Post-COVID fatigue Infections and Infestations
Conditions
Interventions
In this study, participants will be required to self-administer electrical stimulation to the external ear to activate nerves running beneath the surface of the skin. A FlexiStim (TensCare, Epsom, UK)
or research team member) will set up the stimulation parameters for the TENS device and train the participant to use the device at the end of their visit to the laboratory, after completing laboratory
Sponsors
Newcastle University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Members of the public (adults) who have a verifiable positive COVID diagnosis (COVID+) but who did not require hospitalisation and who are at least 4 weeks after diagnosis, will be recruited via the trial website (http://covidfatigue.org.uk/), social media and radio advertisements. They will be screened for symptoms of fatigue using an electronic implementation of the Fatigue Impact Scale 2. Aged =18 and <65 years 3. Able to provide written informed consent in English 4. No previous diagnosis of neurological or psychiatric disorder 5. No cardiac disease (e.g., cardiomyopathy, myocardial infarction, arrhythmia, prolonged QT interval, etc) 6. No implanted device (e.g., pacemaker) 7. Not pregnant 8. Fluent in English
Exclusion criteria
Exclusion criteria: 1. Previous diagnosis of neurological or psychiatric disorder 2. Cardiac disease (e.g., cardiomyopathy, myocardial infarction, arrhythmia, prolonged QT interval, etc) 3. Implanted device (e.g., pacemaker) 4. Pregnant 5. Not fluent in English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue assessed using a visual analogue scale (VAS) at Week 1, Week 2, Week 4, Week 8, Week 12, Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ongoing levels of fatigue (Fatigue Impact Scale [FIS], Functional Assessment of Chronic Illness Therapy – Fatigue [FACIT-F], VAS), mood (Generalised Anxiety Disorder Assessment [GAD-7], Patient Health Questionnaire [PHQ-9]) and musculoskeletal pain (Brief Pain Inventory), measured with questionnaires at Week 1, Week 2, Week 4, Week 8, Week 12, Week 16 2. Biometric data measured using wearable technology (Axivity AX6 & Vitalpatch) for 7 days at each of the three assessment periods (Week 1, Week 8, Week 16) 3. Maximal M-wave measured by median nerve stimulation from the abductor pollicis brevis muscle at Week 1, Week 8, Week 16 4. Intracortical inhibitory circuits assessed by measuring motor evoked potentials elicited via transcranial magnetic stimulation (TMS) during recruitment curves, paired-pulse and short-interval intracortical inhibition paradigms at Week 1, Week 8, Week 16 5. Grip force measured with a handgrip dynamometer at Week 1, Week 8, Week 16 6. Galvanic skin responses measured by placing two metal plates on the lateral and medial surfaces of the index finger at Week 1, Week 8, Week 16 7. Reaction time measured using a StartReact paradigm and measure stop-signal reaction time at Week 1, Week 8, Week 16 8. Heart rate and its variability measured with single-channel ECG at Week 1, Week 8, Week 16 9. Molecular biomarkers measured using serum PAXgene RNA samples at Week 1, Week 8, Week 16 | — |
Countries
England, United Kingdom
Contacts
Public ContactMaria Germann
Outcome results
None listed