Plain English Summary
Background and study aims
Neurofeedback (EEG [electroencephalography] biofeedback) is a non-invasive method to regulate brain activity by biological feedback. In simple terms, the device monitors the EEG and gives the subject information (e.g. visual) about how "good" the EEG is. When the brain receives immediate and accurate information about the EEG, it can, after a short training, learn how to improve the EEG. Neurofeedback has been proven by a number of scientific studies to be a successful method for improving learning, attention, memory, motor function, sleep disorders, and other neurological conditions. Neurological post-COVID syndrome includes complications such as dizziness, seizures, fatigue, insomnia, depression, anxiety and migraines. The aim of this study is to determine if neurofeedback could be a treatment for the rehabilitation of neurological post-COVID symptoms.
Who can participate?
Patients aged 18 years and over who have had COVID-19 and suffer from at least one of the following neurological symptoms: insomnia, migraines/headaches, dizziness, seizures, fatigue, depression and anxiety
What does the study involve?
Participation involves an initial interview (medical history), completion of questionnaires about the medical condition of the participants, and five 30-minute neurofeedback sessions. Questionnaires are completed before neurofeedback and immediately after, 1 week after and 1 month after the neurofeedback sessions.
What are the possible benefits and risks of participating?
Participants may improve their post-COVID symptoms. Regarding the potential risks of participation, participants might experience some temporary side effects of neurofeedback, such as headaches or fatigue, which may occur during neurofeedback training and/or several hours after termination of the neurofeedback session.
Where is the study run from?
Charles University in Prague (Czech Republic)
When is the study starting and how long it is expected to run for?
June 2021 to December 2021
Who is funding the study?
Charles University in Prague (Czech Republic)
Who is the main contact?
Mária Orendáčová
maria.orendacova@lf3.cuni.cz
Study website
Contact information
Type
Public
Contact name
Miss Mária Orendáčová
ORCID ID
Contact details
Ruska 87
Prague
10000
Czech Republic
+421 (0)904851743
maria.orendacova@lf3.cuni.cz
Type
Scientific
Contact name
Miss Mária Orendáčová
ORCID ID
Contact details
Zvoníčková
Praha 6
16000
Czech Republic
+421 (0)904851743
maria.orendacova@lf3.cuni.cz
Type
Principal Investigator
Contact name
Miss Mária Orendáčová
ORCID ID
Contact details
Zvoníčková
Praha 6
16000
Czech Republic
+421 (0)904851743
maria.orendacova@lf3.cuni.cz
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
In adults suffering from post-COVID complications is neurofeedback therapy effective, when comparing conditions before and after the intervention, in reducing the severity of these complications?
Acronym
PCOVIDNE
Study hypothesis
1. Five sessions of neurofeedback (NFB) will significantly reduce post-COVID-19 seizures, dizziness, insomnia, headaches/migraines, fatigue, anxiety, and depression
2. NFB-induced significant improvement in the above post-COVID-19 symptoms will be present 1 week after NFB
3. NFB-induced significant improvement in the above post-COVID-19 symptoms will persist after 1 month after NFB
4. There will be a positive correlation between post-COVID fatigue, anxiety and depression
5. Improvements in fatigue, anxiety and depression will be correlated
Ethics approval(s)
Approved 16/07/2021, Ethics Committee of Third Faculty of Medicine, Charles University (Prague 87 Ruská, Prague, 100 00, Czechia; +420 (0)26710 2915; marek.vacha@lf3.cuni), ref: none provided
Study design
Single-center interventional open-label non-randomized clinical trial
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Post-COVID complications
Intervention
The aim of this pilot control clinical trial is to investigate the effect of neurofeedback therapy (Othmer method) on fatigue, anxiety, and depression after COVID-19. For measuring the severity of post-COVID-19 fatigue, anxiety, and depression, standardized medical questionnaires are used before, immediately after, 1 week after and 1 month after termination of neurofeedback therapy. Five 25-minute sessions of neurofeedback therapy are administrated within 2 weeks.
Intervention type
Device
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Neurofeedback (Deymed Diagnostics, version 11)
Primary outcome measure
1. Fatigue measured using the Fatigue Assessment Scale at baseline, immediately, 1 week and 1 month after neurofeedback
2. Anxiety measured using the Beck Anxiety Inventory at baseline, immediately, 1 week and 1 month after neurofeedback
3. Depression measured using the Beck Depression Inventory (version 2) at baseline, immediately, 1 week and 1 month after neurofeedback
4. Dizziness measured using the Dizziness Handicap Inventory at baseline, immediately, 1 week and 1 month after neurofeedback
5. Seizures are measured using the Seizure Severity Questionnaire at baseline, immediately, 1 week and 1 month after neurofeedback
6. Migraines/headaches measured using the Headache Disability Index at baseline, immediately, 1 week and 1 month after neurofeedback
7. Insomnia measured using the Insomnia Severity Index at baseline, immediately, 1 week and 1 month after neurofeedback
Secondary outcome measures
Measured using Visual Analogue Scales at baseline, immediately, one week and one month after neurofeedback:
1. Mood swings
2. Memory and attention problems
Overall study start date
01/06/2021
Overall study end date
22/12/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18-65 years
2. A positive history of SARS‑CoV‑2 infection confirmed by a positive antigen/reverse transcription polymerase chain reaction (RT-PCR)/antibody test
3. At least one of the following symptoms: insomnia, headaches/migraines, dizziness, seizures, fatigue, depression, and anxiety that were not present prior to SARS‑CoV‑2 infection
4. The specific symptoms should have been present or persisted for at least 3 months after confirmed SARS‑CoV‑2 infection and should not have been attributable to any other neurological disease prior to COVID-19
5. Being free of neurological/systemic health problems prior to SARS‑CoV‑2
6. Being medication-free (or medically stable in type and dosage of the drug for at least 3 months prior to neurofeedback experiment)
Participant type(s)
Other
Age group
Adult
Lower age limit
18 Years
Upper age limit
65 Years
Sex
Both
Target number of participants
10
Total final enrolment
17
Participant exclusion criteria
1. Younger than 18 years
2. No positive anamnesis of SARS‑CoV‑2 infection confirmed by positive antigen/RT-PCR/antibody test
3. Absence of post-COVID complications
4. The presence of neurological/systemic disorders prior to SARS‑CoV‑2 infection
Recruitment start date
01/08/2021
Recruitment end date
02/11/2021
Locations
Countries of recruitment
Czech Republic
Study participating centre
Third Faculty of Medicine, Charles University in Prague,
Ruska 87
Prague
10000
Czech Republic
Sponsor information
Organisation
Charles University
Sponsor details
Ovocný trh 560/5
Prague
116 36
Czech Republic
+420 (0)224 491 111
sekretariat@ruk.cuni.cz
Sponsor type
University/education
Website
http://www.cuni.cz/UKENG-1.html
ROR
Funders
Funder type
University/education
Funder name
Univerzita Karlova v Praze
Alternative name(s)
Charles University, Charles University in Prague, Univerzita Karlova, Karls-Universität zu Prag, UK
Funding Body Type
government organisation
Funding Body Subtype
Universities (academic only)
Location
Czech Republic
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
Intention to publish date
06/06/2022
Individual participant data (IPD) sharing plan
The data-sharing plans for the current study are unknown and will be made available at a later date.
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 27/07/2022 | 28/07/2022 | Yes | No | |
| Protocol file | 06/10/2022 | No | No |