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Parkinson DiseaseNCT06252376

Effects of Blood Pressure on Cognition and Cerebral Hemodynamics in PD

A study testing Head-up tilt table in people with Parkinson Disease and Orthostatic Hypertension, run by University of California, San Diego.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The goal of clinical trial is to learn about how blood pressure fluctuations affect cognitive performance (thinking abilities) and brain blood flow in persons with Parkinson's disease with and without orthostatic hypotension (low blood pressure when standing). Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Head-up tilt table
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
15 Aug 2025to 31 Aug 2029
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of idiopathic Parkinson's disease (PD) using the Movement Disorders Society (MDS) Clinical Diagnostic Criteria (Postuma, 2015)
  • Age least 50 years old
  • Hoehn \& Yahr (H\&Y) stages I to III (early to moderate stage PD)
  • Proficiency in the English language (native English speaker level)

Who cannot join

  • Any involuntary movements (i.e., tremor or dyskinesia) greater than 3 cm in amplitude, since the motion artifact can interfere with BP monitor cuff
  • Taking antihypertensive medications or alpha-adrenergic blocking medications since these can cause hypotension.
  • Dementia (including PD dementia (Emre, 2007) characterized by either Dementia Rating Scale 2 (DRS-2) score) 124 or less or clinical evidence of impaired instrumental activities of daily living
  • History of deep brain stimulation (DBS) surgery
  • Any unstable, active medical problem, e.g., decompensated heart failure, liver failure, etc.
  • Moderate or severe carotid artery stenosis (according to North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria (Ferguson, 1999)
Show all 13Show fewer
  • History of cerebral infarction or hemorrhage
  • Uncontrolled diabetes or any other systemic disease that causes autonomic failure
  • Any terminal illness with life expectancy less than 2 years
  • Illiteracy
  • Impairment of hearing or vision that is not corrected by devices (e.g., hearing aids or glasses)
  • Currently pregnant (will be confirmed with a urine pregnancy screening test in people of child-bearing potential)
  • Any other condition, which, in the opinion of the investigator, could place the participant at increased risk (e.g., substance abuse)

About this study

Official title: Effects of Blood Pressure on Cognition and Cerebral Hemodynamics in Parkinson's Disease

The goal of clinical trial is to learn about how blood pressure fluctuations affect cognitive performance (thinking abilities) and brain blood flow in persons with Parkinson's disease with and without orthostatic hypotension (low blood pressure when standing). The main questions it aims to answer are:

  • Is there a certain level of blood pressure that correlates with change in cognitive performance while upright?
  • Is there a certain level of change in brain blood flow that correlates with change in cognitive performance when upright?
  • How does cognitive performance differ between persons with Parkinson's disease that have orthostatic hypotension and those without orthostatic hypotension?
  • How does cognitive performance differ between the supine (laying down) and upright positions?
  • How do blood pressure and brain blood predict changes in cognitive performance over two years?
Read more

Participants in this study will undergo the following procedures:

  • Complete a screening visit with questionnaires, medical history, physical exam, and head-up tilt-table test.
  • Attend one baseline study visit, during which they will undergo a battery of computerized cognitive tests repeated twice: once while laying down and once while upright on a tilt table. Simultaneously, during the experiments we will measure blood pressure using a wrist-worn device and inflatable arm cuff and will measure brain blood flow using functional near-infrared spectroscopy (fNIRS), a non-invasive device that uses light sensors to detect changes in brain blood flow.
  • Attend one two-year follow-up visit, during which they will repeat a battery of computerized cognitive tests repeated twice: once while laying down and once while upright on a tilt table. During this visit, like before, we will measure blood pressure using a wrist-worn device and inflatable arm cuff and will measure brain blood flow using functional near-infrared spectroscopy (fNIRS).

Researchers will compare participants with Parkinson's disease with and without orthostatic hypotension in the laying down and upright positions to see if there are changes in thinking abilities between these groups.

Read the detailed description

Parkinson's disease (PD) is the second most common neurodegenerative disease worldwide and causes disabling non-motor symptoms that include cognitive impairment and low blood pressure (BP) on standing, called orthostatic hypotension (OH). About 30-50% of people with PD have OH; cognitive impairment is also common in PD and has several causes. OH is associated with cognitive impairment in PD, but it is unknown to what extent OH could be a treatable risk factor for cognitive decline. People with PD and OH can experience sudden temporary cognitive dysfunction when upright, suggesting that OH-related drops in BP can transiently reduce blood flow to the brain. In PD, OH also correlates strongly with long-term cognitive decline, predicting a 7-times higher risk of dementia. But it is unclear to what extent episodic cerebral hypoperfusion from OH - even if asymptomatic - contributes to ischemic brain damage that impacts long-term cognitive impairment in PD, which is a critical knowledge gap.

This project's objective is to determine how BP affects positional cognitive performance and brain blood flow in PD. We hypothesize that in person with PD patients with OH, but not those without OH, a critical threshold of cerebral hypoperfusion correlates with acute, temporary cognitive deficits when upright compared to supine and contributes to chronic cognitive decline.

The proposed experiments will close the existing knowledge gaps by determining the associations between BP and cerebral hemodynamics (brain blood flow) with cognitive performance. Experiments will be performed at baseline and repeated at two years. Sixty non-demented individuals with PD with OH (n=30) and without OH (n=30) will complete a computerized battery of cognitive tests in the supine and upright positions on a tilt table while undergoing simultaneous, non-invasive, continuous monitoring of BP and brain hemodynamics using functional near-infrared spectroscopy (fNIRS). Aim 1 will determine how BP relates to cognitive performance while supine and while upright. Aim 2 will use fNIRS to determine how cerebral hemodynamics (fNIRS) relate to cognitive performance and BP. Aim 3 will repeat the baseline assessments at a two-year follow-up visit to determine which BP and fNIRS measures are most associated with cognitive decline. We will compare these outcomes in participants with and without OH. This study will yield novel data about the short-term and long-term effects of low BP on cognitive performance and brain hemodynamics. Improving understanding of how BP affects cognition in PD will advance knowledge toward developing treatment targets to reverse, prevent, or delay OH-related cognitive impairment.

Being tested
Head-up tilt table
Keywords
Parkinson's disease, Blood pressure, Blood flow, Cognition, fNIRS
Medical subject headings
Parkinson Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Head-up tilt tableDiagnostic test

    Different versions of cognitive assessments will be administered in the supine and upright positions while the participant is on the tilt table.

Study groups in NCT06252376
Study groupRoleWhat they receive
Supine cognitive testing firstExperimentalParticipants will undergo a computerized cognitive battery in the supine position, followed by a similar battery with alternate test versions in the upright position while on a head-up tilt table.
Receives: Diagnostic Test: Head-up tilt table
Upright cognitive testing firstExperimentalParticipants will undergo a computerized cognitive battery in the upright position, followed by a similar battery with alternate test versions in the supine position while on a head-up tilt table.
Receives: Diagnostic Test: Head-up tilt table

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Verbal fluency score (number of words generated in one minute)

    Participant names as many words from a prompt as possible in one minute. Minimum: 0; Maximum: N/A; higher is better

    Measured: 24 months

  2. Blood pressure (mmHg)

    Participants' blood pressure will be measured during the visit.

    Measured: 24 months

  3. Oxygenated hemoblobin change from baseline

    Functional near-infrared spectroscopy will measure relative changes in oxygenated hemoglobin during cognitive testing.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2024
  2. Study start15 Aug 2025 (estimated)
  3. Primary completion1 Jun 2029 (estimated)
  4. Study completion31 Aug 2029 (estimated)

Why it stopped: Never started; study did not receive funding

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06252376
Sponsor's protocol ID
210738a
Status last verified
Apr 2026
First submitted
1 Feb 2024
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Longardner K, Bayram E, Litvan I. Orthostatic Hypotension Is Associated With Cognitive Decline in Parkinson Disease. Front Neurol. 2020 Sep 2;11:897. doi: 10.3389/fneur.2020.00897. eCollection 2020.

    PubMed 32982926
  • Freeman R, Illigens BMW, Lapusca R, Campagnolo M, Abuzinadah AR, Bonyhay I, Sinn DI, Miglis M, White J, Gibbons CH. Symptom Recognition Is Impaired in Patients With Orthostatic Hypotension. Hypertension. 2020 May;75(5):1325-1332. doi: 10.1161/HYPERTENSIONAHA.119.13619. Epub 2020 Mar 30.

    PubMed 32223377
  • Gibbons CH, Schmidt P, Biaggioni I, Frazier-Mills C, Freeman R, Isaacson S, Karabin B, Kuritzky L, Lew M, Low P, Mehdirad A, Raj SR, Vernino S, Kaufmann H. The recommendations of a consensus panel for the screening, diagnosis, and treatment of neurogenic orthostatic hypotension and associated supine hypertension. J Neurol. 2017 Aug;264(8):1567-1582. doi: 10.1007/s00415-016-8375-x. Epub 2017 Jan 3.

    PubMed 28050656
  • Udow SJ, Robertson AD, MacIntosh BJ, Espay AJ, Rowe JB, Lang AE, Masellis M. 'Under pressure': is there a link between orthostatic hypotension and cognitive impairment in alpha-synucleinopathies? J Neurol Neurosurg Psychiatry. 2016 Dec;87(12):1311-1321. doi: 10.1136/jnnp-2016-314123. Epub 2016 Sep 9.

    PubMed 27613160
  • McDonald C, Newton JL, Burn DJ. Orthostatic hypotension and cognitive impairment in Parkinson's disease: Causation or association? Mov Disord. 2016 Jul;31(7):937-46. doi: 10.1002/mds.26632. Epub 2016 Apr 19.

    PubMed 27091624
  • Poda R, Guaraldi P, Solieri L, Calandra-Buonaura G, Marano G, Gallassi R, Cortelli P. Standing worsens cognitive functions in patients with neurogenic orthostatic hypotension. Neurol Sci. 2012 Apr;33(2):469-73. doi: 10.1007/s10072-011-0746-6. Epub 2011 Sep 6.

    PubMed 21894556
  • Centi J, Freeman R, Gibbons CH, Neargarder S, Canova AO, Cronin-Golomb A. Effects of orthostatic hypotension on cognition in Parkinson disease. Neurology. 2017 Jan 3;88(1):17-24. doi: 10.1212/WNL.0000000000003452. Epub 2016 Nov 30.

    PubMed 27903817
  • Pinti P, Tachtsidis I, Hamilton A, Hirsch J, Aichelburg C, Gilbert S, Burgess PW. The present and future use of functional near-infrared spectroscopy (fNIRS) for cognitive neuroscience. Ann N Y Acad Sci. 2020 Mar;1464(1):5-29. doi: 10.1111/nyas.13948. Epub 2018 Aug 7.

    PubMed 30085354
  • Palma JA, Gomez-Esteban JC, Norcliffe-Kaufmann L, Martinez J, Tijero B, Berganzo K, Kaufmann H. Orthostatic hypotension in Parkinson disease: how much you fall or how low you go? Mov Disord. 2015 Apr 15;30(5):639-45. doi: 10.1002/mds.26079. Epub 2015 Feb 12.

    PubMed 25678194
  • Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.

    PubMed 26474316
  • Kaufmann H, Malamut R, Norcliffe-Kaufmann L, Rosa K, Freeman R. The Orthostatic Hypotension Questionnaire (OHQ): validation of a novel symptom assessment scale. Clin Auton Res. 2012 Apr;22(2):79-90. doi: 10.1007/s10286-011-0146-2. Epub 2011 Nov 2.

    PubMed 22045363
  • Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.

    PubMed 19025984

Questions about this trial

What is this clinical trial studying?

A study testing Head-up tilt table in people with Parkinson Disease and Orthostatic Hypertension, run by University of California, San Diego.

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 4 inclusion and 13 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 27 Apr 2026. 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?

Verbal fluency score (number of words generated in one minute) (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06252376, which also lists 12 linked publications.

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 27 Apr 2026.

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