Electrical Brain Stimulation at Home with the FLOW Device for the Treatment of Fatigue in Individuals with Post-COVID Syndrome.

Zusammenfassung der Studie

Your participation in the study includes a total of 5 visits to the clinic. 1. Pre-examination During the pre-examination (first appointment), you will be informed about the study and it will be checked whether you are eligible to participate. Within 2 weeks after the first appointment, the so-called screening (second appointment) follows: here, the study participants are first randomly assigned to one of the 2 groups (Group A or Group B). For the clear and understandable presentation of the study visits, the patient information is based solely on the sequence of visits as planned for Group A. This allows for a uniform and comprehensible description of the study process, as the visits for both groups are the same in content and only differ in the order of interventions. After the assignment, various tests and questionnaires will be conducted. 2. Treatment phase (for four weeks) Then, the first phase of the study begins. Group A starts with the four-week stimulation at home. This takes place five days a week, once daily for 30 minutes. To support the effect of the stimulation, it is recommended to engage in a light activity during the session (e.g., listening to music, watching TV, doing puzzles). During this phase, you will fill out a diary daily (duration: max. 5 minutes). 3. Tests after the treatment phase After the treatment phase, we will repeat the tests and questionnaires that were also conducted at the beginning of the study. 4. Usual treatments In the next four weeks, there will be no further treatment or tests. During this time, you will continue your usual therapies. 5. Tests and questionnaires after the four weeks without treatment. 6. Final examination The tests and questionnaires will be repeated after four weeks.

(BASEC)

Untersuchte Intervention

The planned intervention involves the application of low-intensity electrical brain stimulation (called transcranial direct current stimulation = tDCS) using the FLOW device. This involves anodic stimulation of the left dorsolateral prefrontal cortex (DLPFC) with a current strength of 2 milliamperes (mA). A total of 20 stimulation sessions are planned, which will take place over a period of four weeks. The self-administered stimulation occurs 5 days a week, each for 30 minutes. The stimulation is carried out independently by the participants in their home environment. Before the intervention begins, all participants receive a detailed instruction on how to operate the device, including written instructions and, if necessary, technical support from the study team. The self-application is designed to be safe, standardized, and practical for the participants.

(BASEC)

Untersuchte Krankheit(en)

Post-COVID Syndrome

(BASEC)

Sponsor

REHAB Basel

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

(BASEC)

Datum der Bewilligung durch die Ethikkommission

05.02.2026

(BASEC)

Ergebnisse der Studie