Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510985
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Transcutaneous Vagus Nerve Stimulation tVNS for Improved Recovery After Exertion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transcutaneous Vagus Nerve Stimulation tVNS for Improved Recovery After Exertion in Patients With LongPost-COVID
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Widespread infection with SARS-CoV-2 has resulted in millions of people having Post-COVID Post-COVID is a complex non-monolithic disease with diverse clinical manifestations Symptoms range from fatigue brain fog muscle aches and shortness of breath affecting multiple organ systems simultaneously To directly address this multi-organ component of Post-COVID innovative treatment methods are urgently needed One potential treatment that we will investigate in our study is the intervention via the vagus nerve as the cranial nerve plays a central role in communication between the body and the brain and influences targeted behavior This innovative approach is based on our clinically relevant findings regarding the effects where acute tVNS increased the level of effort Neuser et al 2020 Ferstl et al 2021 specifically targeting a key symptom of Post-COVID In the proposed study the investigators aim to investigate the effectiveness of transcutaneous vagus nerve stimulation tVNS as a non-invasive self-administered treatment for Post-COVID symptoms at home To evaluate the clinically relevant effects of repeated taVNS application high-intensity stimulation the investigators will employ a randomized cross-over design to investigate stimulation-induced changes in fatigue depression and motivation to work for reward compared to low-intensity stimulation and to a control group
Detailed Description:
The proposed study aims to advance the understanding of Post-COVID treatment using a randomized cross-over design to evaluate the taVNS-induced changes over 12 weeks A hundred twenty patients diagnosed with LongPost-COVID are randomly assigned to one of three groups related to the two arms of the study Monitoring with lowhigh-intensity stimulation vs Monitoring without stimulation In the treatment group forty patients will start with high-intensity taVNS for 6 weeks then switch to low-intensity stimulation for an additional 6 weeks Another 40 patients begin with low-intensity stimulation for 6 weeks followed by high-intensity taVNS stimulation The control group Monitoring without stimulation is able to receive taVNS after participation in the study
The treatment group and the control group will participate in the same monitoring procedures All participants will attend an initial laboratory session to complete several baseline assessments including questionnaires measuring energy expenditure via indirect calorimetry and completing a body silhouette task Blood samples are taken at every session to evaluate changes in metabolic and inflammatory markers To assess the motivation to work for rewards the investigators employ an effort-based-cost-benefit paradigm Effort Allocation Task All these lab assessments will be repeated after 6 and 12 weeks to evaluate stimulation-induces changes in primary and secondary outcomes In addition all participants are given a cardio bracelet to monitor physiological parameters eg heart rate heart rate variability breathing skin conductance step counts over the study period Over the 12 weeks the treatment group will self-administer taVNS for four hours daily in a targeted manner anticipating forthcoming exertion and stimulating in anticipation of an effortful event to enhance the patients motivational drive and recovery Another essential part of the study is the monitoring over the 12 weeks All participants will complete daily ecological momentary assessments via smartphone to monitor their mental states In addition participants will perform once a day one of two discounting games effort or temporal discounting task to investigate changes in their decision behavior over time The effort discounting task is essential to assess the motivation of post-COVID patients to pursue subjectively effortful situations over the 12 weeks
The treatment group and the control group will participate in the same monitoring procedures All participants will attend an initial laboratory session to complete several baseline assessments including questionnaires measuring energy expenditure via indirect calorimetry and completing a body silhouette task Blood samples are taken at every session to evaluate changes in metabolic and inflammatory markers To assess the motivation to work for rewards the investigators employ an effort-based-cost-benefit paradigm Effort Allocation Task All these lab assessments will be repeated after 6 and 12 weeks to evaluate stimulation-induces changes in primary and secondary outcomes In addition all participants are given a cardio bracelet to monitor physiological parameters eg heart rate heart rate variability breathing skin conductance step counts over the study period Over the 12 weeks the treatment group will self-administer taVNS for four hours daily in a targeted manner anticipating forthcoming exertion and stimulating in anticipation of an effortful event to enhance the patients motivational drive and recovery Another essential part of the study is the monitoring over the 12 weeks All participants will complete daily ecological momentary assessments via smartphone to monitor their mental states In addition participants will perform once a day one of two discounting games effort or temporal discounting task to investigate changes in their decision behavior over time The effort discounting task is essential to assess the motivation of post-COVID patients to pursue subjectively effortful situations over the 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None