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

Schön Klinik Berchtesgadener Land

Status: Completed

Conditions: POST-Covid 19; Anxiety

Treatments: Device: Application of CES via ear clips; Device: Sham: No application of CES via ear clips

Study type: Interventional

Funder types: Other

Identifiers

NCT05126511

AlphaStim

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 4 patient groups, including a placebo group

Post-Covid patients, anxious, functional device

Active Comparator group

Description:

Applitation of 100µA CES for one hour per day to anxious patients

Treatment:

Device: Application of CES via ear clips

Post-Covid patients, anxious, Sham

Placebo Comparator group

Description:

Use of Sham CES for one hour per day by anxious patients

Treatment:

Device: Sham: No application of CES via ear clips

Post-Covid patients, non anxious, functional device

Active Comparator group

Description:

Application of 100µA CES for one hour per day to non anxious patients

Treatment:

Device: Application of CES via ear clips

Post-Covid patients, non anxious, Sham

Placebo Comparator group

Description:

Use of Sham CES for one hour per day by non anxious patients

Treatment:

Device: Sham: No application of CES via ear clips