TEND Study:Telemedicine Nurse DBS for Parkinson's Disease

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Nurse Telehealth; Other: STANDARD DBS

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nurse Telehealth Intervention; Allocated to tele-intervention	Other: Nurse Telehealth; Subjects will receive nurse telehealth Mobile Decision Support System (MAP) DBS care
Active Comparator: Standard Deep Brain Stimulation (DBS); Allocated to conventional approach	Other: STANDARD DBS; Subjects will receive standard in-person clinic-based DBS care administered without the use of Mobile Decision Support System (MAP) DBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
UPDRS scores	Difference in UPDRS scores from baseline to 6-month time point. UPDRS scoring scale 0-very good to 100-bad	6-months

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Michael Okun, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2023
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Home Health
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: IRB202002994-N; OCR39945 (Other Identifier: UF OnCore); PRO00042966 (Other Identifier: UFIRST)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No