Multimodal Investigation of Post COVID-19 in Females: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Picture Sequence Memory Test (PSMT) scores
研究概览
简要总结
The purpose of this study is to investigate the effects of transcutaneous vagus nerve stimulation (t-VNS) on Long Covid symptoms in females and to identify factors influencing susceptibility and recovery-particularly in the cognitive domain, as over 80% of long-haulers experience "brain fog".
详细描述
Long COVID is a post-viral illness estimated to affect 10-30% of COVID-19 patients. Post-COVID symptoms can last for months and affect multiple organs. Major risk factors of long COVID include the female sex and pre-existing anxiety/depression. Because women already have higher rates of anxiety/depression, the combined risks could exacerbate their susceptibility.
Based on the rationale that long COVID symptoms significantly overlap with functions of the vagus nerve, which serves as a conduit between the brain and body, the investigators propose to use non-invasive transcutaneous vagus nerve stimulation (t-VNS) as a novel treatment for long COVID in 20 female participants.
This pilot study will utilize a holistic approach by integrating neuromodulation, neuroimaging, genetics, blood biomarkers, behavioral assessments, and wearable technology to examine the effects of VNS therapy on post COVID-19 symptoms and to identify factors that influence susceptibility and recovery, particularly in the cognitive domain, as over 80% of long-haulers report experiencing "brain fog" (i.e., cognitive disruptions).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biologically female at birth and at time of enrollment
- •At least 18 years of age or older
- •Experiencing persistent symptoms of brain fog/cognitive impairment beyond 3 months of COVID-19 infection that are not explained by an alternative diagnosis
排除标准
- •Not t-VNS compatible (e.g. pacemaker implants)
- •Not MRI compatible (e.g. metal implants, claustrophobia)
- •Currently pregnant
- •Long COVID without cognitive impairment
- •History of neurological conditions prior to COVID-19 infection
结局指标
主要结局
Change in Picture Sequence Memory Test (PSMT) scores
时间窗: At baseline, at week 3, and at week 7
PSMT is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's episodic memory.
Change in Dimensional Change Card Sort Test (DCCS) scores
时间窗: At baseline, at week 3, and at week 7
DCCS is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's executive functioning.
Change in Flanker Inhibitory Control and Attention Test (Flanker) scores
时间窗: At baseline, at week 3, and at week 7
Flanker is a non-verbal NIH Toolbox Cognition Battery assessment that measures both a participant's attention and inhibitory control.
Change in Pattern Comparison Processing Speed scores
时间窗: At baseline, at week 3, and at week 7
Pattern Comparison Processing Speed is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's processing speed.
Change in List Sorting Working Memory scores
时间窗: At baseline, at week 3, and at week 7
List Sorting Working Memory is an oral NIH Toolbox Cognition Battery assessment that measures a participant's working memory.
次要结局
- Change in Magnetic Resonance Imaging (MRI)(At baseline and at week 3)
- Change in PROMIS Sleep Disturbance scores(At baseline, at week 3, and at week 7)
- Change in Sniffin' Sticks olfactory performance(At baseline, at week 3, and at week 7)
- Change in resting state Electroencephalograph (EEG) signals(At baseline and at week 3)
- Change in blood marker levels(At baseline and at week 3)
- Change in Becks Depression Inventory (BDI) scores(At baseline, at week 3, and at week 7)
- Change in BURNS Anxiety Inventory scores(At baseline, at week 3, and at week 7)
- Change in Fatigue Severity Scale scores(At baseline, at week 3, and at week 7)
研究者
Amy Zheng
Research Scientist
Casa Colina Hospital and Centers for Healthcare