TEND Study:Telemedicine Nurse DBS for Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Telemedicine Nurse DBS for Parkinson's Disease: The TEND Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04677621
• Other study ID #: IRB202002994-N
• Secondary ID: OCR39945PRO00042
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Parkinson Disease

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