Major Depression Inventory (MDI)	Will be analyzed in total score	Statistically significant improvement from baseline to end of study period (4 months)
Secondary	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)
Secondary	Beck's Depression Inventory (BDI)	Will be analyzed in total score	Statistically significant improvement from baseline to end of study period (4 months)
Secondary	Beck's Anxiety Inventory (BAI)	Will be analyzed in total score	Statistically significant improvement from baseline to end of study period (4 months)
Secondary	Hamilton Anxiety Rating Scale (HAM-A)	Will be analyzed in total score	Statistically significant improvement from baseline to end of study period (4 months)
Secondary	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)