National Hospital for Neurology & Neurosurgery
London, WC1N 3BG, United Kingdom
NCT Number: NCT01701544
We will perform a pilot study to evaluate the effectiveness of human NBM DBS at improving cognitive deficits in PD patients referred and eligible for conventional DBS treatment for coexisting motor impairments. Six patients with PD with both motor fluctuations and cognitive impairments (including but not restricted to deficits in attention and working memory) will have bilateral electrodes implanted to ensure that superficial contacts lie in the conventional motor GPi target, while the deepest electrical contacts lie in the NBM- (see figure 1). We will place electrodes using our conventional image guided, stereotactic frame-based procedure currently used in patients at NHNN. Patients will be randomised into 2 groups in a crossover trial design to have 3 month 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 3 months- 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. 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.
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Notify Me35 year–80 year
All sexes
Interventional
Phase 1 / Phase 2
London, WC1N 3BG, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients will be aged between 35 and 80 years.
Patients will be able to give informed consent.
Patients will meet criteria for PD dementia. Patients will have a MMSE score between 26 and lower cutoff of 21 to restrict the sample to those with mild dementia and cognitive impairment. This will be equivalent to an age and education adjusted scaled score of greater than 5 and lower than 9 (mildly impaired range) on the Mattis Dementia Rating Scale-2.
Patients will have only minimal atrophy on pre-operative brain MRI scans.
Patients will be living at home and will have a carer living with them e.g. their spouse
Able to comply with trial protocol and willing to attend clinic necessary visits
Exclusion criteria
Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol.
Prior intra-cerebral surgical intervention for Parkinson's disease including Deep Brain stimulation, lesional surgery, growth factor administration, gene therapy or cell transplant.
Deep Brain Stimulation targeting the Nucleus Basalis of Meynert
Time frame: 6 months
Differences between each item of the abbreviated cognitive battery scores between patients after 3 months ON stimulation and 3 months OFF stimulation.
CVLT-II,Verbal Fluency,Simple & Choice RT (CANTAB),Digit span,Posner's covert attention test
Time frame: 6 months
Time frame: 6 months
Dementia Rating Scale-2
Time frame: 6 months
Short Recognition Memory for faces
Time frame: 6 months
Wechsler Abbreviated Scale of Intelligence
Time frame: 6 months
Florida Apraxia Screening test
Time frame: 6 months
Neuropsychiatric Inventory
Time frame: 6 months
Blessed Dementia Scale
Time frame: 6 months
Hamilton Depression scale
Time frame: 6 months
Movement Disorders Society - Unified Parkinson's disease Rating scale
Time frame: 6 months
Parkinson's disease quality of life questionnaire
Time frame: 6 months
Gait and falls questioannaire
Time frame: 6 months
Non Motor Symptoms Questionnaire
University College, London
Other
Double Blind, Randomised, Single Centre, Crossover Pilot Trial of Bilateral Nucleus Basalis of Meynert Deep Brain Stimulation to Improve Cognitive Deficits in Patients With Parkinson's Disease.
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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.