AzTrials
AzTrials

Parkinson DiseaseNCT06293118

The Effects of Ischemic Conditioning in Individuals With Parkinson's Disease

A study testing Ischemic conditioning group in people with Parkinson Disease, run by Hospital Israelita Albert Einstein.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Ischemic conditioning (IC) is a promising therapy that can mimic the physiological effects of physical exercise. IC consists of using a cuff to measure blood pressure and calibrate 200 mmHg on the upper or lower limb. Read more about this study

Who is it for?
Ages 40 to 90 years
Conditions the study is for
Parkinson Disease
What is being tested?
Ischemic conditioning group
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
No sites listed yet
Study dates
15 Dec 2026to 1 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • PD patients aged 40 years or older;
  • Diagnosis of PD without cognitive complaints or with complaints, but without impact on daily activities;

Who cannot join

  • Patients with uncontrolled diabetes mellitus or peripheral neuropathy;
  • Uncontrolled arterial hypertension (BP>160/100mmHg);
  • Uncontrolled diabetes (Fasting glucose > 250mg/dl, peripheral retinopathy or diabetic ketoacidosis);
  • Uncontrolled dyslipidemia (total chol > 220mg/dL);
  • Pre-existing autoimmune diseases;
  • Infectious conditions for less than 1 month;
Show all 12Show fewer
  • Neurological problems that prevent training from being carried out;
  • History of anemia, cerebral vascular disease, myocardial infarction in the last 6 months;
  • Previous deep vein thrombosis;
  • Smoking < 6 months;
  • Symptomatic peripheral arterial obstructive disease;
  • Cognitive dysfunction: Moca < 24.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

SAMUEL AMORIM DE SOUZA, Master contact

11983331912

samuel.amorim.s@gmail.com

Kenneth J Gollob, PhD contact

31 996719224

kjgollob.einstein@gmail.com

About this study

Official title: The Chronic Effect of Ischemic Conditioning on Cognitive Performance, Motor Function and Immune System in Individuals With Parkinson's Disease

Ischemic conditioning (IC) is a promising therapy that can mimic the physiological effects of physical exercise. IC consists of using a cuff to measure blood pressure and calibrate 200 mmHg on the upper or lower limb. Thus, at alternating intervals of 5 minutes, ischemia or reperfusion occurs, depending on whether the cuff is inflated or deflated. IC induces changes in spinal cord excitability for the last reflex reactions of recruited motoneurons with improved balance control in healthy young people and improved learning in the elderly. The objective of the present study is to evaluate the chronic effect of IC on the cognitive performance of patients with Parkinson's disease. Furthermore, the investigators will evaluate secondary outcomes such as the motor function, mobility, quality of life, and immunological responses.

Read the detailed description

Parkinson's disease (PD) is a neurodegenerative disorder that causes a variety of motor and non-motor symptoms. Typically, patients with PD suffer from disabilities and secondary complications even when the disease is optimally treated, and many patients still have sedentary lifestyles, which in turn result in higher rates of mortality and comorbidity. Physical activity is an essential element in maintaining daily functional capabilities and quality of life. However, patients with PD have motor and non-motor deficits that can prevent or limit physical exercise, such as running or resistance exercise. Ischemic conditioning (IC) is a promising therapy that can mimic the physiological effects of physical exercise. IC consists of using a cuff to measure blood pressure, calibrated between 180 and 200 mmHg on the upper or lower limb. Thus, at alternating intervals of 5 minutes, ischemia or reperfusion occurs, depending on whether the cuff is inflated or deflated. IC induces changes in spinal cord excitability for the last reflex reactions of recruited motoneurons with improved balance control in healthy young people and improved learning in the elderly. Recently, IC has been shown to improve cognitive performance in neurological patients with stroke, subcortical ischemia, and vascular dementia. However, there are no studies that have evaluated the effect of IC on cognitive performance in patients with PD. The objective of the present study is to evaluate the chronic effect of IC on the cognitive performance of patients with PD. Furthermore, the investigators intend to evaluate other secondary outcomes such as motor function, mobility, quality of life, and immunological responses.

Being tested
Ischemic conditioning group, Sham group
Keywords
ischemic conditioning, immune system, motor function, cognitive performance, Parkinson disease
Medical subject headings
Parkinson Disease

What participants receive

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

  • Ischemic conditioning groupDevice

    The ischemic conditioning protocol will consist of a period of 12 weeks (24 sessions) with a frequency of 2 weekly sessions lasting between 15 and 20 minutes each. Therapy will be performed bilaterally on the upper limbs. The ischemic conditioning group will perform 4 times, 8 cycles with 30 seconds of ischemia (80 - 200 mmHg) with 5 seconds of reperfusion in each cycle. Ischemia cycles are controlled by a device (KAATSU C4 - KAATSU GLOBAL / USA) with customized ischemia programs, partially restricting blood flow through special pressure cuffs that are internally valved, providing greater comfort and safety for these patients who typically have stiffness in the affected limb and localized muscle pain. In the first cycle, participants will be subjected to pressures of 80 to 150 mmHg. In the 3 subsequent cycles, pressures from 130 to 200 mmHg will be applied.

