Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
102 participants
INTERVENTIONAL
2024-01-08
2027-01-31
Brief Summary
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Detailed Description
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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 G\*Power incorporated a small effect size (f = .10), α error probability of .05, and a power of 0.8, resulting in an estimate of 102 patients.
Important note: Originally, the study was designed as a multicenter study with the still-existing Austrian center (N=90) and an Italian center (N=30). Since study realization at the Italian center was ultimately not possible, the trial was streamlined to a single-center design. Consequently, enrollment at the Austrian center was refined so that at least 102 participants would reach the primary endpoint, thus meeting the original sample-size requirement. This administrative change was made prior to any analyses and does not affect the prespecified endpoints or procedures.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Verum TPS
Participants will receive 5 Verum TPS sessions over a period of 10 days, with a singular daily session, each lasting approximately 30 minutes
Transcranial pulse stimulation Verum
Participants 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.
Sham TPS
Participants will receive 5 Sham TPS sessions over a period of 10 days, with a singular daily session, each lasting approximately 30 minutes
Transcranial pulse stimulation Sham
Placebo 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.
Interventions
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Transcranial pulse stimulation Verum
Participants 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
Placebo 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.
Eligibility Criteria
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Inclusion Criteria
* 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)
* Age: 20-80
* Evidence of a negative pregnancy test if medically adequate
Exclusion Criteria
* MoCA score \<17 (cut-off for dementia)
* BDI-II score ≥29 (cut-off for severe depression)
* FIS \<10 (cut-off for no fatigue)
* Brain implants
* Non-MR-compatible metal parts in the body
* Metal parts in the head
* Use of anticoagulants
* Non-MR-compatible claustrophobia
* Non-MR-compatible pacemaker
* Pregnant and breastfeeding women
* Clinically relevant history of surgery on the head, heart, or vessels
* Relevant corticosteroid treatments administered within 6 weeks prior to the first application
* Tumor of the head if relevant for treatment
* Blood clotting disorders
* Participation in other studies
20 Years
80 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Prof. Roland Beisteiner
Professor
Principal Investigators
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Roland Beisteiner, Prof.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Medical University of Vienna
Vienna, Vienna, Austria
Countries
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Central Contacts
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Facility Contacts
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Roland Beisteiner, Prof.
Role: primary
Michael Mitterwallner, Dr.
Role: backup
References
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Douaud G, Lee S, Alfaro-Almagro F, Arthofer C, Wang C, McCarthy P, Lange F, Andersson JLR, Griffanti L, Duff E, Jbabdi S, Taschler B, Keating P, Winkler AM, Collins R, Matthews PM, Allen N, Miller KL, Nichols TE, Smith SM. SARS-CoV-2 is associated with changes in brain structure in UK Biobank. Nature. 2022 Apr;604(7907):697-707. doi: 10.1038/s41586-022-04569-5. Epub 2022 Mar 7.
Beisteiner R, Matt E, Fan C, Baldysiak H, Schonfeld M, Philippi Novak T, Amini A, Aslan T, Reinecke R, Lehrner J, Weber A, Reime U, Goldenstedt C, Marlinghaus E, Hallett M, Lohse-Busch H. Transcranial Pulse Stimulation with Ultrasound in Alzheimer's Disease-A New Navigated Focal Brain Therapy. Adv Sci (Weinh). 2019 Dec 23;7(3):1902583. doi: 10.1002/advs.201902583. eCollection 2020 Feb.
Beisteiner R, Hallett M, Lozano AM. Ultrasound Neuromodulation as a New Brain Therapy. Adv Sci (Weinh). 2023 May;10(14):e2205634. doi: 10.1002/advs.202205634. Epub 2023 Mar 24.
Cont C, Stute N, Galli A, Schulte C, Logmin K, Trenado C, Wojtecki L. Retrospective real-world pilot data on transcranial pulse stimulation in mild to severe Alzheimer's patients. Front Neurol. 2022 Sep 14;13:948204. doi: 10.3389/fneur.2022.948204. eCollection 2022.
Ashraf N, Abou Shaar B, Taha RM, Arabi TZ, Sabbah BN, Alkodaymi MS, Omrani OA, Makhzoum T, Almahfoudh NE, Al-Hammad QA, Hejazi W, Obeidat Y, Osman N, Al-Kattan KM, Berbari EF, Tleyjeh IM. A systematic review of trials currently investigating therapeutic modalities for post-acute COVID-19 syndrome and registered on WHO International Clinical Trials Platform. Clin Microbiol Infect. 2023 May;29(5):570-577. doi: 10.1016/j.cmi.2023.01.007. Epub 2023 Jan 13.
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Linnhoff S, Koehler L, Haghikia A, Zaehle T. The therapeutic potential of non-invasive brain stimulation for the treatment of Long-COVID-related cognitive fatigue. Front Immunol. 2023 Jan 9;13:935614. doi: 10.3389/fimmu.2022.935614. eCollection 2022.
Matt E, Kaindl L, Tenk S, Egger A, Kolarova T, Karahasanovic N, Amini A, Arslan A, Saricicek K, Weber A, Beisteiner R. First evidence of long-term effects of transcranial pulse stimulation (TPS) on the human brain. J Transl Med. 2022 Jan 15;20(1):26. doi: 10.1186/s12967-021-03222-5.
Matt E, Dorl G, Beisteiner R. Transcranial pulse stimulation (TPS) improves depression in AD patients on state-of-the-art treatment. Alzheimers Dement (N Y). 2022 Feb 10;8(1):e12245. doi: 10.1002/trc2.12245. eCollection 2022.
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Popescu T, Pernet C, Beisteiner R. Transcranial ultrasound pulse stimulation reduces cortical atrophy in Alzheimer's patients: A follow-up study. Alzheimers Dement (N Y). 2021 Feb 25;7(1):e12121. doi: 10.1002/trc2.12121. eCollection 2021.
Radjenovic S, Dorl G, Gaal M, Beisteiner R. Safety of Clinical Ultrasound Neuromodulation. Brain Sci. 2022 Sep 22;12(10):1277. doi: 10.3390/brainsci12101277.
Santana K, Franca E, Sato J, Silva A, Queiroz M, de Farias J, Rodrigues D, Souza I, Ribeiro V, Caparelli-Daquer E, Teixeira AL, Charvet L, Datta A, Bikson M, Andrade S. Non-invasive brain stimulation for fatigue in post-acute sequelae of SARS-CoV-2 (PASC). Brain Stimul. 2023 Jan-Feb;16(1):100-107. doi: 10.1016/j.brs.2023.01.1672. Epub 2023 Jan 21.
Soriano JB, Murthy S, Marshall JC, Relan P, Diaz JV; WHO Clinical Case Definition Working Group on Post-COVID-19 Condition. A clinical case definition of post-COVID-19 condition by a Delphi consensus. Lancet Infect Dis. 2022 Apr;22(4):e102-e107. doi: 10.1016/S1473-3099(21)00703-9. Epub 2021 Dec 21.
Tran VT, Porcher R, Pane I, Ravaud P. Course of post COVID-19 disease symptoms over time in the ComPaRe long COVID prospective e-cohort. Nat Commun. 2022 Apr 5;13(1):1812. doi: 10.1038/s41467-022-29513-z.
Weinreb E, Moses E. Mechanistic insights into ultrasonic neurostimulation of disconnected neurons using single short pulses. Brain Stimul. 2022 May-Jun;15(3):769-779. doi: 10.1016/j.brs.2022.05.004. Epub 2022 May 11.
Zeng N, Zhao YM, Yan W, Li C, Lu QD, Liu L, Ni SY, Mei H, Yuan K, Shi L, Li P, Fan TT, Yuan JL, Vitiello MV, Kosten T, Kondratiuk AL, Sun HQ, Tang XD, Liu MY, Lalvani A, Shi J, Bao YP, Lu L. A systematic review and meta-analysis of long term physical and mental sequelae of COVID-19 pandemic: call for research priority and action. Mol Psychiatry. 2023 Jan;28(1):423-433. doi: 10.1038/s41380-022-01614-7. Epub 2022 Jun 6.
Other Identifiers
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102307161
Identifier Type: -
Identifier Source: org_study_id
102307161
Identifier Type: OTHER
Identifier Source: secondary_id