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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04677621
Other study ID # IRB202002994-N
Secondary ID OCR39945PRO00042
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 2023
Est. completion date May 15, 2023

Study information

Verified date June 2023
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 computational modeling, and continuous symptom measurement.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 15, 2023
Est. primary completion date May 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Pre-operative Inclusion Criteria: 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 Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nurse Telehealth
Subjects will receive nurse telehealth Mobile Decision Support System (MAP) DBS care
STANDARD DBS
Subjects will receive standard in-person clinic-based DBS care administered without the use of Mobile Decision Support System (MAP) DBS

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Florida

Outcome

Type Measure Description Time frame Safety issue
Other UPDRS scores Difference in UPDRS scores from baseline to 6-month time point. UPDRS scoring scale 0-very good to 100-bad 6-months
Primary The number of participant clinic visits The number of in-person clinic visits required for each participant during the 6-month post operative DBS period. 6 MONTHS from date of enrollment
Secondary PDQ-39 Scores Difference in PDQ-39 scores from baseline to the 6-month time point. PDQ summary index score 0-very good to 100 bad 6-months
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