  • Sham groupDevice

    In the sham group, participants will complete the same number of sets (4) and 4 cycles, with equalized time to ischemia (4 minutes) and (40 seconds) reperfusion timing, but at a non-occlusive pressure of 30 mmHg. Device, cuff placement, instructions, staff contact, and session duration will be standardized across groups.

Study groups in NCT06293118
Study groupRoleWhat they receive
Ischemic conditioning groupExperimentalTherapy will be performed bilaterally on the upper limbs. The ischemic conditioning group will perform 4 times, 8 cycles with 30 seconds of ischemia (80 - 200 mmHg) with 5 seconds of reperfusion in each cycle. Ischemia cycles are controlled by a device (KAATSU C4 - KAATSU GLOBAL / USA) In the first cycle, participants will be subjected to pressures of 80 to 150 mmHg. In the 3 subsequent cycles, pressures from 130 to 200 mmHg will be applied.
Receives: Device: Ischemic conditioning group
Sham groupSham comparatorParticipants in the control group (Sham) will perform the same number of sets and 4 cycles, with equalized time to ischemia (4 minutes) and (40 seconds) reperfusion timing, but at a non-occlusive pressure of 30 mmHg (KAATSU C4 device)
Receives: Device: Sham group

What is being measured

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

  1. Montreal cognitive assesment

    Maximum score: 30 points; Normal cognition: 26-30 points; Mild cognitive impairment (MCI): Below 26 points

    Measured: Before intervention and at week 12

Secondary outcomes (6)
  1. The Parkinson's Disease Questionnaire-39

    The overall score ranges from 0 to 100%, with higher scores indicating a greater negative impact of Parkinson's Disease on the patient's quality of life.

    Measured: Before intervention and at week 12

  2. Unified Parkinson's Disease Rating Scale

    0-260 points: A higher score indicates greater impairment

    Measured: Time Frame: Before intervention and at week 12

  3. Timed up and go

    <10 seconds: Individuals are generally able to perform most daily activities independently without assistance; 10-19 seconds: Indicates independence in most daily activities but may suggest slight mobility limitations; 20-29 seconds: Suggests the need for assistance with mobility, especially for more challenging tasks;

    ≥30 seconds: Indicates a high fall risk, and the individual likely needs assistance with many daily tasks and may require mobility aids.

    Measured: Before intervention and at week 12

  4. Assessment of cellular and soluble immune response

    The patient's peripheral blood will be collected in three EDTA tubes of 5 mL each before and after 12 weeks of application of the ischemic conditioning protocol. From the blood samples, plasma will be obtained for quantification of soluble mediators, followed by the isolation/storage of peripheral blood mononuclear cells (PBMC or Peripheral Blood Mononuclear Cell) for phenotypic characterization of subpopulations of T and B lymphocytes, NK cells, myeloids and monocytes

    Measured: Before intervention and at week 12

  5. Quantifications of systemic soluble mediators

    Initially, the EDTA tubes containing the blood will be centrifuged for 5 minutes at 400 x g and 20 ºC to separate the plasma. The collected plasma will be aliquoted into cryotubes and stored at -80ºC until the tests are carried out. Quantification of systemic soluble mediators will be performed using the MILLIPLEX® Human Cytokine/Chemokine/Growth Factor Panel A Kit H - Immunology Multiplex Assay (Merck Millipore, Massachusetts, USA). The panel of analytes included chemokines, growth factors, pro-inflammatory cytokines and regulatory cytokines: FGF-2/FGF-basic, G-CSF, GM-CSF, IFNa2,IFNy, IL-1a, IL-1b, IL-1RA , IL-2, IL-4, IL-6, IL-7, IL-8/CXCL8, IL-10, IL-12 (p40), IL-12 (p70), IL-13, IL-15, IL -17A/CTLA8, IL-18, IP-10/CXCL10, MCP-1/CCL2, MCP-3/CCL7, M-CSF, MIG/CXCL9, MIP-1a/CCL3, MIP-1b/CCL4, PDGF-AB /BB, RANTES/CCL5, TNFa, TNFb/Lymphotoxin-a, VEGF-A, HIF-1ą. The PCR, BNDF, and Irisin proteins will be measured using single-plex assays.

    Measured: Before intervention and at week 12

  6. PBMC acquisition and flow cytometry

    Finally, a minimum of 100,000 events will be acquired on the BD LSRFortessa™ flow cytometer (BD Biosciences).

