AzTrials
AzTrials

Dementia in Parkinson's DiseasePhase 1/2NCT01701544

Nucleus Basalis Deep Brain Stimulation for Thinking & Memory Problems in Parkinson's.

A Phase 1/2 study testing NBM DBS in people with Dementia in Parkinson's Disease, run by University College, London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

We will perform a pilot study to evaluate the effectiveness of human NBM DBS at improving cognitive deficits in PD patients referred and eligible for conventional DBS treatment for coexisting motor impairments. Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Dementia in Parkinson's Disease
What is being tested?
NBM DBS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6 participants
Where
1 siteUnited Kingdom
Study dates
Aug 2012to Dec 2015
Phase
Phase 1/2
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 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients will meet Queen Square brain bank criteria for the diagnosis of PD and will have motor fluctuations (off periods and/or L-dopa induced dyskinesias) in response to medications that are known to improve with GPi DBS, and will be appropriate candidates for GPi DBS aside from the coexistence of cognitive impairment.
  • Patients will be aged between 35 and 80 years.
  • Patients will be able to give informed consent.
  • Patients will meet criteria for PD dementia. Patients will have a MMSE score between 26 and lower cutoff of 21 to restrict the sample to those with mild dementia and cognitive impairment. This will be equivalent to an age and education adjusted scaled score of greater than 5 and lower than 9 (mildly impaired range) on the Mattis Dementia Rating Scale-2.
  • Patients will have only minimal atrophy on pre-operative brain MRI scans.
  • Patients will be living at home and will have a carer living with them e.g. their spouse
  • Able to comply with trial protocol and willing to attend clinic necessary visits

Who cannot join

  • Diagnosis or suspicion of other cause for parkinsonism or dementia.
  • Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol.
  • Prior intra-cerebral surgical intervention for Parkinson's disease including Deep Brain stimulation, lesional surgery, growth factor administration, gene therapy or cell transplant.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • National Hospital for Neurology & Neurosurgery

    London, WC1N 3BG

Other trials in United Kingdom

About this study

Official title: Double Blind, Randomised, Single Centre, Crossover Pilot Trial of Bilateral Nucleus Basalis of Meynert Deep Brain Stimulation to Improve Cognitive Deficits in Patients With Parkinson's Disease.

We will perform a pilot study to evaluate the effectiveness of human NBM DBS at improving cognitive deficits in PD patients referred and eligible for conventional DBS treatment for coexisting motor impairments. Six patients with PD with both motor fluctuations and cognitive impairments (including but not restricted to deficits in attention and working memory) will have bilateral electrodes implanted to ensure that superficial contacts lie in the conventional motor GPi target, while the deepest electrical contacts lie in the NBM- (see figure 1). We will place electrodes using our conventional image guided, stereotactic frame-based procedure currently used in patients at NHNN. Patients will be randomised into 2 groups in a crossover trial design to have 3 month periods of NBM stimulation switched on or switched off separated by a 1 month washout period, following which the patient will cross over to have the opposite condition for a further 3 months- see timeline. 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.

Being tested
NBM DBS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NBM DBSDevice

    Deep Brain Stimulation targeting the Nucleus Basalis of Meynert

Study groups in NCT01701544
Study groupRoleWhat they receive
NBM DBS OffSham comparatorNBM DBS switched off
Receives: Device: NBM DBS
NBM DBS OnActive comparatorNBM DBS Switched On
Receives: Device: NBM DBS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Abbreviated cognitive battery

    Differences between each item of the abbreviated cognitive battery scores between patients after 3 months ON stimulation and 3 months OFF stimulation.

    CVLT-II,Verbal Fluency,Simple \& Choice RT (CANTAB),Digit span,Posner's covert attention test

    Measured: 6 months

Secondary outcomes (12)

  1. Minimental State Examination

    Measured: 6 months

  2. DRS-2

    Dementia Rating Scale-2

    Measured: 6 months

  3. SRM (Faces)

    Short Recognition Memory for faces

    Measured: 6 months

  4. WAIS-III (Letter number sequencing, Arithmetic)

    Wechsler Abbreviated Scale of Intelligence

    Measured: 6 months

  5. FAST

    Florida Apraxia Screening test

    Measured: 6 months

  6. NPI

    Neuropsychiatric Inventory

    Measured: 6 months

  7. BDS

    Blessed Dementia Scale

    Measured: 6 months

  8. HAM-D

    Hamilton Depression scale

    Measured: 6 months

  9. MDS UPDRS

    Movement Disorders Society - Unified Parkinson's disease Rating scale

    Measured: 6 months

  10. PDQ39

    Parkinson's disease quality of life questionnaire

    Measured: 6 months

  11. GFQ

    Gait and falls questioannaire

    Measured: 6 months

  12. NMS Quest

    Non Motor Symptoms Questionnaire

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01701544
Sponsor's protocol ID
11/0516
Status last verified
Oct 2016
First submitted
3 Oct 2012
Last updated
31 Oct 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Gratwicke J, Zrinzo L, Kahan J, Peters A, Beigi M, Akram H, Hyam J, Oswal A, Day B, Mancini L, Thornton J, Yousry T, Limousin P, Hariz M, Jahanshahi M, Foltynie T. Bilateral Deep Brain Stimulation of the Nucleus Basalis of Meynert for Parkinson Disease Dementia: A Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):169-178. doi: 10.1001/jamaneurol.2017.3762.

    PubMed 29255885

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NBM DBS in people with Dementia in Parkinson's Disease, run by University College, London at 1 site 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 7 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 1 site 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Abbreviated cognitive battery (time frame: 6 months). 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 NCT01701544, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in