Status:
WITHDRAWN
TEND Study:Telemedicine Nurse DBS for Parkinson's Disease
Lead Sponsor:
University of Florida
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The central hypothesis is that home health nurses can improve access and provide high quality care when guided by a sophisticated platform that integrates bioinformatics, patient-specific computationa...
Eligibility Criteria
Inclusion
- Pre-operative A good response to levodopa is required in order to exclude patients with Parkinson's plus syndromes, and will be defined as a 30% improvement in parkinsonian motor signs based upon the Unified PD Rating Scale (UPDRS) motor examination subscore, following the administration of 1.5 times the typical dopaminergic dose during the screening neurological examination. Patients must also have PD for a minimum of 5 years duration.
- Additional inclusion criteria consist of: 1) Hoehn \& Yahr stage II or worse when off; 2) Intractable, disabling motor fluctuations and/or tremor; 3) Age between 30-75 years; 4) Unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of antiparkinsonian drugs). 5) A stable/optimal medical regimen of antiparkinsonian drug therapy for at least one month prior to surgery; 6) access to high-speed internet in the home.
Exclusion
- Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g. significant cardiac or pulmonary disease, uncontrolled hypertension).
- Evidence of secondary or atypical parkinsonism.
- MRI scan with significant evidence of brain atrophy or other abnormalities.
- Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.
- A major untreated psychiatric disorder.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04677621
Start Date
January 1 2023
End Date
May 15 2023
Last Update
June 8 2023
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