Back to resultsTEND Study:Telemedicine Nurse DBS for Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nurse Telehealth
STANDARD DBS
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson Disease focused on measuring Home Health
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nurse Telehealth Intervention
Standard Deep Brain Stimulation (DBS)
Arm Description
Allocated to tele-intervention
Allocated to conventional approach
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04677621
Brief Title
TEND Study:Telemedicine Nurse DBS for Parkinson's Disease
Official Title
Telemedicine Nurse DBS for Parkinson's Disease: The TEND Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Funding never received closed with the IRB
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Home Health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nurse Telehealth Intervention
Arm Type
Experimental
Arm Description
Allocated to tele-intervention
Arm Title
Standard Deep Brain Stimulation (DBS)
Arm Type
Active Comparator
Arm Description
Allocated to conventional approach
Intervention Type
Other
Intervention Name(s)
Nurse Telehealth
Intervention Description
Subjects will receive nurse telehealth Mobile Decision Support System (MAP) DBS care
Intervention Type
Other
Intervention Name(s)
STANDARD DBS
Intervention Description
Subjects will receive standard in-person clinic-based DBS care administered without the use of Mobile Decision Support System (MAP) DBS
Primary Outcome Measure Information:
Title
The number of participant clinic visits
Description
The number of in-person clinic visits required for each participant during the 6-month post operative DBS period.
Time Frame
6 MONTHS from date of enrollment
Secondary Outcome Measure Information:
Title
PDQ-39 Scores
Description
Difference in PDQ-39 scores from baseline to the 6-month time point. PDQ summary index score 0-very good to 100 bad
Time Frame
6-months
Other Pre-specified Outcome Measures:
Title
UPDRS scores
Description
Difference in UPDRS scores from baseline to 6-month time point. UPDRS scoring scale 0-very good to 100-bad
Time Frame
6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Okun, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TEND Study:Telemedicine Nurse DBS for Parkinson's Disease
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