TEND Study:Telemedicine Nurse DBS for Parkinson's Disease
Status
Withdrawn
Conditions
Parkinson Disease
Treatments
Other: Nurse Telehealth
Other: STANDARD DBS
Study type
Interventional
Funder types
Other
Identifiers
Details and patient eligibility
About
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.
Sex
All
Ages
18 to 100 years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Supportive Care
Allocation
Randomized
Interventional model
Single Group Assignment
Masking
None (Open label)
0 participants in 2 patient groups
Nurse Telehealth Intervention
Experimental group
Description:
Allocated to tele-intervention
Treatment:
Other: Nurse Telehealth
Standard Deep Brain Stimulation (DBS)
Active Comparator group
Description:
Allocated to conventional approach
Treatment:
Other: STANDARD DBS
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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