Deep Brain Stimulation for patients with Dementia with Lewy Bodies
Research type
Research Study
Full title
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.
IRAS ID
138104
Contact name
Thomas Foltynie
Contact email
Sponsor organisation
UCL
Research summary
We will perform a pilot study to evaluate the effectiveness of deep brain stimulation (DBS) at improving cognitive deficits in patients with DLB (Dementia with Lewy Bodies). This is a dementing illness which currently has no effective therapies available - the patients suffer gradually worsening problems with memory, attention and hallucinations over time. The underlying disease process involves the degeneration of the NBM (nucleus basalis of Meynert), a deep area of the brain known to play a crucial role in memory formation and other cognitive functions such as attention. By electrically stimulating the surviving parts of the NBM we hope to boost its activity and thereby improve some of these memory and cognitive deficits. Six patients with DLB will have bilateral electrodes implanted to ensure that superficial contacts lie in the conventional motor GPi target part of the brain, while the deepest electrical contacts lie in the NBM. All other aspects of the surgery will be identical to routine GPi Deep Brain Stimulation which we perform on a weekly basis in the NHS for Parkinson’s disease. We will place electrodes using our conventional image guided, stereotactic frame-based procedure currently used in patients at the National Hospital for Neurology & Neurosurgery. 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 1 month washout period, following which the patient will cross over to have the opposite condition for a further 6 weeks - see timeline. 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.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
13/EE/0391
Date of REC Opinion
21 Nov 2013
REC opinion
Further Information Favourable Opinion