TEND Study:Telemedicine Nurse DBS for Parkinson's Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Nurse Telehealth
* Other: STANDARD DBS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home Health