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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05126511
• Other study ID #: AlphaStim
• Status: Completed
• Phase: N/A
• Start date: November 19, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: January 2023
• Source: Schön Klinik Berchtesgadener Land
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• COVID-19

Intervention

Device:
• Application of CES via ear clips
Use of 100µA CES for one hour per day over PR program
• Sham: No application of CES via ear clips
Use of Sham CES for one hour per day over PR programm

Locations

Country	Name	City	State
Germany	Klinikum Berchtesgadener Land, Schön Kliniken	Schönau Am Königssee	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Schön Klinik Berchtesgadener Land

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of symptoms of anxiety during intervention	Comparison of the Beck Anxiety Inventory pre and post pulmonary rehabilitation	Day 1 and Day 21
Secondary	Change in insomnia during intervention	Comparison of the PSQI questionnaire pre and post pulmonary rehabilitation	Day 1 and Day 21
Secondary	Change in fatigue during intervention	Comparison of the FAS questionnaire pre and post pulmonary rehabilitation	Day 1 and Day 21
Secondary	Change in depression during intervention	Comparison of the PHQ-9 questionnaire pre and post pulmonary rehabilitation	Day 1 and Day 21
Secondary	Change of general condition/ perceived well-being of the patient	Evaluation of the diary kept by the patient	Day 1 until Day 21
Secondary	Subjective effectiveness of device	Evaluation of the diary kept by the patient	Day 21
Secondary	Comfort while using the device	Evaluation of the diary kept by the patient	Day 21