- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01701544
Nucleus Basalis Deep Brain Stimulation for Thinking & Memory Problems in Parkinson's.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, WC1N 3BG
- National Hospital for Neurology & Neurosurgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: NBM DBS Off
NBM DBS switched off
|
Deep Brain Stimulation targeting the Nucleus Basalis of Meynert
|
Active Comparator: NBM DBS On
NBM DBS Switched On
|
Deep Brain Stimulation targeting the Nucleus Basalis of Meynert
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abbreviated cognitive battery
Time Frame: 6 months
|
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 |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minimental State Examination
Time Frame: 6 months
|
6 months
|
|
DRS-2
Time Frame: 6 months
|
Dementia Rating Scale-2
|
6 months
|
SRM (Faces)
Time Frame: 6 months
|
Short Recognition Memory for faces
|
6 months
|
WAIS-III (Letter number sequencing, Arithmetic)
Time Frame: 6 months
|
Wechsler Abbreviated Scale of Intelligence
|
6 months
|
FAST
Time Frame: 6 months
|
Florida Apraxia Screening test
|
6 months
|
NPI
Time Frame: 6 months
|
Neuropsychiatric Inventory
|
6 months
|
BDS
Time Frame: 6 months
|
Blessed Dementia Scale
|
6 months
|
HAM-D
Time Frame: 6 months
|
Hamilton Depression scale
|
6 months
|
MDS UPDRS
Time Frame: 6 months
|
Movement Disorders Society - Unified Parkinson's disease Rating scale
|
6 months
|
PDQ39
Time Frame: 6 months
|
Parkinson's disease quality of life questionnaire
|
6 months
|
GFQ
Time Frame: 6 months
|
Gait and falls questioannaire
|
6 months
|
NMS Quest
Time Frame: 6 months
|
Non Motor Symptoms Questionnaire
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Foltynie, PhD, UCL Institute of Neurology
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11/0516
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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