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Completed

NCT Number: NCT01701544

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

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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Key information

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Hospital for Neurology & Neurosurgery

London, WC1N 3BG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NBM DBS

Device

Deep Brain Stimulation targeting the Nucleus Basalis of Meynert

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 5, 2012
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.