Status:
WITHDRAWN
Combined Deep Brain Stimulation for Parkinson's Disease
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson Disease
Eligibility:
All Genders
22+ years
Phase:
PHASE1
PHASE2
Brief Summary
Background: \- Deep brain stimulation (DBS) in the subthalamic nucleus (STN) is an approved treatment for Parkinson s disease. It stimulates a part of the brain that helps control symptoms like tremo...
Detailed Description
OBJECTIVE: 1. Determine if bilateral Pedunculo-Pontine Nucleus (PPN) Deep Brain Stimulation (DBS) will improve gait and balance problems in Parkinson Disease (PD) patients whose other disease feature...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- i. Greater than 22 years of age
- ii. Successful bilateral STN DBS implants for at least 1 year
- iii. At least 30% improvement in the motor UPDRS following STN therapy, by history and record review
- iv. Improved UPDRS and self assessment questionnaire following STN DBS by at least 20%, by history and record review.
- v. Good STN DBS placement assessed with imaging (CT scan, MRI or fused CT-MRI imaging)
- vii. Persistent gait disturbance as ascertained by abnormal performance on the time-up-and-go test compared to age-matched controls as well as preoperative evaluation with posturography and quantitative gait assessment (values compared to normal age-matched controls) at least 30% difference from age-matched controls on either measure.
- vii. Persistent speech and swallowing problems as measured by a minimum score of I in items 5 and 7 of the UPDRS
- viii. Evaluation by an independent movement disorders specialist who will confirm gait disturbance in the presence of STN stimulation.
- EXCLUSION CRITERIA:
- i. Pregnant or nursing women
- ii. Cognitively impaired subjects as determined by pre-operative neuropsychology evaluation, including Mattis Dementia Rating Scale (DRS). Patients scoring below 70 on the Mattis DRS will be excluded.
- iii. Depressed subjects as determined by the neuropsychology screen, including Beck Depression Inventory. Patients scoring above 20 on the Beck inventory will be excluded.
- iv. Patients with uncontrolled co-existing medical conditions: uncontrolled systemic hypertension with values above 170/100; heart disease needing intervention; respiratory disease needing intervention; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.
- v. Patients with metal objects in their body that are not MRI compatible, excluding the previous STN DBS hardware
- vi. Patients who have a history of seizures, require repeated magnetic resonance imaging (MRI) scans or have had a cranial neurosurgical procedure since receiving an STN implant.
Exclusion
Key Trial Info
Start Date :
November 8 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01485276
Start Date
November 8 2011
End Date
July 30 2014
Last Update
November 15 2019
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