Deep Brain Stimulation for Patients With Dementia With Lewy Bodies

October 28, 2016 updated by: University College, London

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 3BG
        • UCL Institute of Neurology
      • Newcastle, United Kingdom
        • University of Newcastle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Sham DBS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Minimental State Examination (MMSE)
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Dementia Rating Scale (DRS-2)
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Wechsler Abbreviated Scale of Intelligence (WASI)
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Short Recognition Memory
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Wechsler Adult Intelligence Scale IV -Letter, Number sequencing
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Trail Making test
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Stroop test
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Wechsler Adult Intelligence Scale IV - Symbol search
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Judgement of Line Orientation
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
North East Visual Hallucinations Interview
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Neuropsychiatric Inventory
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Florida Apraxia Screening test
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Clinical Global Impression Scale
Time Frame: Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status
Hamilton Depression scale
Time Frame: Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status
Hamilton Anxiety Scale
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Starkstein Apathy Rating scale
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
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
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Freezing of Gait- questionnaire
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
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
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Quality of Life- Alzheimer's Disease
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Mayo Fluctuations Composite Scale
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Blessed Dementia scale
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Carer Strain Index
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Short Form 36
Time Frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status

Other Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: Throughout trial period
Throughout trial period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Principal Investigator: Thomas Foltynie, MB BS MRCP, UCL Institute of Neurology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

September 30, 2014

First Submitted That Met QC Criteria

October 10, 2014

First Posted (ESTIMATE)

October 13, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/0538

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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