Neurocognitive Testing in Long COVID and Postural Tachycardia Syndrome Patients with Normal Saline: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 5RTI Reaction Time task (Standing)
研究概览
简要总结
Patients with Postural Orthostatic Tachycardia Syndrome (POTS) and Post-Acute Sequelae of COVID (PASC, or "Long COVID") experience cognitive dysfunction. The investigators will test the hypothesis that 999 mL of IV saline will improve cognitive function in patients with POTS and Long COVID compared to placebo (50 mL of saline).
详细描述
Many POTS patients report cognitive dysfunction, otherwise referred to as brain fog, mental fog, mental clouding, or mental fatigue. Importantly, this cognitive dysfunction can occur even while lying down or seated, limiting the ability to engage in work and educational activities. Despite the prevalence and clinical impact of cognitive dysfunction in POTS, there are limited studies examining this phenomenon. Many patients with post-acute sequelae of SARS-COV-2 (PASC, or "Long COVID") experience symptoms such as subjective cognitive impairment ("brain fog"), fatigue, memory loss, headache, and fluctuation of blood pressure, amongst other signs and symptoms. Compared to healthy controls, this study will measure cognitive function in patients with POTS and Long COVID. This study will also evaluate IV normal saline (999 mL infusion) as a potential treatment for reduced cognitive function in POTS and Long COVID. This cross-over study will use a 50 mL saline infusion as a placebo control.
The findings from this study will be an initial first step towards understanding any neurocognitive impairment in participants with long COVID and POTS patients. This is a critical first step to future studies to assess underlying pathophysiology and potential treatments.
Primary hypothesis: Some objective measures of neurocognitive functions will improve in Long COVID and POTS patients after the infusion of 999 mL of normal saline compared to 50mL placebo control.
The primary analysis will compare the standing 5RTI task on the CANTAB testing scores between 999 mL saline infusion and 50 mL saline infusion (placebo).
Study Day and Instrumentation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants and the person administering the cognitive testing will be blinded to the volume of saline infused (999 mL or 50 mL).
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with diagnosis of Long COVID
- •SARS-COV2 test positive
- •Symptoms > 12 weeks post COVID
- •Subjective complaint of 'brain fog" or cognitive dysfunction
- •Patients with diagnosis of Postural Orthostatic Syndrome (POTS) from the Calgary Autonomic Investigation and Management Clinic
- •Subjective complaint of 'brain fog" or cognitive impairment
- •Healthy participants
- •Without POTS or "brain fog"
- •Age 18 to 60 years
- •Female and Male
- •Able to give an informed consent
排除标准
- •Patients with overt causes for POTS (e.g., dehydration, prolonged bed rest)
- •An inability to safely withdraw from medicine(s) that could make test interpretation difficult and impossible.
- •Other factors which are in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule.
- •Unable to give an informed consent.
结局指标
主要结局
5RTI Reaction Time task (Standing)
时间窗: During Procedure (3 hours)
5RTI Reaction Time Score (Standing) after 999 mL IV saline compared to 5RTI score after 50 mL IV saline measured in milliseconds (ms). The minimum score is 100 ms and the maximum score is 5100 ms. A longer time is a worse outcome.
次要结局
- Verbal Recognition Memory (Verbal memory)(During Procedure (3 hours))
- Multitasking Test (Executive Function - Inhibition)(During Procedure (3 hours))
- Reaction Time Test (Psychomotor Speed)(During Procedure (3 hours))
- Paired Associates Learning (Visual Episodic Memory)(During Procedure (3 hours))