TEND Study:Telemedicine Nurse DBS for Parkinson's Disease

Not Applicable

Withdrawn

• Conditions: Parkinson Disease
• Interventions: Other: Nurse Telehealth; Other: STANDARD DBS

• Registration Number: NCT04677621
• Lead Sponsor: University of Florida

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 computational modeling, and continuous symptom measurement.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-21
• Study Start: 2023-01
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-15
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nurse Telehealth Intervention	Nurse Telehealth	Allocated to tele-intervention
Standard Deep Brain Stimulation (DBS)	STANDARD DBS	Allocated to conventional approach

Primary Outcome Measures

Name	Time	Method
The number of participant clinic visits	6 MONTHS from date of enrollment	The number of in-person clinic visits required for each participant during the 6-month post operative DBS period.

Secondary Outcome Measures

Name	Time	Method
PDQ-39 Scores	6-months	Difference in PDQ-39 scores from baseline to the 6-month time point. PDQ summary index score 0-very good to 100 bad