Parkinson DiseaseNCT04677621
TEND Study:Telemedicine Nurse DBS for Parkinson's Disease
A study testing Nurse Telehealth and STANDARD DBS in people with Parkinson Disease, run by University of Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Nurse Telehealth and STANDARD DBS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- Nurse Telehealth, STANDARD DBS
- Keywords
- Home Health
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse TelehealthOther
Subjects will receive nurse telehealth Mobile Decision Support System (MAP) DBS care
STANDARD DBSOther
Subjects will receive standard in-person clinic-based DBS care administered without the use of Mobile Decision Support System (MAP) DBS
| Study group | Role | What they receive |
|---|---|---|
| Nurse Telehealth Intervention | Experimental | Allocated to tele-intervention Receives: Other: Nurse Telehealth |
| Standard Deep Brain Stimulation (DBS) | Active comparator | Allocated to conventional approach Receives: Other: STANDARD DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study startJan 2023 (estimated)
- Primary completion15 May 2023
- Study completion15 May 2023
Why it stopped: Funding never received closed with the IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Okun, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677621
- Sponsor's protocol ID
- IRB202002994-N
- Other IDs
- OCR39945, PRO00042966
- Status last verified
- Jun 2023
- First submitted
- 17 Dec 2020
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Nurse DBS for Parkinson's Disease: The TEND Study
- ClinicalTrials.gov ID
- NCT04677621
- Acronym / sponsor ID
- IRB202002994-N
- Conditions
- Parkinson Disease
- Keywords
- Home Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding never received closed with the IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse Telehealth Intervention | Experimental | Other: Nurse TelehealthAllocated to tele-intervention |
| Standard Deep Brain Stimulation (DBS) | Active comparator | Other: STANDARD DBSAllocated to conventional approach |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse TelehealthSubjects will receive nurse telehealth Mobile Decision Support System (MAP) DBS care | Other | Nurse Telehealth Intervention |
| STANDARD DBSSubjects will receive standard in-person clinic-based DBS care administered without the use of Mobile Decision Support System (MAP) DBS | Other | Standard Deep Brain Stimulation (DBS) |
Primary outcome
The number of participant clinic visits
Time frame: 6 MONTHS from date of enrollment
The number of in-person clinic visits required for each participant during the 6-month post operative DBS period.
1 secondary outcome
PDQ-39 Scores
Time frame: 6-months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Okun, MD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Telehealth and STANDARD DBS in people with Parkinson Disease, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participant clinic visits (time frame: 6 MONTHS from date of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.