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Deep Brain Stimulation for Patients With Dementia With Lewy Bodies

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02263937
Enrollment
6
Registered
2014-10-13
Start date
2014-01-31
Completion date
2016-10-31
Last updated
2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia With Lewy Bodies

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.

Interventions

PROCEDUREBilateral Nucleus Basalis Meynert DBS

Low frequency stimulation applied using standard Deep brain stimualtion hardware.

PROCEDURESham Nucleus Basalis Meynert DBS

DBS system switched off.

Sponsors

University College, London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Diagnosis of other cause for dementia * Abnormality on brain imaging considered likely to compromise compliance with trial protocol. * Prior intracerebral surgical intervention

Design outcomes

Primary

MeasureTime frame
Clinician's Assessment of Fluctuations scaleComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Hopkins Verbal Learning testComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Verbal FluencyComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Simple & Choice Reaction time taskComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Wechsler Adult Intelligence scale (WAIS IV) Digit SpanComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Posner's Covert Attention testComparing ON v OFF at 6 weeks & 14 weeks according to stimulation status

Secondary

MeasureTime frame
Trail Making testComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Stroop testComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Wechsler Adult Intelligence Scale IV - Symbol searchComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Judgement of Line OrientationComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
North East Visual Hallucinations InterviewComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Neuropsychiatric InventoryComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Florida Apraxia Screening testComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Clinical Global Impression ScaleComparing ON v OFF at 6 weeks & 14 weeks according to stimulation status
Hamilton Depression scaleComparing ON v OFF at 6 weeks & 14 weeks according to stimulation status
Starkstein Apathy Rating scaleComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Movement Disorders Society- Unified Parkinson's Disease Rating ScaleComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Freezing of Gait- questionnaireComparing 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
Quality of Life- Alzheimer's DiseaseComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Mayo Fluctuations Composite ScaleComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Blessed Dementia scaleComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Carer Strain IndexComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Short Form 36Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Hamilton Anxiety ScaleComparing 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
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
Short Recognition MemoryComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Wechsler Adult Intelligence Scale IV -Letter, Number sequencingComparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status

Other

MeasureTime frame
Adverse EventsThroughout trial period

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026