Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178952
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2023-12-20
Brief Title:
Transcranial Pulse Stimulation TPS in Post-COVID-19
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Transcranial Pulse Stimulation TPS in Post-COVID-19
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
This clinical trial aims to investigate the treatment efficacy of transcranial pulse stimulation TPS using the NEUROLITH device Storz Medical AG Tägerwilen Switzerland in individuals with neurological post-COVID-19-symptoms TPS is a novel brain stimulation therapy based on non-invasive ultrasound pulses and first published in 2019 by the Medical University of Vienna Austria Beisteiner et al Advanced Science 2019 The study employs a double-blind randomized placebo-controlled multicenter- design with parallel groups verum vs sham The anticipated timeframe for the entire study is 2 years during which each participant is expected to be actively engaged for a period of 3-4 months The aim is to include 120 patients with 90 individuals participating in the Austrian center and 30 in the Italian center The randomization ratio is 11 ensuring an even distribution between the verum active treatment and sham placebo groups Three assessment points are scheduled Baseline PostStim 1monthPostStim Furthermore to determine potential effects over time limited data collection involving only FIS BDI-II SF-36 and BI-PEM is planned at later time points specifically at 3 months post-stimulation and 6 months post-stimulation only at the Austrian center
Hypotheses
H0 There is no significant difference in the effectiveness of transcranial pulse stimulation TPS and placebo treatment in improving primary and secondary endpoints
H1 There is a significant difference in the effectiveness of transcranial pulse stimulation TPS and placebo treatment in improving primary and secondary endpoints
Timeline
Each study participant will undergo the following sequence
1 Initial information session and clarification of relevant medical findings regarding inclusion and exclusion criteria
2 Baseline screening
3-4 assessment sessions per patient within 14 days including informed consent
Patients who do not meet the predefined cut-off values for BDI FIS and MoCA will be excluded from subsequent study phases
3 Transcranial pulse stimulation
5 stimulations per patient within 10 days
One stimulation per day lasting approximately 30 minutes
4 Post-stimulation assessment PostStim
Conducted during the week following brain stimulation
2-3 assessment sessions per patient within 7 days
5 One-month post-stimulation assessment 1monthPostStim
Conducted one month after brain stimulation
2-3 assessment sessions per patient within 7 days
Deviations of 5 days from the intended timeline are considered tolerable
Sample Size Calculation
The sample size calculation conducted with GPower incorporated a small effect size f 10 α error probability of 05 and a power of 08 resulting in an estimate of 102 patients While the consideration of a 125 drop-out rate from a previous study Beisteiner et al 2019 would yield a sample size of 11475 a more conservative approach is being employed To ensure sufficient participant numbers the aim is to enroll 120 patients
Italian Center Adaptation The Italian center will use the Austrian center as a template while considering available resources potentially leading to a reduced number of data collection instruments and sessions per assessment point After obtaining approval this passage will be revised to include relevant information for the Italian center
indicates aspects of the planned multicenter design The center in Italy is currently undergoing the approval process Updates to this page will be made once confirmations are obtained
Hypotheses
H0 There is no significant difference in the effectiveness of transcranial pulse stimulation TPS and placebo treatment in improving primary and secondary endpoints
H1 There is a significant difference in the effectiveness of transcranial pulse stimulation TPS and placebo treatment in improving primary and secondary endpoints
Timeline
Each study participant will undergo the following sequence
1 Initial information session and clarification of relevant medical findings regarding inclusion and exclusion criteria
2 Baseline screening
3-4 assessment sessions per patient within 14 days including informed consent
Patients who do not meet the predefined cut-off values for BDI FIS and MoCA will be excluded from subsequent study phases
3 Transcranial pulse stimulation
5 stimulations per patient within 10 days
One stimulation per day lasting approximately 30 minutes
4 Post-stimulation assessment PostStim
Conducted during the week following brain stimulation
2-3 assessment sessions per patient within 7 days
5 One-month post-stimulation assessment 1monthPostStim
Conducted one month after brain stimulation
2-3 assessment sessions per patient within 7 days
Deviations of 5 days from the intended timeline are considered tolerable
Sample Size Calculation
The sample size calculation conducted with GPower incorporated a small effect size f 10 α error probability of 05 and a power of 08 resulting in an estimate of 102 patients While the consideration of a 125 drop-out rate from a previous study Beisteiner et al 2019 would yield a sample size of 11475 a more conservative approach is being employed To ensure sufficient participant numbers the aim is to enroll 120 patients
Italian Center Adaptation The Italian center will use the Austrian center as a template while considering available resources potentially leading to a reduced number of data collection instruments and sessions per assessment point After obtaining approval this passage will be revised to include relevant information for the Italian center
indicates aspects of the planned multicenter design The center in Italy is currently undergoing the approval process Updates to this page will be made once confirmations are obtained
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 102307161 | OTHER | BASG Austrian Agency for Health and Food Safety | None |