Deep Brain Stimulation for Autonomic and Gait Symptoms in Multiple System Atrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Fluency of gait as measured by accelerometry before and after deep brain stimulation
研究概览
简要总结
Patients referred to neurosurgery routinely and safely undergo deep brain stimulation (DBS) for treatment of symptoms related to neurodegenerative conditions, most commonly Parkinson's disease.
In the investigators experience, and published evidence shows, that stimulation has effects on the autonomic nervous system. In patients undergoing therapeutic DBS for a particular subtype of Parkinsonism, Multiple System Atrophy, the further effects on autonomic parameters such as blood pressure and bladder symptoms as well as the originally intended indications (gait and movement disorder) will be investigated. The mechanisms of any effects will also be studied by using a number of techniques such as magnetoencephalography (MEG) and Muscle Sympathetic Nerve Activity (MSNA) recording.
Key goals are to:
- Demonstrate that stimulation of the peduculopontine nucleus (PPN) improves autonomic function and has an attendant improvement on patients' quality of life
- Investigate the role of the PPN and how it interacts with other brain areas.
This translational strategy will lead to a larger efficacy study of DBS for MSA as well as revolutionizing neural-based treatments in other autonomic disorders such as orthostatic hypotension and pure autonomic failure.
详细描述
AIMS OF THE PROJECT AND IMPORTANCE
Multiple system atrophy (MSA) is a form of Parkinsonism and is a neurodegenerative condition that is characterized by gait and autonomic failure. MSA symptoms are generally poorly responsive to medicines that treat Parkinson's disease (PD), and so symptom control is difficult.
The aim is to assess the effects of deep brain stimulation (DBS) of the pedunculopontine nucleus (PPN) on autonomic and gait symptoms to show that it improves quality of life in patients with MSA.
Secondary aims are to assess the effects of stimulation on autonomic parameters (cardiovascular and bladder function) as well as the routine parameters of the movement disorder (gait, freezing and falls, etc).
In addition, there is a mechanistic component of the study looking at both peripheral autonomic activity and brain networks associated with stimulation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MSA with disabling autonomic symptoms (bladder dysfunction and orthostatic symptoms
- •UMSARS score of >40
- •>6/12 in the autonomic subsection (Q9-12) of the UMSAR scale
- •Patient willing and able to give informed consent to involvement in the study.
- •Male or female, aged 18 years or over.
- •Able to walk unaided (to perform gait analysis)
- •Have an anticipated prognosis > 2 years
排除标准
- •The patient is unwilling to participate or unable to give informed consent.
- •The patient has been deemed unfit for stimulator insertion by their healthcare team i.e. surgical contraindications to DBS:
- •Bleeding or coagulation disorder
- •Not fit for general anaesthetic
- •Unable to deal with implanted DBS system (turn on and off and recharging where applicable, although it is acceptable if a carer can do this)
- •Untreated anxiety or depression
- •Unable to undergo MRI (eg. metal implants)
- •Subject is currently participating in a clinical investigation that includes an active treatment arm.
- •Female who is pregnant - testing will be offered to female patients who are unsure.
结局指标
主要结局
Fluency of gait as measured by accelerometry before and after deep brain stimulation
时间窗: Through study completion, but on average, over an 8 month period for each patient
Measurement of gait parameters before and after surgery
EuroQol 5 Dimension (5 level) score before and after deep brain stimulation
时间窗: Through study completion, but on average, over an 8 month period for each patient
Measurement of quality of life before and after surgery. Results will be given as description of health states - it is not quantitative.
Modified composite autonomic symptom scale before and after deep brains stimulation
时间窗: Through study completion, but on average, over an 8 month period for each patient
Measurement of autonomic symptomatology before and after surgery - Score from 0-100
Change in postural blood pressure change before and after PPN DBS
时间窗: Through study completion, but on average, over an 8 month period for each patient
Measurement of effect on postural blood pressure change before and after surgery
次要结局
- Cortical magentoencephalography profile with deep brain stimulation on and off(3-6 months after surgery)
- Number of Participants With Treatment-Related Adverse Events as Assessed by using approved UK reporting procedure(Through study completion, 2 years)
- Muscle sympathetic nerve activity before and after deep brain stimulation(Through study completion, but on average, over an 8 month period for each patient)
- Physical anatomical white matter connections between the pedunculopontine nucleus and the rest of the central nervous system(Before surgery and 3-6 months after surgery)