Transcranial direct current stimulation (tDCS) in the treatment of neuropsychiatric symptoms of post-COVID syndrome (long COVID)
- Conditions
- Post-acute sequelae of SARS-CoV-2 infection (PASC)Mental and Behavioural Disorders
- Registration Number
- ISRCTN10942585
- Lead Sponsor
- Czech Health Research Council
- Brief Summary
2024 Results article in https://doi.org/10.1038/s41598-024-52763-4 (added 28/02/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 33
Current participant inclusion criteria as of 10/11/2023:
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 =24 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.
Previous participant inclusion criteria:
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current primary outcome measure as of 10/11/2023:<br>Czech version of the Fatigue Impact Scale (FIS) score after the acute phase of the study<br><br><br><br><br>Previous primary outcome measure:<br>Czech version of the Fatigue Impact Scale (FIS) score after the acute phase of the study and after the 4W-F
- Secondary Outcome Measures
Name Time Method