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Completed

NCT Number: NCT02263937

Deep Brain Stimulation for Patients With Dementia With Lewy Bodies

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).

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCL Institute of Neurology, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Bilateral Nucleus Basalis Meynert DBS

Procedure

Low frequency stimulation applied using standard Deep brain stimualtion hardware.

Other names: Active Deep Brain Stimulation

Sham Nucleus Basalis Meynert DBS

Procedure

DBS system switched off.

Other names: Sham DBS

Primary outcomes

  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 outcomes

  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 outcomes

  1. Adverse Events

    Time frame: Throughout trial period

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 13, 2014
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.

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