Deep Brain Stimulation for Patients With Dementia With Lewy Bodies
- Conditions
- Dementia With Lewy Bodies
- Interventions
- Procedure: Bilateral Nucleus Basalis Meynert DBSProcedure: Sham Nucleus Basalis Meynert DBS
- Registration Number
- NCT02263937
- Lead Sponsor
- University College, London
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- 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
- Diagnosis of other cause for dementia
- Abnormality on brain imaging considered likely to compromise compliance with trial protocol.
- Prior intracerebral surgical intervention
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Bilateral Nucleus Basalis Meynert DBS Bilateral Nucleus Basalis Meynert DBS 6 week period of active NBM DBS Sham Nucleus Basalis Meynert DBS Sham Nucleus Basalis Meynert DBS 6 week period of Sham DBS
- Primary Outcome Measures
Name Time Method Hopkins Verbal Learning test Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status Verbal Fluency Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status Simple & Choice Reaction time task Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status Posner's Covert Attention test Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status Wechsler Adult Intelligence scale (WAIS IV) Digit Span Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status Clinician's Assessment of Fluctuations scale Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
UCL Institute of Neurology
🇬🇧London, United Kingdom
University of Newcastle
🇬🇧Newcastle, United Kingdom