Nucleus Basalis Deep Brain Stimulation for Thinking & Memory Problems in Parkinson's.
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ClinicalTrials.gov Identifier: NCT01701544 |
Recruitment Status :
Completed
First Posted : October 5, 2012
Last Update Posted : October 31, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dementia in Parkinson's Disease | Device: NBM DBS | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
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. |
Study Start Date : | August 2012 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
---|---|
Sham Comparator: NBM DBS Off
NBM DBS switched off
|
Device: NBM DBS
Deep Brain Stimulation targeting the Nucleus Basalis of Meynert |
Active Comparator: NBM DBS On
NBM DBS Switched On
|
Device: NBM DBS
Deep Brain Stimulation targeting the Nucleus Basalis of Meynert |
- 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
- Minimental State Examination [ Time Frame: 6 months ]
- DRS-2 [ Time Frame: 6 months ]Dementia Rating Scale-2
- SRM (Faces) [ Time Frame: 6 months ]Short Recognition Memory for faces
- WAIS-III (Letter number sequencing, Arithmetic) [ Time Frame: 6 months ]Wechsler Abbreviated Scale of Intelligence
- FAST [ Time Frame: 6 months ]Florida Apraxia Screening test
- NPI [ Time Frame: 6 months ]Neuropsychiatric Inventory
- BDS [ Time Frame: 6 months ]Blessed Dementia Scale
- HAM-D [ Time Frame: 6 months ]Hamilton Depression scale
- MDS UPDRS [ Time Frame: 6 months ]Movement Disorders Society - Unified Parkinson's disease Rating scale
- PDQ39 [ Time Frame: 6 months ]Parkinson's disease quality of life questionnaire
- GFQ [ Time Frame: 6 months ]Gait and falls questioannaire
- NMS Quest [ Time Frame: 6 months ]Non Motor Symptoms Questionnaire

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Ages Eligible for Study: | 35 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701544
United Kingdom | |
National Hospital for Neurology & Neurosurgery | |
London, United Kingdom, WC1N 3BG |
Principal Investigator: | Thomas Foltynie, PhD | UCL Institute of Neurology |
Responsible Party: | University College, London |
ClinicalTrials.gov Identifier: | NCT01701544 |
Other Study ID Numbers: |
11/0516 |
First Posted: | October 5, 2012 Key Record Dates |
Last Update Posted: | October 31, 2016 |
Last Verified: | October 2016 |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |