Trials Sponsors Conditions Drugs Pricing

Conditions

Parkinson Disease

Keywords

Home Health

Outcome Measures

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.
6 MONTHS from date of enrollment

Secondary Outcomes (1)

PDQ-39 Scores
6-months

Other Outcomes (1)

UPDRS scores
6-months

Study Arms (2)

Nurse Telehealth Intervention

EXPERIMENTAL

Allocated to tele-intervention

Other: Nurse Telehealth

Standard Deep Brain Stimulation (DBS)

ACTIVE COMPARATOR

Allocated to conventional approach

Other: STANDARD DBS

Interventions

Nurse TelehealthOther

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

Nurse Telehealth Intervention

STANDARD DBSOther

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

Standard Deep Brain Stimulation (DBS)

Eligibility Criteria

Age18 Years - 100 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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.

Sponsors & Collaborators

University of Florida
Otherlead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

Michael Okun, MD
University of Florida
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 21, 2020

Study Start

January 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Stopped

TEND Study:Telemedicine Nurse DBS for Parkinson's Disease

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

Nurse Telehealth Intervention

Standard Deep Brain Stimulation (DBS)

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

Nurse Telehealth Intervention

Standard Deep Brain Stimulation (DBS)

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record