Bilateral Nucleus Basalis Meynert DBS
ProcedureLow frequency stimulation applied using standard Deep brain stimualtion hardware.
Other names: Active Deep Brain Stimulation
NCT Number: NCT02263937
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).
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Notify Me50 year–80 year
All sexes
Interventional
Not applicable
UCL Institute of Neurology, London, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Low frequency stimulation applied using standard Deep brain stimualtion hardware.
Other names: Active Deep Brain Stimulation
DBS system switched off.
Other names: Sham DBS
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Time frame: Throughout trial period
University College, London
Other
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.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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