Double Blind, Randomised, Dual Centre, Crossover, Pilot Trial of Bilateral Nucleus Basalis of Meynert Deep Brain Stimulation to Improve Cognitive Deficits in Patients With Dementia With Lewy Bodies.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Verbal Fluency
研究概览
简要总结
This trial aims to collect pilot data to explore whether bilateral deep brain stimulation (DBS) of the Nucleus Basalis of Meynert (NBM) has beneficial effects on memory and thinking impairments among individuals with Dementia with Lewy Bodies (DLB).
详细描述
We will perform a pilot study to evaluate the effectiveness of human NBM DBS at improving cognitive deficits in DLB patients. Six patients with DLB with moderate cognitive impairments (including but not restricted to deficits in attention and working memory) will have bilateral DBS electrodes implanted to ensure that superficial contacts lie in the motor Globus Pallidum interna (GPi) target, while the deepest electrical contacts lie in the NBM. We will place electrodes using our conventional image-guided, stereotactic frame-based procedure. Once the surgical wounds have healed, patients will be randomised into 2 groups in a crossover trial design to have 6 week periods of NBM stimulation switched on or switched off separated by a 2 week washout period, following which the patient will cross over to have the opposite condition for a further 6 weeks. Outcome measures collected at the 6 weeks and 14 weeks timepoints will be compared according to whether each patient was ON or OFF stimulation at that timepoint.
At the end of the crossover period, all patients will be invited for continued follow up with stimulation switched on and will have neuropsychological evaluations at 6 monthly intervals. Patients will be given the option of receiving additional conventional stimulation to the motor GPi, through the higher contacts of each electrode, at the end of the crossover period if required for any coexisting Parkinsonian motor complications of DLB.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DLB Consortium Criteria for diagnosis
- •Score between 2 & 12 on Clinician Assessment of Fluctuations scale
- •MMSE score between 21 and 27
- •Appropriate Surgical candidates in terms of general health
- •Aged between 50 & 80
- •Able to give Informed consent
- •Living at home with Carer
- •Able to comply with protocol
- •On stable dosage of cholinesterase inhibitor
排除标准
- •Diagnosis of other cause for dementia
- •Abnormality on brain imaging considered likely to compromise compliance with trial protocol.
- •Prior intracerebral surgical intervention
结局指标
主要结局
Verbal Fluency
时间窗: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Simple & Choice Reaction time task
时间窗: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Posner's Covert Attention test
时间窗: Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status
Wechsler Adult Intelligence scale (WAIS IV) Digit Span
时间窗: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Hopkins Verbal Learning test
时间窗: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Clinician's Assessment of Fluctuations scale
时间窗: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
次要结局
- Wechsler Adult Intelligence Scale IV -Letter, Number sequencing(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Trail Making test(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Dementia Rating Scale (DRS-2)(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Wechsler Abbreviated Scale of Intelligence (WASI)(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Minimental State Examination (MMSE)(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Judgement of Line Orientation(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Stroop test(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Neuropsychiatric Inventory(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Short Recognition Memory(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Wechsler Adult Intelligence Scale IV - Symbol search(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- North East Visual Hallucinations Interview(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Clinical Global Impression Scale(Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status)
- Hamilton Depression scale(Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status)
- Starkstein Apathy Rating scale(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Movement Disorders Society- Unified Parkinson's Disease Rating Scale(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Quality of Life- Alzheimer's Disease(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Florida Apraxia Screening test(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Blessed Dementia scale(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Carer Strain Index(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Hamilton Anxiety Scale(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Short Form 36(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Freezing of Gait- questionnaire(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Scales for outcome in Parkinson's disease (SCOPA - AUT)(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)
- Mayo Fluctuations Composite Scale(Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status)