Clinical trial NCT04510922: Lundbeck TOMs Orthostatic Hypotension
Official title: Technology-Based Objective Measures for Gait and Postural Assessment in Parkinson Disease Patients With Orthostatic Hypotension: Feasibility and Effect-Size Finding Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Orthostatic Hypotension
Idiopathic Parkinson Disease
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Lundbeck LLC
First posted: 2020-08-12
Enrollment: 9
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Orthostatic hypotension (OH), which consists in a significant reduction in blood pressure levels upon standing from a seated position, may affect approximately one in three patients with Parkinson's disease (PD). It usually presents as dizziness, lightheadedness, feeling faint, or feeling like you might black out while standing. This can significantly impact the quality of life (QoL) of PD patients, resulting in difficulties with balance, walking, and increased risk of falls. The main aim of this study is to evaluate whether the use of technological devices (a computerized system for analyzing abnormalities in walking in clinical settings and a wearable sensor to detect changes in postural unsteadiness in the home environment) may improve the detection of complications and the response to medical therapies for OH in patients with PD.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's Disease, meeting UK Brain Bank criteria for at least 3 years
* Hoehn and Yahr (H\&Y) stage I-III
* Age between 30 and 80 years old (both inclusive)
* Stable dosage of dopaminergic medications for at least 4 weeks
* Orthostatic Hypotension, defined as a fall in systolic BP ≥ 20 mmHg or diastolic BP ≥ 10 mmHg within 3 minutes of standing
* Willingness and ability to comply with scheduled visits

Exclusion Criteria:

* Diabetes mellitus or other diseases potentially associated with autonomic dysfunction
* Treatment with antihypertensive drugs or with alpha-adrenergic antagonists
* Cognitive impairment, defined as a score \< 24 at the Montreal Cognitive Assessment (MoCA)
* Any atypical signs lowering the diagnostic certainty for PD
* Lack of postural reflex defined as a score \> 2 at the MDS-UPDRS item 3.12 (recover at the pull test)
* Severe levodopa induced dyskinesia, defined as an MDS-UPDRS item 4.2 \> 2 (functional impact of dyskinesia)

Primary outcomes:
measure: Orthostatic Hypotension Questionnaire (OHQ) Score
timeFrame: 1 month
measure: Tinetti Score
timeFrame: 6 weeks
measure: PDQ-39 Score
timeFrame: 6 weeks
measure: Gait Analysis - Stride Length
timeFrame: 1 month
measure: Gait Analysis - Single Leg Stance Time
timeFrame: 6 weeks
measure: Gait Analysis - Gait Velocity
timeFrame: 6 weeks
measure: Postural Analysis - Postural Sway
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
References:
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