Dementia With Lewy BodiesNCT02263937
Deep Brain Stimulation for Patients With Dementia With Lewy Bodies
A study testing Bilateral Nucleus Basalis Meynert DBS in people with Dementia With Lewy Bodies, run by University College, London at 2 sites in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Dementia With Lewy Bodies
- What is being tested?
- Bilateral Nucleus Basalis Meynert DBS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Living at home with Carer
- Able to comply with protocol
- On stable dosage of cholinesterase inhibitor
Who cannot join
- Diagnosis of other cause for dementia
- Abnormality on brain imaging considered likely to compromise compliance with trial protocol.
- Prior intracerebral surgical intervention
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
UCL Institute of Neurology
London, WC1N 3BG
University of Newcastle
Newcastle
About this study
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.
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).
Read the 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.
- Conditions
- Dementia With Lewy Bodies
- Being tested
- Bilateral Nucleus Basalis Meynert DBS, Sham Nucleus Basalis Meynert DBS
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Nucleus Basalis Meynert DBSProcedure or surgery
Also called Active Deep Brain Stimulation
Low frequency stimulation applied using standard Deep brain stimualtion hardware.
Sham Nucleus Basalis Meynert DBSProcedure or surgery
Also called Sham DBS
DBS system switched off.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Nucleus Basalis Meynert DBS | Active comparator | 6 week period of active NBM DBS Receives: Procedure: Bilateral Nucleus Basalis Meynert DBS |
| Sham Nucleus Basalis Meynert DBS | Sham comparator | 6 week period of Sham DBS Receives: Procedure: Sham Nucleus Basalis Meynert DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hopkins Verbal Learning test
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Verbal Fluency
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Simple & Choice Reaction time task
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Wechsler Adult Intelligence scale (WAIS IV) Digit Span
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Posner's Covert Attention test
Measured: Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status
Clinician's Assessment of Fluctuations scale
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Secondary outcomes (24)
Minimental State Examination (MMSE)
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Dementia Rating Scale (DRS-2)
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Wechsler Abbreviated Scale of Intelligence (WASI)
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Short Recognition Memory
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Wechsler Adult Intelligence Scale IV -Letter, Number sequencing
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Trail Making test
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Stroop test
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Wechsler Adult Intelligence Scale IV - Symbol search
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Judgement of Line Orientation
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
North East Visual Hallucinations Interview
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Neuropsychiatric Inventory
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Florida Apraxia Screening test
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Clinical Global Impression Scale
Measured: Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status
Hamilton Depression scale
Measured: Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status
Hamilton Anxiety Scale
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Starkstein Apathy Rating scale
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Movement Disorders Society- Unified Parkinson's Disease Rating Scale
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Freezing of Gait- questionnaire
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Scales for outcome in Parkinson's disease (SCOPA - AUT)
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Quality of Life- Alzheimer's Disease
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Mayo Fluctuations Composite Scale
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Blessed Dementia scale
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Carer Strain Index
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Short Form 36
Measured: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia With Lewy BodiesStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Foltynie, MB BS MRCP, Principal investigator, UCL Institute of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263937
- Sponsor's protocol ID
- 13/0538
- Status last verified
- Oct 2016
- First submitted
- 30 Sep 2014
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32334074
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02263937
- Acronym / sponsor ID
- 13/0538
- Conditions
- Dementia With Lewy Bodies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral Nucleus Basalis Meynert DBS | Active comparator | Procedure: Bilateral Nucleus Basalis Meynert DBS6 week period of active NBM DBS |
| Sham Nucleus Basalis Meynert DBS | Sham comparator | Procedure: Sham Nucleus Basalis Meynert DBS6 week period of Sham DBS |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Diagnosis of other cause for dementia
- Abnormality on brain imaging considered likely to compromise compliance with trial protocol.
- Prior intracerebral surgical intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Nucleus Basalis Meynert DBSAlso: Active Deep Brain StimulationLow frequency stimulation applied using standard Deep brain stimualtion hardware. | Procedure or surgery | Bilateral Nucleus Basalis Meynert DBS |
| Sham Nucleus Basalis Meynert DBSAlso: Sham DBSDBS system switched off. | Procedure or surgery | Sham Nucleus Basalis Meynert DBS |
Primary outcome
Hopkins Verbal Learning test
Time frame: 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
Simple & Choice Reaction time task
Time frame: 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
Posner's Covert Attention test
Time frame: 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
24 secondary outcomes
Minimental State Examination (MMSE)
Time frame: 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
Wechsler Abbreviated Scale of Intelligence (WASI)
Time frame: 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
Wechsler Adult Intelligence Scale IV -Letter, Number sequencing
Time frame: 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
Stroop test
Time frame: 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
Judgement of Line Orientation
Time frame: 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
Neuropsychiatric Inventory
Time frame: 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
Clinical Global Impression Scale
Time frame: 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
Hamilton Anxiety Scale
Time frame: 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
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
Freezing of Gait- questionnaire
Time frame: 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
Quality of Life- Alzheimer's Disease
Time frame: 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
Blessed Dementia scale
Time frame: 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
Short Form 36
Time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Derived from this study: PubMed 32334074Gratwicke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Foltynie, MB BS MRCP principal investigator
UCL Institute of Neurology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Nucleus Basalis Meynert DBS in people with Dementia With Lewy Bodies, run by University College, London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hopkins Verbal Learning test (time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02263937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.