COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN10942585

Monika Klírová

monika.klirova@nudz.cz

2022-05-06

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Long covid

1. Male and female outpatients aged 18-75 years with a history of COVID-19 and monitored by an outpatient physician for mental disorders (anxiety, mood disorders, sleep) within the PASC 2. PCR RNA SARS-CoV-2 negativity at screening/study entry 3. Duration of symptoms >1 and =18 months after detection of COVID-19 4. The mental ability to understand and sign the Informed Consent Form 5. Presence of neuropsychiatric PASC symptoms as determined by A-PASC with a minimum overall score =25 (cognitive score, emotional and functional impairment) 6. FIS questionnaire score =40 7. Psychopharmacological medication (if used) at a stable dose =4 weeks.

1. Contraindications of tDCS (skin disease, superficial injury, and fracture or infraction of skull in the stimulation area, epilepsy, metallic plates in the head) 2. History of any other DSM-IV axis I diagnosis prior to COVID-19, except for: 2.1. Depressive disorders, anxiety disorders, and sleep disorders that may be present in the history, but with at least 6 months of documented remission of symptoms 2.2. Disorders associated with the use of addictive substances at least 6 months before entering the study 3. Pregnancy or breastfeeding 4. Patients with severe and/or unstable somatic disorders (cardiovascular disease, neoplasms, endocrinology disorders, etc) 5. Patients suffering from a serious neurological disorder (eg epilepsy, head injury with loss of consciousness)

2

Czech Health Research Council

18

75

Czech Republic

Patients recovered from covid

N/A

34

Czech version of the “Fatigue Impact Scale“ (FIS) score after the acute phase of the study and after the 4W-FU

Not reported

[{"arm_notes": "", "treatment_id": 2484, "treatment_name": "Anodal tdcs", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]