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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01701544
First received: October 3, 2012
Last updated: January 21, 2013
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Dementia in Parkinson's Disease
 Device: NBM DBS
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University College, London:

Primary Outcome Measures:
  • Abbreviated cognitive battery [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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:
  • Minimental State Examination [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • DRS-2 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Dementia Rating Scale-2

  • SRM (Faces) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Short Recognition Memory for faces

  • WAIS-III (Letter number sequencing, Arithmetic) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Wechsler Abbreviated Scale of Intelligence

  • FAST [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Florida Apraxia Screening test

  • NPI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Neuropsychiatric Inventory

  • BDS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Blessed Dementia Scale

  • HAM-D [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Hamilton Depression scale

  • MDS UPDRS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Movement Disorders Society - Unified Parkinson's disease Rating scale

  • PDQ39 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Parkinson's disease quality of life questionnaire

  • GFQ [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Gait and falls questioannaire

  • NMS Quest [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Non Motor Symptoms Questionnaire


Estimated Enrollment: 6
Study Start Date: August 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701544

Locations
United Kingdom
National Hospital for Neurology & Neurosurgery
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Thomas Foltynie, PhD UCL Institute of Neurology
  More Information

No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01701544     History of Changes
Other Study ID Numbers: 11/0516
Study First Received: October 3, 2012
Last Updated: January 21, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Dementia
Parkinson Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
 Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 19, 2013