Transcranial Pulse Stimulation (TPS) in Post-COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Fatigue Impact Scale (FIS)
研究概览
简要总结
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.
详细描述
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 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 102 patients. The randomization ratio is 1:1, 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, 6 months post-stimulation, 12 months post-stimulation, and 24 months post-stimulation.
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All participants as well as the principal investigator, evaluating investigators, and the teams responsible for conducting stimulations, neuropsychological testing, and MR testing will be blinded. Specific individuals responsible for the organization of the study, who are neither involved in stimulation nor data collection, will not be blinded and will apply the verum or sham standoff device to the NEUROLITH system for a specific patient. As the stimulation team members won't have knowledge of the standoff device in use, they will remain completely blinded.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •Age: 20-80
- •Evidence of a negative pregnancy test if medically adequate
排除标准
- •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)
- •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
结局指标
主要结局
Fatigue Impact Scale (FIS)
时间窗: Baseline - 1 week after stimulation - 1 month after stimulation
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.
次要结局
- Positive and Negative Affect Schedule (PANAS)(Baseline - 1 week after stimulation - 1 month after stimulation)
- Trail Making Test A and B (TMT-A and TMT-B)(Baseline - 1 week after stimulation - 1 month after stimulation)
- Six Minute Walking Test (6MWT)(Baseline - 1 week after stimulation - 1 month after stimulation)
- Montreal Cognitive Assessment (MOCA)(Baseline - 1 week after stimulation - 1 month after stimulation)
- 36-Item Short Form Health Survey (SF-36)(Baseline - 1 week after stimulation - 1 month after stimulation)
- Test of Attentional Performance (TAP)(Baseline - 1 week after stimulation - 1 month after stimulation)
- Satisfaction With Life Scale (SWLS)(Baseline - 1 week after stimulation - 1 month after stimulation)
- Beck Depression Inventory (BDI-II)(Baseline - 1 week after stimulation - 1 month after stimulation)
- Beck Anxiety Inventory (BAI)(Baseline - 1 week after stimulation - 1 month after stimulation)
- Verbal Learning and Memory Test (VLMT)(Baseline - 1 week after stimulation - 1 month after stimulation)
- Stroop color word test (STROOP)(Baseline - 1 week after stimulation - 1 month after stimulation)
- Neuroimaging(Baseline - 1 week after stimulation - 1 month after stimulation)
- Somatization subscale of the Symptom Check List-90-R (SCL-90-R SOM)(Baseline - 1 week after stimulation - 1 month after stimulation)
- Post-Exertional Malaise (BI-PEM)(Baseline - 1 week after stimulation - 1 month after stimulation)
研究者
Prof. Roland Beisteiner
Professor
Medical University of Vienna