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Nucleus Basalis Deep Brain Stimulation for Thinking & Memory Problems in Parkinson's.

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ClinicalTrials.gov Identifier: NCT01701544
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
University College, London

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dementia in Parkinson's Disease Device: NBM DBS Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : August 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: NBM DBS Off
NBM DBS switched off
 Device: NBM DBS
Deep Brain Stimulation targeting the Nucleus Basalis of Meynert
Active Comparator: NBM DBS On
NBM DBS Switched On
 Device: NBM DBS
Deep Brain Stimulation targeting the Nucleus Basalis of Meynert


Outcome Measures
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Primary Outcome Measures :
  1. Abbreviated cognitive battery [ 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



Secondary Outcome Measures :
  1. Minimental State Examination [ Time Frame: 6 months ]
  2. DRS-2 [ Time Frame: 6 months ]
    Dementia Rating Scale-2

  3. SRM (Faces) [ Time Frame: 6 months ]
    Short Recognition Memory for faces

  4. WAIS-III (Letter number sequencing, Arithmetic) [ Time Frame: 6 months ]
    Wechsler Abbreviated Scale of Intelligence

  5. FAST [ Time Frame: 6 months ]
    Florida Apraxia Screening test

  6. NPI [ Time Frame: 6 months ]
    Neuropsychiatric Inventory

  7. BDS [ Time Frame: 6 months ]
    Blessed Dementia Scale

  8. HAM-D [ Time Frame: 6 months ]
    Hamilton Depression scale

  9. MDS UPDRS [ Time Frame: 6 months ]
    Movement Disorders Society - Unified Parkinson's disease Rating scale

  10. PDQ39 [ Time Frame: 6 months ]
    Parkinson's disease quality of life questionnaire

  11. GFQ [ Time Frame: 6 months ]
    Gait and falls questioannaire

  12. NMS Quest [ Time Frame: 6 months ]
    Non Motor Symptoms Questionnaire


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients will meet Queen Square brain bank criteria for the diagnosis of PD and will have motor fluctuations (off periods and/or L-dopa induced dyskinesias) in response to medications that are known to improve with GPi DBS, and will be appropriate candidates for GPi DBS aside from the coexistence of cognitive impairment.

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:

  • Diagnosis or suspicion of other cause for parkinsonism or dementia.

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701544


Locations
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United Kingdom
National Hospital for Neurology & Neurosurgery
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Thomas Foltynie, PhD UCL Institute of Neurology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01701544     History of Changes
Other Study ID Numbers: 11/0516
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases