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Tilt Table Therapy for Parkinson's Disease with Orthostatic Hypotension

N/A

Recruiting

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of idiopathic Parkinson Disease using the Movement Disorders Society (MDS) Clinical Diagnostic Criteria

Age at least 50 years old

Must not have

Dementia (including PD dementia)

Taking antihypertensive medications or alpha-adrenergic blocking medications, since these can cause hypotension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how low blood pressure (BP) affects brain function in people with Parkinson's disease (PD), who often experience problems thinking and orthostatic hypotension (OH), i.e., low BP when standing.

Who is the study for?

This trial is for people over 50 with Parkinson's Disease (PD) who can walk without help and speak English fluently. They should be in the early to moderate stages of PD but not have unstable medical conditions, uncontrolled diabetes, recent fainting episodes, severe involuntary movements, significant carotid artery narrowing, hearing or vision impairments not corrected by devices, pregnancy, dementia including PD dementia, a history of stroke or brain surgery.

What is being tested?

The study tests how blood pressure affects thinking and brain blood flow in PD patients when they change positions from lying down to standing up. It uses wearable technology to monitor these changes continuously during cognitive tests performed both while supine and upright.

What are the potential side effects?

There are no direct side effects from the interventions being studied since it involves non-invasive monitoring using a tilt table test. However, participants may experience their usual symptoms related to orthostatic hypotension such as lightheadedness or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Parkinson's Disease.

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I am at least 50 years old.

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My Parkinson's is early to moderate; I can walk without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with dementia.

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I am taking medication for high blood pressure or medications that affect my blood pressure.

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I have fainted in the last week.

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I have diabetes or another disease that is not under control.

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I do not have any current severe or uncontrolled health issues.

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I have had deep brain stimulation surgery.

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I have had a stroke or brain bleed in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Delis-Kaplan Executive Function System Verbal Fluency Test score (number of words per minute). Minimum: 0; Maximum: N/A; higher is better

Oxygenated and deoxygenated hemoglobin change from baseline

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Upright cognitive testing firstExperimental Treatment1 Intervention

The cognitive testing sessions will be alternated between supine and upright positions. This group will perform cognitive testing sessions in the following order: 1) upright, 2) supine, 3) upright, 4) supine.

Group II: Supine cognitive testing firstExperimental Treatment1 Intervention

The cognitive testing sessions will be alternated between supine and upright positions. This group will perform cognitive testing sessions in the following order: 1) supine, 2) upright, 3) supine, 4) upright.

0 / 10Eligibility criteria met