Electrical Brain Stimulation at Home with the FLOW Device for the Treatment of Fatigue in Individuals with Post-COVID Syndrome.
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
Post-COVID Syndrome
(BASEC)
- Adult individuals ≥ 18 years old at the time of obtaining informed consent. - Post-COVID diagnosis (after acute infection, maximum 24 months old). - Fatigue Scale (FSS): A total score of ≥5 indicating significant fatigue. (BASEC)
Criteri di esclusione
- Other diagnosed conditions associated with fatigue (e.g., pre-existing Chronic Fatigue Syndrome, Multiple Sclerosis). - Presence of a brain pacemaker or intracerebral metal implants (electrodes, plates, clips, VP-shunt, cochlear implant). - Pregnant or breastfeeding women. (BASEC)
Luogo dello studio
Basilea
(BASEC)
Sponsor
REHAB Basel
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
PD Dr. med. Margret Hund-Georgiadis
+41 61 325 00 06
m.hund@clutterrehab.chREHAB Basel, Klinik für Neurorehabilitation und Paraplegiologie
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
05.02.2026
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Heimbasierte transkranielle Gleichstromstimulation mittels FLOW- Geräts zur Behandlung von Fatigue bei Personen mit Post-COVID- Syndrom. (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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non disponibile
Endpoint primari e secondari
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non disponibile
Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
non disponibile
Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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