Investigating the Neurophysiology of the Motor System and the Feasibility of Vagus Nerve Stimulation in Functional Neurological Disorder (FND): a Randomized, Sham-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Self-reported quality of life
研究概览
简要总结
This clinical study will test if adding a non-invasive stimulation of the vagus nerve through the ear during physiotherapy brings an improvement to FND (Functional Neurological Disorder) patients with motor symptoms.
First, the investigators will test the normal functioning of the motor regions of the brain in FND patients and in healthy volunteers for comparison, using a painless method called TMS (Transcranial Magnetic Stimulation). Then, the investigators will further test how brain regions communicate with each other in FND patients, using fMRI (functional Magnetic Resonance Imaging, also painless). Additionally, the investigators will ask both FND patients and healthy volunteers to answer questions about their health and wellbeing, and will assess the exact symptoms of FND patients. The FND patients will then be assigned to two groups randomly, and neither they nor the researchers will know in which group they are. Both groups will do 5 sessions of their usual physiotherapy - one group with a real stimulation of the vagus nerve, and the other group with a fake stimulation. This is important to obtain reliable results. At the end, both groups of patients will be tested again to see if the way brain regions communicate with each other has changed. They will also answer again questions about their health and wellbeing, and their symptoms will be assessed again, to see if any changes happen. The results of the two groups of patients will be compared to isolate the effects of vagus nerve stimulation from the effects of physiotherapy alone.
详细描述
The main goal of this project is to better understand the neurophysiology of the motor system and the role of attention in Functional Neurological Disorder (FND) and to explore the physiological effects of a novel non-invasive treatment option for this disorder.
To this end, several methods will be employed: non-invasive brain stimulation (using Transcranial Magnetic Stimulation, TMS), neuroimaging (fMRI), transdermal auricular vagus nerve stimulation (taVNS), clinical assessments and questionnaires.
The study consists of 2 experiments, each with specific objectives.
Primary objective:
The primary objective of this study is to assess the effects of taVNS, as an adjunctive intervention to standard physical therapy, on the quality of life in FND patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
In addition, half of the investigator will be blind of the intervention groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for FND patients:
- •Over 18 years of age.
- •Capable of judgement.
- •Willing to participate in the study (by signing the informed consent form).
- •FND diagnosis by a certified neurologist or psychiatrist.
- •Motor FND symptoms in the upper limb in the form of tremor or weakness.
- •Participating in physiotherapy for FND.
排除标准
- •for FND patients:
- •Severe neuropsychiatric comorbidities.
- •Pregnancy or breastfeeding.
- •Prior knowledge on the effects of attention on the motor system.
- •Prior history of epilepsy or epileptic seizures in the person and their family.
- •Severe claustrophobia.
- •Implanted medical devices.
- •Ear anatomy incompatible with the taVNS device (e.g. cauliflower ear).
- •Previous use of taVNS.
- •Substance abuse.
- •Simultaneous participation in another investigation involving an investigational drug or a MD.
- •Enrolment of the PI and their dependent persons.
- •Inclusion Criteria for healthy volunteers:
- •Over 18 years of age.
- •Capable of judgement.
- •Willing to participate in the study (by signing the informed consent form).
- •Exclusion Criteria for healthy volunteers:
- •Neurological or neuropsychiatric or movement disorders.
- •Pregnancy or breastfeeding.
- •Prior knowledge on the effects of attention on the motor system.
- •Prior history of epilepsy or epileptic seizures in the person and their family.
- •Substance abuse.
- •Simultaneous participation in another investigation involving an investigational drug or a MD.
- •Enrolment of the PI and their dependent persons.
结局指标
主要结局
Self-reported quality of life
时间窗: For each intervention session at weeks 3, 4, 5, 6, 7
The change in self-reported quality of life, measured through intervention sessions with the Euro Quality of Life questionnaire (EQ-5D-5L), compared between the active stimulation group and the sham stimulation group. This questionnaire includes 5 subscales (1-best, 5-worstest) about mobility, self-care, usual activities, pain/discomfort, anxiety/depression. In addition it includes a continue scale evaluation (0-worst to 100-best) about the patient evaluation on his health.
次要结局
- Neurophysiology investigation of the pathology by comparing Motor-Evoked Potential between FND patients and healthy participant(At TMS session, week 2 for patients and week 0 for heathy controls)
- Neurophysiology investigation of the pathology by comparing resting motor threshold between FND patients and healthy participant(At TMS session, week 2 for patients and week 0 for heathy controls)
- General heath condition questionnaire(week 0)
- Comparison of motor performance between patients and healthy controls(At TMS session, week 2 for patients and week 0 for heathy controls)
- Satisfaction rating of patients on the intervention(At the end of the last intervention session at week 7)
- Changes in upper limb strength, measured by a grip strength test under different starting conditions, before, during and after taVNS intervention.(weeks 2, 3, 4, 5, 6, 7)
- Changes in parasympathetic tone measured by heart rate variability(During intervention sessions at weeks 3, 4, 5, 6, 7)
- Change in functional connectivity, measured by resting-state fMRI(weeks 0, 8)
- Study the evolution of symptom severity score(weeks 1, 2, 3, 4, 5, 6, 7, 8)
- Study evolution of perceived stress(weeks 1, 2, 3, 4, 5, 6, 7, 8)
- Study the evolution of the clinical global impression score(weeks 1, 2, 3, 4, 5, 6, 7, 8)
- Study the evolution of depression evaluation(weeks 2, 8)
- Study the evolution of stress evaluation(weeks 2, 8)
- Study the evolution of interoception evaluation(weeks 0, 8)
- Study the evolution of functional movement disorders rating scale(weeks 0, 8)
- Satisfaction rating of physiotherapists on the intervention(At the end of the last intervention session at week 7)