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WithdrawnNCT04677621Updated Jun 8, 2023

TEND Study:Telemedicine Nurse DBS for Parkinson's Disease

An interventional study of Nurse Telehealth and STANDARD DBS in Parkinson Disease, sponsored by University of Florida. Withdrawn. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-06-08.

Sponsored by University of Florida · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
Funding never received closed with the IRB
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
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Study 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.

02

Conditions studied

  • Parkinson Disease

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Keywords

  • Home Health
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

Browse Parkinson Disease studies →

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Nurse Telehealth Intervention

    Allocated to tele-intervention

    Other: Nurse Telehealth

  • Active comparator
    Standard Deep Brain Stimulation (DBS)

    Allocated to conventional approach

    Other: STANDARD DBS

Interventions

  • OtherNurse Telehealth

    Subjects will receive nurse telehealth Mobile Decision Support System (MAP) DBS care

  • OtherSTANDARD DBS

    Subjects will receive standard in-person clinic-based DBS care administered without the use of Mobile Decision Support System (MAP) DBS

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 MONTHS from date of enrollment

Secondary outcomes

  1. 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

    Time frame: 6-months

Other outcomes

  1. UPDRS scores

    Difference in UPDRS scores from baseline to 6-month time point. UPDRS scoring scale 0-very good to 100-bad

    Time frame: 6-months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04677621
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Dec 21, 2020
Start date
Jan 2023 (estimated)
Primary completion
May 15, 2023
Completion
May 15, 2023
Last update
Jun 8, 2023

Study contacts

Michael Okun, MD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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