Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19

January 11, 2023 updated by: Prof. Dr. Andreas Rembert Koczulla, Schön Klinik Berchtesgadener Land

Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19 - a Randomised Controlled Pilot Study

The aim of the study is to investigate the effect of cranial electrotherapy stimulation (CES), for one hour a day over 3 weeks pulmonary rehabilitation (PR) program on symptoms of anxiety in post-Covid patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Many patients recovering from Covid-19 develop sequelae related to the disease. In addition to lung issues, symptoms of Post-Covid/Long-Covid Syndrome include fatigue, brain fog, amyosthenia, insomnia, anxiety and depression. These symptoms play a major role in post-Covid patients recovery.

CES (Cranial electrotherapy stimulation) is a non-invasive therapy using low intensity alternating current applied through electrodes attached to the ear lobe.

CES has been used to improve the condition of non covid patients suffering from depression, anxiety, fatigue and cognitive disabilities. This is thought to be due to a change in electric waves of the brain with an increase of alpha-waves and a decrease of beta- and delta-waves, as well as a change of concentration of neurotransmitters, e.g. beta-endorphin or serotonin.

Therefore, this study aims to investigate the effect of CES in addition to normal PR, compared to PR alone on symptoms (e.g. anxiety) in post-Covid patients.

Hypothesis: Three weeks of PR including daily use of CES for one hour will have a positive effect on symptoms of anxiety.

Trial: 40 patients post-Covid reffered to inpatient PR will be recruited and allocated to one of two different groups. Group1: Anxious participants, Group 2: Non anxious participants. Within groups particpants will be randomized to intervention or control/sham. Intervention group will be using a functional device, and the other using a non-functional, SHAM device.

Anxiety is evaluated using the Beck anxiety inventory on admission and at discharge from PR.

Questionnaires to evaluate fatigue, depression and insomnia are the Fatigue Assessment Scale, PHQ-9, PSQI).

A diary will be kept by each participant with a log of general health and mood over the PR program.

Study Type

Interventional

Enrollment (Actual)

40

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

  • Germany
    • Bavaria
      • Schönau Am Königssee, Bavaria, Germany, 83471
        • Klinikum Berchtesgadener Land, Schön Kliniken

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Group with anxiety:

  • high Beck Anxiety Inventory Score
  • ≥18 years
  • post SARS-CoV-2 infection
  • written consent

Group without anxiety:

  • low Beck Anxiety Inventory Score
  • ≥18 years
  • post SARS-CoV-2 infection
  • written consent

Exclusion Criteria:

  • acitve implants (cardiac pacemaker,...)
  • pregnancy, lactation period

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Post-Covid patients, anxious, functional device
Applitation of 100µA CES for one hour per day to anxious patients
Device: Application of CES via ear clips
Use of 100µA CES for one hour per day over PR program
Placebo Comparator: Post-Covid patients, anxious, Sham
Use of Sham CES for one hour per day by anxious patients
Device: Sham: No application of CES via ear clips
Use of Sham CES for one hour per day over PR programm
Active Comparator: Post-Covid patients, non anxious, functional device
Application of 100µA CES for one hour per day to non anxious patients
Device: Application of CES via ear clips
Use of 100µA CES for one hour per day over PR program
Placebo Comparator: Post-Covid patients, non anxious, Sham
Use of Sham CES for one hour per day by non anxious patients
Device: Sham: No application of CES via ear clips
Use of Sham CES for one hour per day over PR programm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of symptoms of anxiety during intervention
Time Frame: Day 1 and Day 21
Comparison of the Beck Anxiety Inventory pre and post pulmonary rehabilitation
Day 1 and Day 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in insomnia during intervention
Time Frame: Day 1 and Day 21
Comparison of the PSQI questionnaire pre and post pulmonary rehabilitation
Day 1 and Day 21
Change in fatigue during intervention
Time Frame: Day 1 and Day 21
Comparison of the FAS questionnaire pre and post pulmonary rehabilitation
Day 1 and Day 21
Change in depression during intervention
Time Frame: Day 1 and Day 21
Comparison of the PHQ-9 questionnaire pre and post pulmonary rehabilitation
Day 1 and Day 21
Change of general condition/ perceived well-being of the patient
Time Frame: Day 1 until Day 21
Evaluation of the diary kept by the patient
Day 1 until Day 21
Subjective effectiveness of device
Time Frame: Day 21
Evaluation of the diary kept by the patient
Day 21
Comfort while using the device
Time Frame: Day 21
Evaluation of the diary kept by the patient
Day 21

Collaborators and Investigators

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

Sponsor

Schön Klinik Berchtesgadener Land

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 (Actual)

November 19, 2021

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AlphaStim

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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