Transcranial Pulse Stimulation (TPS) in Post-COVID-19
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorMedical University of Vienna
About this trial
The objective of the present study is to demonstrate treatment efficacy of transcranial pulse stimulation for patients with Post-COVID-19 related neurological symptoms (fatigue, cognitive deficits, mood deterioration). Fatigue, as measured by the Fatigue Impact Scale (FIS), will represent the primary outcome variable. The verum treatment will be compared to a sham (placebo) condition.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed written informed consent
PCR-confirmed SARS-CoV-2 infection, laboratory confirmed antibody detection for SARS-CoV-2, or physician-verified COVID-19 infection
At least 12 months after initial SARS-CoV-2 infection that led to Post-COVID (subsequent SARS-CoV-2 infections are not a reason for exclusion)
Diagnosis of Post-COVID Syndrome or independent suspected diagnosis of Post-COVID Syndrome (Considering that physicians generally hesitate to provide clear-cut Post-COVID diagnoses, a tentative diagnosis by an independent general practitioner or a specialist in a field associated with Post-COVID will suffice for entering this study)
Disqualifiers
Clinically relevant realization of pre-COVID diseases with similar symptoms as Post-COVID
MoCA score <17 (cut-off for dementia)
BDI-II score ≥29 (cut-off for severe depression)
FIS <10 (cut-off for no fatigue)
Trial design
Design model
Parallel
Treatments tested in this trial
Transcranial pulse stimulation Verum
DeviceParticipants are slated to undergo a total of five TPS sessions over a 10-day interval. Each stimulation session will endure approximately 30 minutes and will be administered once daily.
Transcranial pulse stimulation Sham
DevicePlacebo treatment will be performed using the same medical device, handpiece and treatment paradigm as in the verum treatment with one difference: the standoff device at the end of the handpiece. This device is designed to replicate the appearance, feel, and sound of the verum system, while omitting the transmission of any pulses.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Verum TPSExperimental treatment 1 intervention
Group B: Sham TPSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fatigue Impact Scale (FIS)
The Fatigue Impact Scale (Fisk et al., 1994) is an instrument to measure the impact of fatigue symptoms. This self-report measure consists of 40 items divided into three subscales: cognitive functioning (10 items), physical functioning (10 items) and psychosocial functioning (20 items). In the validated German version, the statements are scored from 0-4 (0=never, 4=very often) leading to a total score of 0-160.
Time frame
Baseline - 1 week after stimulation - 1 month after stimulationSecondary outcomes
1
Beck Depression Inventory (BDI-II)
The Beck Depression Inventory (BDI-II) is one of the most widely used instruments for measuring the severity of depression. It is a 21-item questionnaire for self-evaluation with 0-3 scores per item, ranging from 0 (normal state) to 63 (severe depression).
Time frame
Baseline - 1 week after stimulation - 1 month after stimulation2
Montreal Cognitive Assessment (MOCA)
Montreal Cognitive Assessment (Nasreddine et al., 2005) is a clinical standard test for evaluating the following cognitive functions: visuospatial/executive, naming, memory, attention, language, abstraction, recall and orientation. The maximum score is 30 points.
Time frame
Baseline - 1 week after stimulation - 1 month after stimulation3
36-Item Short Form Health Survey (SF-36)
The 36-item short-form health survey (Ware et al., 1992) is a widely used instrument to measure quality of life. The 36-item patient-reported survey covers eight health concepts including physical functioning (10 items), role limitations due to physical health (4 items), role limitations due to emotional problems (3 items), energy/fatigue (4 items), emotional well-being (5 items), social functioning (2 items), pain (2 items), and general health (5 items). All questions are scored on a scale from 0 (worst health) to 100 (best health).
Time frame
Baseline - 1 week after stimulation - 1 month after stimulation4
Trail Making Test A and B (TMT-A and TMT-B)
The Trail Making Test (Reitan et al., 1958) consist of two parts A and B. For each part, patients need to fulfill a task by connecting letters and/or numbers in the right way. The scoring of both parts is done by taking the time required to complete them.
Time frame
Baseline - 1 week after stimulation - 1 month after stimulationSponsors and contacts
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Source ClinicalTrials.gov