Imaging Blood Brain Imaging Dysfunction in Parkinson's Disease

NCT02605161 | Completed

• 1 other identifier: 20150770-01H
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the blood brain barrier in the striatum of patients that have other types of movement disorders compared to patients with Parkinson's Disease that are receiving similar treatment, to determine if a there is a disruption of the blood brain barrier in patients with Parkinson's Disease.

Conditions

Parkinson's Disease; Movement Disorders

Keywords

Blood brain barrier; movement disorder; deep brain stimulation; essential tremor; cervical dystonia; magnetic resonance imaging; neostriatum

Outcome Measures

Primary Outcomes (1)

• Degree of contrast enhancement

  Pre-contrast images will be used as mask images and will be digitally substracted from post-contrast images to obtain the "difference" images. From the "difference images", two neuroradiologists blinded to the clinical status of the patient will assess the degree enhancement in the striatum (none,mild, moderate, marked).

  one year

Secondary Outcomes (1)

• Permeability of blood brain barrier in the striatum

  one year

Study Arms (2)

Parkinson's disease group

* patients diagnosed with Parkinson's disease by a movement disorder specialist from the deep brain stimulation program at The Ottawa Hospital, Civic Campus * to undergo pre-operative MRI with contrast

Control group

* patients diagnosed with either essential tremor or cervical dystonia by a movement disorder specialist from the deep brain stimulation program at The Ottawa Hospital, Civic Campus * to undergo pre-operative MRI with contrast

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients having movement disorders undergoing deep brain stimulation (DBS) of the internal segment of the globus pallidus for treatment of motor symptoms refractory to medical therapy at the Ottawa Hospital, Civic Campus, will be recruited to participate in this pilot study. The cohort will include 10 PD patients and 10 control subjects. The PD subjects will have received a diagnosis of PD using established clinical criteria following clinical assessment at the Movement Disorders Clinic of The Ottawa Hospital. The 10 control subjects will consist of those undergoing DBS and assessed in the same clinic with a clinical diagnosis of either essential tremor or cervical dystonia.

You may qualify if:

• Disease burden is dominated by motor symptoms such as rigidity, bradykinesia, akinesia, and tremor;
• Medications have been optimized by a movement disorder neurologist;
• Adequate social support to assist with preoperative recovery and problems during subsequent programming;
• No major mood disorder and any mood disorders are medically optimized;
• No major cognitive impairment;
• No underlying medical conditions that would preclude surgery;
• Adequate response to levodopa, as assessed by UPDRS-3 on and off levodopa. All participants has at least a 30% improvement;
• eGRF\>30

You may not qualify if:

• Disease burden is not dominated by motor symptoms such as rigidity, bradykinesia, akinesia, and tremor;
• Medications have not bee optimized by a movement disorder neurologist;
• There is not adequate social support to assist with pre-operative recovery or problems during subsequent programming;
• Presence of major mood disorders or any mood disorders not medically optimized;
• Presence of major cognitive impairment;
• Presence of underlying medical conditions that would preclude surgery;
• Inadequate response to levodopa;
• eGFR\<30

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y1J7, Canada

Location

Related Publications (4)

• Warner TT, Schapira AH. Genetic and environmental factors in the cause of Parkinson's disease. Ann Neurol. 2003;53 Suppl 3:S16-23; discussion S23-5. doi: 10.1002/ana.10487.

  PMID: 12666095 BACKGROUND

• Gray MT, Woulfe JM. Striatal blood-brain barrier permeability in Parkinson's disease. J Cereb Blood Flow Metab. 2015 May;35(5):747-50. doi: 10.1038/jcbfm.2015.32. Epub 2015 Mar 11.

  PMID: 25757748 BACKGROUND

• Schulz-Schaeffer WJ. The synaptic pathology of alpha-synuclein aggregation in dementia with Lewy bodies, Parkinson's disease and Parkinson's disease dementia. Acta Neuropathol. 2010 Aug;120(2):131-43. doi: 10.1007/s00401-010-0711-0. Epub 2010 Jun 20.

  PMID: 20563819 BACKGROUND

• Orr CF, Rowe DB, Mizuno Y, Mori H, Halliday GM. A possible role for humoral immunity in the pathogenesis of Parkinson's disease. Brain. 2005 Nov;128(Pt 11):2665-74. doi: 10.1093/brain/awh625. Epub 2005 Oct 11.

  PMID: 16219675 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders; Essential Tremor; Torticollis

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thanh B Nguyen, MD, FRCP

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 16, 2015
• Study Start: November 1, 2015
• Primary Completion: September 8, 2020
• Study Completion: September 8, 2020
• Last Updated: December 31, 2020

Record last verified: 2020-12

Locations

CA (1)