Study Stopped
Lack of enrollment
Neurocognitive Effects of Bilateral STN Versus GPi DBS in Parkinson's Disease Patients With MCI
DBS
1 other identifier
interventional
13
1 country
1
Brief Summary
Purpose: This is a prospective single-center, randomized, patient and evaluator-blind clinical trial to compare the neurocognitive outcomes of globus pallidus interna (GPi) versus subthalamic nucleus (STN) deep brain stimulation (DBS) in Parkinson's disease (PD) patients with mild cognitive impairment (MCI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2013
Typical duration for not_applicable
1 active site
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
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
June 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFebruary 10, 2016
February 1, 2016
2.8 years
May 1, 2013
February 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neurocognitive Function
By focusing on patients with MCI, our primary aim will be to detect whether STN or GPi DBS incur target specific impacts on patients' subsequent neurocognitive function.Patients will undergo neuropsychological testing pre-operatively and again at six months post-operatively. Patient's will also undergo a Montreal Cognitive Assessment at specified intervals: pre-operatively, 3weeks, 6 weeks and 6 months post-operatively.
6 months post-operative
Secondary Outcomes (1)
Functional motor improvements
6 month post-operative
Study Arms (2)
Parkinson's patients with MCI
ACTIVE COMPARATORProcedure: deep brain stimulation surgery
Parkinson's patients without MCI
ACTIVE COMPARATORProcedure: deep brain stimulation surgery
Interventions
Eligibility Criteria
You may qualify if:
- clinical diagnosis of idiopathic Parkinson's disease
- deemed an appropriate candidate for DBS surgery
- Montreal Cognitive Assessment (MoCA) score \< 25
- Neuropsychological testing with the diagnosis of Mild Cognitive Impairment
You may not qualify if:
- no diagnosis of Parkinson's disease
- not appropriate for DBS surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barrow Neurological Institute / St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013, United States
Related Publications (7)
Weaver FM, Follett KA, Stern M, Luo P, Harris CL, Hur K, Marks WJ Jr, Rothlind J, Sagher O, Moy C, Pahwa R, Burchiel K, Hogarth P, Lai EC, Duda JE, Holloway K, Samii A, Horn S, Bronstein JM, Stoner G, Starr PA, Simpson R, Baltuch G, De Salles A, Huang GD, Reda DJ; CSP 468 Study Group. Randomized trial of deep brain stimulation for Parkinson disease: thirty-six-month outcomes. Neurology. 2012 Jul 3;79(1):55-65. doi: 10.1212/WNL.0b013e31825dcdc1. Epub 2012 Jun 20.
PMID: 22722632BACKGROUNDAarsland D, Zaccai J, Brayne C. A systematic review of prevalence studies of dementia in Parkinson's disease. Mov Disord. 2005 Oct;20(10):1255-63. doi: 10.1002/mds.20527.
PMID: 16041803BACKGROUNDRodriguez-Oroz MC, Obeso JA, Lang AE, Houeto JL, Pollak P, Rehncrona S, Kulisevsky J, Albanese A, Volkmann J, Hariz MI, Quinn NP, Speelman JD, Guridi J, Zamarbide I, Gironell A, Molet J, Pascual-Sedano B, Pidoux B, Bonnet AM, Agid Y, Xie J, Benabid AL, Lozano AM, Saint-Cyr J, Romito L, Contarino MF, Scerrati M, Fraix V, Van Blercom N. Bilateral deep brain stimulation in Parkinson's disease: a multicentre study with 4 years follow-up. Brain. 2005 Oct;128(Pt 10):2240-9. doi: 10.1093/brain/awh571. Epub 2005 Jun 23.
PMID: 15975946BACKGROUNDFollett KA, Weaver FM, Stern M, Hur K, Harris CL, Luo P, Marks WJ Jr, Rothlind J, Sagher O, Moy C, Pahwa R, Burchiel K, Hogarth P, Lai EC, Duda JE, Holloway K, Samii A, Horn S, Bronstein JM, Stoner G, Starr PA, Simpson R, Baltuch G, De Salles A, Huang GD, Reda DJ; CSP 468 Study Group. Pallidal versus subthalamic deep-brain stimulation for Parkinson's disease. N Engl J Med. 2010 Jun 3;362(22):2077-91. doi: 10.1056/NEJMoa0907083.
PMID: 20519680BACKGROUNDMayeux R, Saunders AM, Shea S, Mirra S, Evans D, Roses AD, Hyman BT, Crain B, Tang MX, Phelps CH. Utility of the apolipoprotein E genotype in the diagnosis of Alzheimer's disease. Alzheimer's Disease Centers Consortium on Apolipoprotein E and Alzheimer's Disease. N Engl J Med. 1998 Feb 19;338(8):506-11. doi: 10.1056/NEJM199802193380804.
PMID: 9468467BACKGROUNDHansson O, Buchhave P, Zetterberg H, Blennow K, Minthon L, Warkentin S. Combined rCBF and CSF biomarkers predict progression from mild cognitive impairment to Alzheimer's disease. Neurobiol Aging. 2009 Feb;30(2):165-73. doi: 10.1016/j.neurobiolaging.2007.06.009. Epub 2007 Jul 23.
PMID: 17646035BACKGROUNDPark H, Poo MM. Neurotrophin regulation of neural circuit development and function. Nat Rev Neurosci. 2013 Jan;14(1):7-23. doi: 10.1038/nrn3379.
PMID: 23254191BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francisco A Ponce, MD
Barrow Neurological Institute / St. Joseph's Hospital & Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2013
First Posted
June 6, 2013
Study Start
April 1, 2013
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
February 10, 2016
Record last verified: 2016-02