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Trial record 69 of 2660 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03471754
Recruitment Status : Terminated (Administrative reasons, and did not meet sample size requirements)
First Posted : March 21, 2018
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
Holy Redeemer Hospital
Information provided by (Responsible Party):
Annecto LLC

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.

Condition or disease Intervention/treatment Phase
Mild to Moderate Depression Device: TESA-HB Transcranial Electronic Stimulation Device Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot, Open Label, single center trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Using Transcranial Electrostimulation (TESA-HB) Therapy for the Treatment of Depressive Symptoms Associated With Mild to Moderate Depressive Episodes
Actual Study Start Date : September 26, 2017
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. Major Depression Inventory (MDI) [ Time Frame: Statistically significant improvement from baseline to end of study period (4 months) ]
    Will be analyzed in total score

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471754


Locations
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United States, Pennsylvania
Holy Redeemer Health Care at Bensalem, 3300 Tillman Drive
Bensalem, Pennsylvania, United States, 19020
Sponsors and Collaborators
Annecto LLC
Holy Redeemer Hospital
Investigators
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Principal Investigator: Beth DuPree, MD, MD Holy Redeemer Hospital
Study Director: Yakov Katsnelson, MD Annecto LLC

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Responsible Party: Annecto LLC
ClinicalTrials.gov Identifier: NCT03471754     History of Changes
Other Study ID Numbers: TESAHB64-17
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Annecto LLC:
Depression, transcranial electronic stimulation, pilot, open label, safety, efficacy

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms