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

NCT03471754 | Terminated FDA Device

• 1 other identifier: TESAHB64-17
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild to Moderate Depression

Keywords

Depression, transcranial electronic stimulation, pilot, open label, safety, efficacy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  Statistically significant improvement from baseline to end of study period (4 months)

• Major Depression Inventory (MDI)

  Statistically significant improvement from baseline to end of study period (4 months)

• The Psychological General Well-Being Index (PGWB-S)

  Statistically significant improvement from baseline to end of study period (4 months)

• Beck's Depression Inventory (BDI)

  Statistically significant improvement from baseline to end of study period (4 months)

• Beck's Anxiety Inventory (BAI)

  Statistically significant improvement from baseline to end of study period (4 months)

Study Arms (1)

Treatment Arm A

EXPERIMENTAL

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

Interventions

TESA-HB Transcranial Electronic Stimulation Device DEVICE

Duration of treatment: 50 Minute Therapy sessions administered one time each day, for two 5-day cycles

Treatment Arm A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Annecto LLC: lead
• Holy Redeemer Hospital: collaborator

Study Sites (1)

Holy Redeemer Health Care at Bensalem, 3300 Tillman Drive

Bensalem, Pennsylvania, 19020, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Beth DuPree, MD, MD

  Holy Redeemer Hospital

  PRINCIPAL INVESTIGATOR

• Yakov Katsnelson, MD

  Annecto LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot, Open Label, single center trial

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 21, 2018
• Study Start: September 26, 2017
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: February 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)