Status:
WITHDRAWN
Convection-Enhanced Delivery to Study the Pathophysiology Underlying the Clinical Features of Parkinson s Disease
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Background: * Parkinson s disease (PD) is a progressive neurodegenerative disorder that affects the brain cells that make the chemical dopamine. The primary medical treatment for PD has been to use m...
Detailed Description
Objective: The objectives of this pilot study are to gain insight into the safety, feasibility and clinical effects of infusion of a temporary acting GABAA agonist (muscimol) by convection-enhanced de...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Diagnosed with idiopathic PD by UK criteria:
- Bradykinesia: At least one of the following:
- Muscular rigidity
- 4-6 Hz resting tremor
- Postural instability not caused by primary visual, vestibular, cerebellar or proprioceptive dysfunction
- Three or more required in addition to above for the diagnosis of idiopathic PD:
- Unilateral onset
- Rest tremor present
- Progressive disorder
- Persistent asymmetry affecting side of onset most
- Excellent response (70-100%) to levodopa
- Severe levodopa-induced chorea
- Levodopa response for 5 years or more
- Clinical course of ten years or more
- The above clinical features must not be due to trauma, brain tumor, infection, cerebrovascular disease, other known neurological disease (e.g., multiple system atrophy, progressive supranuclear palsy, striatonigral degeneration, Huntington s disease, Wilson s disease, hydrocephalus) or due to known drugs, chemicals or toxicants.
- Disability present despite optimal antiparkinsonian medication therapy.
- Unequivocal responsiveness to levodopa, based on the single-dose levodopa test (as described in the CAPIT and CAPSIT guidelines). In addition to a 33% or greater improvement in one of the timed tasks, a 30% or greater improvement in the UPDRS total motor score will be required to establish unequivocal responsiveness to levodopa.
- Patients must demonstrate at least 6 hours of non-on time and medication side-effects such as levodopa-induced dyskinesias or motor fluctuations.
- Neuropsychological evaluation does not indicate substantial depression or cognitive dysfunction.
- Able to provide proper Informed Consent.
- EXCLUSION CRITERIA:
- Presence of prominent oculomotor palsy, cerebellar signs, vocal cord paresis, orthostatic hypotension (\> 20 mm Hg drop on standing), pyramidal tract signs or amyotrophy.
- Presence of dementia (Clinical Dementia Rating Scale score \> 1.0 or Mini Mental Status Examination Score \< 25).
- Presence or history of psychosis, including if induced by anti-PD medications.
- Presence of untreated or suboptimally treated depression (Hamilton Depression Scale score \>10) or a history of a serious mood disorder (for example, requiring psychiatric hospitalization or a prior suicide attempt).
- Presence of substance (drug, alcohol) abuse.
- Presence of hypointensity in the striatum on T2-weighted MR-imaging.
- Contraindication to MR-imaging and/or gadolinium.
- Coagulopathy, anticoagulant therapy, low platelet count, or inability to temporarily stop any antithrombotic medication.
- Prior brain surgery, including gene therapy, radiofrequency ablation or deep brain stimulation.
- Male or female with reproductive capacity who is unwilling to use contraception throughout the study.
- History of stroke or poorly controlled cardiovascular disease.
- Uncontrolled hypertension or diabetes or any other acute or chronic medical condition that would increase the risks of a neurosurgical procedure.
- Clinically active infection, including acute or chronic scalp infection.
- Received investigational agent within 12 weeks prior to screening.
- Unable to comply with the procedures of the protocol, including frequent and prolonged follow-up.
- Baseline hematology, chemistry or coagulation values out of normal range unless not clinically significant with respect to surgery.
Exclusion
Key Trial Info
Start Date :
June 2 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00921128
Start Date
June 2 2009
End Date
September 1 2016
Last Update
October 6 2017
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