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

Stopped early · Not applicable

Conditions studied: Mild to Moderate Depression

In brief

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.

Key facts

Study ID

NCT03471754

Run by

Annecto LLC

People needed

12

Starts

2017-09-26

Expected to finish

2019-01-31

Last updated by the study team

2019-02-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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