Deep Brain Stimulation for Patients With Dementia With Lewy Bodies

Dementia With Lewy Bodies Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263937
• Other study ID #: 13/0538
• Status: Completed
• Phase: N/A
• First received: September 30, 2014
• Last updated: October 28, 2016
• Start date: January 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia
• Dementia With Lewy Bodies
• Lewy Body Disease

Intervention

Procedure:
• Bilateral Nucleus Basalis Meynert DBS
Low frequency stimulation applied using standard Deep brain stimualtion hardware.
• Sham Nucleus Basalis Meynert DBS
DBS system switched off.

Locations

Country	Name	City	State
United Kingdom	UCL Institute of Neurology	London
United Kingdom	University of Newcastle	Newcastle

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events		Throughout trial period	Yes
Primary	Hopkins Verbal Learning test		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Primary	Verbal Fluency		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Primary	Simple & Choice Reaction time task		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Primary	Wechsler Adult Intelligence scale (WAIS IV) Digit Span		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Primary	Posner's Covert Attention test		Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status	No
Primary	Clinician's Assessment of Fluctuations scale		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Minimental State Examination (MMSE)		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Dementia Rating Scale (DRS-2)		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Wechsler Abbreviated Scale of Intelligence (WASI)		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Short Recognition Memory		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Wechsler Adult Intelligence Scale IV -Letter, Number sequencing		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Trail Making test		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Stroop test		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Wechsler Adult Intelligence Scale IV - Symbol search		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Judgement of Line Orientation		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	North East Visual Hallucinations Interview		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Neuropsychiatric Inventory		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Florida Apraxia Screening test		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Clinical Global Impression Scale		Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Hamilton Depression scale		Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Hamilton Anxiety Scale		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Starkstein Apathy Rating scale		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Movement Disorders Society- Unified Parkinson's Disease Rating Scale		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Freezing of Gait- questionnaire		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Scales for outcome in Parkinson's disease (SCOPA - AUT)		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Quality of Life- Alzheimer's Disease		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Mayo Fluctuations Composite Scale		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Blessed Dementia scale		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Carer Strain Index		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No
Secondary	Short Form 36		Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status	No