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Deep Brain Stimulation for Patients With Dementia With Lewy Bodies

NCT ID: NCT02263937

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Dementia With Lewy Bodies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Bilateral Nucleus Basalis Meynert DBS

6 week period of active NBM DBS

Group Type ACTIVE_COMPARATOR

Bilateral Nucleus Basalis Meynert DBS

Intervention Type PROCEDURE

Low frequency stimulation applied using standard Deep brain stimualtion hardware.

Sham Nucleus Basalis Meynert DBS

6 week period of Sham DBS

Group Type SHAM_COMPARATOR

Sham Nucleus Basalis Meynert DBS

Intervention Type PROCEDURE

DBS system switched off.

Interventions

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Bilateral Nucleus Basalis Meynert DBS

Low frequency stimulation applied using standard Deep brain stimualtion hardware.

Intervention Type PROCEDURE

Sham Nucleus Basalis Meynert DBS

DBS system switched off.

Intervention Type PROCEDURE

Other Intervention Names

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Active Deep Brain Stimulation Sham DBS

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Foltynie, MB BS MRCP

Role: PRINCIPAL_INVESTIGATOR

UCL Institute of Neurology

Locations

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UCL Institute of Neurology

London, , United Kingdom

Site Status

University of Newcastle

Newcastle, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Gratwicke J, Zrinzo L, Kahan J, Peters A, Brechany U, McNichol A, Beigi M, Akram H, Hyam J, Oswal A, Day B, Mancini L, Thornton J, Yousry T, Crutch SJ, Taylor JP, McKeith I, Rochester L, Schott JM, Limousin P, Burn D, Rossor MN, Hariz M, Jahanshahi M, Foltynie T. Bilateral nucleus basalis of Meynert deep brain stimulation for dementia with Lewy bodies: A randomised clinical trial. Brain Stimul. 2020 Jul-Aug;13(4):1031-1039. doi: 10.1016/j.brs.2020.04.010. Epub 2020 Apr 22.

Reference Type DERIVED
PMID: 32334074 (View on PubMed)

Other Identifiers

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13/0538

Identifier Type: -

Identifier Source: org_study_id