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Deep Brain Stimulation for Patients With Dementia With Lewy Bodies

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ClinicalTrials.gov Identifier: NCT02263937
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
University College, London

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Dementia With Lewy Bodies Procedure: Bilateral Nucleus Basalis Meynert DBS Procedure: Sham Nucleus Basalis Meynert DBS Not Applicable

Detailed Description:

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.

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, 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.
Study Start Date : January 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Bilateral Nucleus Basalis Meynert DBS
6 week period of active NBM DBS
 Procedure: Bilateral Nucleus Basalis Meynert DBS
Low frequency stimulation applied using standard Deep brain stimualtion hardware.
Other Name: Active Deep Brain Stimulation
Sham Comparator: Sham Nucleus Basalis Meynert DBS
6 week period of Sham DBS
 Procedure: Sham Nucleus Basalis Meynert DBS
DBS system switched off.
Other Name: Sham DBS


Outcome Measures
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Primary Outcome Measures :
  1. Hopkins Verbal Learning test [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  2. Verbal Fluency [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  3. Simple & Choice Reaction time task [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  4. Wechsler Adult Intelligence scale (WAIS IV) Digit Span [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  5. Posner's Covert Attention test [ Time Frame: Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status ]
  6. Clinician's Assessment of Fluctuations scale [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]

Secondary Outcome Measures :
  1. Minimental State Examination (MMSE) [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  2. Dementia Rating Scale (DRS-2) [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  3. Wechsler Abbreviated Scale of Intelligence (WASI) [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  4. Short Recognition Memory [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  5. Wechsler Adult Intelligence Scale IV -Letter, Number sequencing [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  6. Trail Making test [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  7. Stroop test [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  8. Wechsler Adult Intelligence Scale IV - Symbol search [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  9. Judgement of Line Orientation [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  10. North East Visual Hallucinations Interview [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  11. Neuropsychiatric Inventory [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  12. Florida Apraxia Screening test [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  13. Clinical Global Impression Scale [ Time Frame: Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status ]
  14. Hamilton Depression scale [ Time Frame: Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status ]
  15. Hamilton Anxiety Scale [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  16. Starkstein Apathy Rating scale [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  17. Movement Disorders Society- Unified Parkinson's Disease Rating Scale [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  18. Freezing of Gait- questionnaire [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  19. Scales for outcome in Parkinson's disease (SCOPA - AUT) [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  20. Quality of Life- Alzheimer's Disease [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  21. Mayo Fluctuations Composite Scale [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  22. Blessed Dementia scale [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  23. Carer Strain Index [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]
  24. Short Form 36 [ Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status ]

Other Outcome Measures:
  1. Adverse Events [ Time Frame: Throughout trial period ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DLB Consortium Criteria for diagnosis
  • Score between 2 & 12 on Clinician Assessment of Fluctuations scale
  • MMSE score between 21 and 27
  • Appropriate Surgical candidates in terms of general health
  • Aged between 50 & 80
  • Able to give Informed consent
  • Living at home with Carer
  • Able to comply with protocol
  • On stable dosage of cholinesterase inhibitor

Exclusion Criteria:

  • Diagnosis of other cause for dementia
  • Abnormality on brain imaging considered likely to compromise compliance with trial protocol.
  • Prior intracerebral surgical intervention
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): NCT02263937


Locations
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United Kingdom
UCL Institute of Neurology
London, United Kingdom, WC1N 3BG
University of Newcastle
Newcastle, United Kingdom
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Thomas Foltynie, MB BS MRCP 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: NCT02263937    
Other Study ID Numbers: 13/0538
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Dementia
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
 Mental Disorders
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Synucleinopathies