A Pilot Randomized Trial of rTMS for Fatigue and Brain Fog and Neuropsychiatric Symptoms of Long-COVID.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Tolerability as measured by Safteesi survey
研究概览
简要总结
This is a pilot randomized trial of rTMS for symptoms of fatigue and brain fog, and other neuropsychiatric symptoms of Long-COVID (Post-COVID, post-acute sequelae of COVID-19 infection, PASC). Twenty participants diagnosed with Long-COVID and recruited from the UCLA Long-COVID clinic will be randomized to receive active rTMS versus sham stimulation for 15 treatments followed by another 15 open-label rTMS treatments. Investigators will compare the safety and tolerability of rTMS vs Sham and examine within-group changes in symptoms of fatigue, sleep, pain, mood, and subjective and objective cognitive impairment. This project will provide information and pilot data for future larger clinical trials.
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 and investigators and outcomes assessors will be blind to the assignment to active or sham rTMS
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18+ years of age
- •Prior hx of PCR confirmed COVID-19 infection. Determined by the PI or participant's physician.
- •Subsequent development of post-acute neuropsychiatric symptoms with fatigue and brain fog as primary outcomes
- •USE of Psychotropic medications
- •Stable on psychotropic medications for 4+ months
- •Confirmed diagnosis of Long COVID
- •Subjects are willing and able to adhere to the treatment schedule and required study visits
排除标准
- •Mentally or legally incapacitated or unable to give informed consent
- •MOCA < or = 24
- •Infection of poor skin condition over the scalp where the rTMS device will be positioned
- •Pregnancy: Female participants will be tested for pregnancy at baseline and agree to use a medically acceptable form of birth control throughout the study, for women younger than
- •Lifetime history of diagnosed bipolar disorder; psychosis, such as schizophrenia, schizophreniform, or schizoaffective disorder; intellectual disability (intellectual developmental disorder); organic brain damage; or suicide attempts in the past 24 months.
- •Severe MDD with suicidality of Psychosis- excluded
- •As-needed use of benzodiazepines and beta-blockers will be permitted but discouraged during assessment days.
- •Current abuse or dependence on alcohol or any illicit drug of abuse (disorder in last 6 months). Any recent use of cocaine or opiates will also be exclusionary.
- •Participants with asthma or with a history of serious, uncontrolled medical illness or instability (including significant cardio-pulmonary disease, organic brain including significant cardio-pulmonary syndrome, pre-existing dementia, seizure disorder, cerebrovascular disease, and diabetes)
- •Taking medications known to lower seizure thresholds (Clozaril/ Wellbutrin)
- •Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or primary or secondary tumors in the central nervous system.
- •Presence of an implanted metallic and magnetic-sensitive medical device present in the body scan, including but not limited to a cochlear implant, infusion pump, implanted cardioverter defibrillator, pacemaker, vagus nerve stimulator, aneurysm clip, metal prosthesis, or metal aneurysm clips or coils, staples, or stents.
研究组 & 干预措施
active rTMS
The rTMS magnet will be set to active stimulation without the knowledge of treating doctors or research team. Only one technician will know the randomization list assignment and will adjust the settings. rTMS treatment will include rTMS to the left dorsolateral prefrontal cortex (DLPFC), followed by rTMS to left primary motor cortex (M1).
干预措施: rTMS (Device)
Sham rTMS
The rTMS magnet will be set to sham stimulation without the knowledge of the treating doctors or the research team.
干预措施: rTMS (Device)
结局指标
主要结局
Tolerability as measured by Safteesi survey
时间窗: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
Safteesi is an instrument that assesses any new symptom(s) that participants developed since starting the clinical study.
Safety profile and adverse events
时间窗: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
Study patients will be monitored weekly for the occurrence of adverse events.
次要结局
- Subjective Cognitive impairment assessed by Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)(Baseline, after every 5th treatment, through study completion, an average of 12 weeks.)
- Fatigue assessed by Fatigue Severity Scale (FSS)(Baseline, after every 5th treatment, through study completion, an average of 12 weeks.)
- Physical and mental health assessed by PROMIS-29(Baseline, through study completion, an average of 12 weeks.)
- Alzheimer's Disease Assessment Scale (ADAS-Cog)(Baseline through study completion, an average of 12 weeks.)
- Fatigue assessed by VAS for Fatigue Questionnaire(Baseline, after every 5th treatment, through study completion, an average of 12 weeks.)
- DKEFS CW(Baseline through study completion, an average of 12 weeks.)
- Verbal Fluency test(Baseline through study completion, an average of 12 weeks.)
- DKEFS Trailmaking A,B(Baseline through study completion, an average of 12 weeks.)
- Test of Premorbid Functioning (TOPF)(Baseline)
- Repeatable Battery for the Assessment of Neuropsychological (RBANS)(Baseline through study completion, an average of 12 weeks.)
- DKEFS CWI(Baseline through study completion, an average of 12 weeks.)
- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(Baseline through study completion, an average of 12 weeks.)
研究者
Helen Lavretsky, MD
professor
University of California, Los Angeles