NCT02263937

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

September 30, 2014

Last Update Submit

October 28, 2016

Conditions

Dementia With Lewy Bodies

Outcome Measures

Primary Outcomes (6)

  • Hopkins Verbal Learning test

    Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status

  • Verbal Fluency

    Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status

  • Simple & Choice Reaction time task

    Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status

  • Wechsler Adult Intelligence scale (WAIS IV) Digit Span

    Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status

  • Posner's Covert Attention test

    Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status

  • Clinician's Assessment of Fluctuations scale

    Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status

Secondary Outcomes (24)

  • Minimental State Examination (MMSE)

    Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status

  • Dementia Rating Scale (DRS-2)

    Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status

  • Wechsler Abbreviated Scale of Intelligence (WASI)

    Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status

  • Short Recognition Memory

    Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status

  • Wechsler Adult Intelligence Scale IV -Letter, Number sequencing

    Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status

  • +19 more secondary outcomes

Other Outcomes (1)

  • Adverse Events

    Throughout trial period

Study Arms (2)

Bilateral Nucleus Basalis Meynert DBS

ACTIVE COMPARATOR

6 week period of active NBM DBS

Procedure: Bilateral Nucleus Basalis Meynert DBS

Sham Nucleus Basalis Meynert DBS

SHAM COMPARATOR

6 week period of Sham DBS

Procedure: Sham Nucleus Basalis Meynert DBS

Interventions

Bilateral Nucleus Basalis Meynert DBSPROCEDURE

Low frequency stimulation applied using standard Deep brain stimualtion hardware.

Also known as: Active Deep Brain Stimulation
Bilateral Nucleus Basalis Meynert DBS
Sham Nucleus Basalis Meynert DBSPROCEDURE

DBS system switched off.

Also known as: Sham DBS
Sham Nucleus Basalis Meynert DBS

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCL Institute of Neurology

London, WC1N 3BG, United Kingdom

Location

University of Newcastle

Newcastle, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 32334074DERIVED

MeSH Terms

Conditions

Lewy Body Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Thomas Foltynie, MB BS MRCP

    UCL Institute of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 13, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

GB(2)