Identification of Specific Modulation Frequencies in Hepatitis B Carriers With and Without Hepatocellular Carcinoma (THBC-HSL2)

September 10, 2015 updated by: Frederico Perego Costa, Hospital Sirio-Libanes
The propose of this study is to identification of a group of specific amplitude-modulated frequencies of low intensity electromagnetic fields that is associated with biofeedback upon exposure to in patients with hepatitis B carries with or without hepatocellular carcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be exposed by different specific amplitude-modulated frequencies of low intensity electromagnetic fields for 30 min. During the exposure, autonomic response with be recorded in order to identify biofeedback response. Differences in group of frequencies is expected in patients with hepatitis B carries with or without hepatocellular carcinoma.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • 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

  • Brazil
      • São Paulo, Brazil, 01308-050
        • Hospital Sírio Libanês

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hepatitis B carriers patients
  • hepatitis B carriers patients with hepatocellular cancer patients

Exclusion Criteria:

  • other tumor types
  • other hepatitis types

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hepatitis
hepatitis B carriers patients
Device: Low intensity amplitude-moduled electromagnetic fields
Patients in each arm will be exposed to 30 min of amplitude-moduled low intensity electromagnetic fields only one time.
Other Names:
  • TheraBionic
  • OncoBionic P1
Experimental: hepatocellular carcinoma patients
hepatites B carriers patients with associated hepatocellular carcinoma
Device: Low intensity amplitude-moduled electromagnetic fields
Patients in each arm will be exposed to 30 min of amplitude-moduled low intensity electromagnetic fields only one time.
Other Names:
  • TheraBionic
  • OncoBionic P1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of different group of specific frequencies of modulation in hepatitis B carriers with and without hepatocellular carcinoma associated with biofeedback response
Time Frame: within 10 min of exposure
biofeedback response will be monitored
within 10 min of exposure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of differences biofeedback response in hepatitis B carriers with and without hepatocellular carcinoma
Time Frame: within 10 minutes of exposure
Representation of autonomous response during the exposure of specific frequencies of modulation
within 10 minutes of exposure

Collaborators and Investigators

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

Sponsor

Hospital Sirio-Libanes

Investigators

  • Principal Investigator: Frederico P Costa, MD, Hospital Sírio-Libanês

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

April 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 13, 2012

First Posted (Estimate)

July 16, 2012

Study Record Updates

Last Update Posted (Estimate)

September 14, 2015

Last Update Submitted That Met QC Criteria

September 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02621512.3.0000.5461

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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