    Measured: Before intervention and at week 12

Timeline

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

  1. First posted5 Mar 2024
  2. Study start15 Dec 2026 (estimated)
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Dec 2028 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1. Ischemic conditioning group 2. control group (Sham)
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06293118
Sponsor's protocol ID
71055423.3.0000.0071
Status last verified
Oct 2026
First submitted
19 Feb 2024
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Poewe et al. Parkinson disease. Nat Rev 2017;3:1-21. doi:10.1038/nrdp.2017.13

  • Dickson DW, Braak H, Duda JE, Duyckaerts C, Gasser T, Halliday GM, Hardy J, Leverenz JB, Del Tredici K, Wszolek ZK, Litvan I. Neuropathological assessment of Parkinson's disease: refining the diagnostic criteria. Lancet Neurol. 2009 Dec;8(12):1150-7. doi: 10.1016/S1474-4422(09)70238-8.

    PubMed 19909913
  • Kaushik S, Cuervo AM. Proteostasis and aging. Nat Med. 2015 Dec;21(12):1406-15. doi: 10.1038/nm.4001.

    PubMed 26646497
  • Bose A, Beal MF. Mitochondrial dysfunction in Parkinson's disease. J Neurochem. 2016 Oct;139 Suppl 1:216-231. doi: 10.1111/jnc.13731. Epub 2016 Aug 21.

    PubMed 27546335
  • Poewe W. Clinical measures of progression in Parkinson's disease. Mov Disord. 2009;24 Suppl 2:S671-6. doi: 10.1002/mds.22600.

    PubMed 19877235
  • Post B, Merkus MP, de Bie RM, de Haan RJ, Speelman JD. Unified Parkinson's disease rating scale motor examination: are ratings of nurses, residents in neurology, and movement disorders specialists interchangeable? Mov Disord. 2005 Dec;20(12):1577-84. doi: 10.1002/mds.20640.

    PubMed 16116612
  • Schapira AHV, Chaudhuri KR, Jenner P. Non-motor features of Parkinson disease. Nat Rev Neurosci. 2017 Jul;18(7):435-450. doi: 10.1038/nrn.2017.62. Epub 2017 Jun 8.

    PubMed 28592904
  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PubMed 15817019
  • Xu R, He Q, Wang Y, Yang Y, Guo ZN. Therapeutic Potential of Remote Ischemic Conditioning in Vascular Cognitive Impairment. Front Cell Neurosci. 2021 Aug 3;15:706759. doi: 10.3389/fncel.2021.706759. eCollection 2021.

    PubMed 34413726
  • Loukogeorgakis SP, Williams R, Panagiotidou AT, Kolvekar SK, Donald A, Cole TJ, Yellon DM, Deanfield JE, MacAllister RJ. Transient limb ischemia induces remote preconditioning and remote postconditioning in humans by a K(ATP)-channel dependent mechanism. Circulation. 2007 Sep 18;116(12):1386-95. doi: 10.1161/CIRCULATIONAHA.106.653782. Epub 2007 Aug 27.

    PubMed 17724264
  • Strijdom H, Friedrich SO, Hattingh S, Chamane N, Lochner A. Hypoxia-induced regulation of nitric oxide synthase in cardiac endothelial cells and myocytes and the role of the PI3-K/PKB pathway. Mol Cell Biochem. 2009 Jan;321(1-2):23-35. doi: 10.1007/s11010-008-9906-2. Epub 2008 Sep 14.

    PubMed 18791856
  • Sutter EN, Mattlage AE, Bland MD, Cherry-Allen KM, Harrison E, Surkar SM, Gidday JM, Chen L, Hershey T, Lee JM, Lang CE. Remote Limb Ischemic Conditioning and Motor Learning: Evaluation of Factors Influencing Response in Older Adults. Transl Stroke Res. 2019 Aug;10(4):362-371. doi: 10.1007/s12975-018-0653-8. Epub 2018 Aug 7.

    PubMed 30088217
  • Guo ZN, Guo WT, Liu J, Chang J, Ma H, Zhang P, Zhang FL, Han K, Hu HH, Jin H, Sun X, Simpson DM, Yang Y. Changes in cerebral autoregulation and blood biomarkers after remote ischemic preconditioning. Neurology. 2019 Jul 2;93(1):e8-e19. doi: 10.1212/WNL.0000000000007732. Epub 2019 May 29.

    PubMed 31142636
  • He Z, Xu N, Qi S. Remote ischemic preconditioning improves the cognitive function of elderly patients following colon surgery: A randomized clinical trial. Medicine (Baltimore). 2017 Apr;96(17):e6719. doi: 10.1097/MD.0000000000006719.

    PubMed 28445286
  • Zhou D, Ding J, Ya J, Pan L, Bai C, Guan J, Wang Z, Jin K, Yang Q, Ji X, Meng R. Efficacy of remote ischemic conditioning on improving WMHs and cognition in very elderly patients with intracranial atherosclerotic stenosis. Aging (Albany NY). 2019 Jan 28;11(2):634-648. doi: 10.18632/aging.101764.

    PubMed 30689549

Questions about this trial

What is this clinical trial studying?

A study testing Ischemic conditioning group in people with Parkinson Disease, run by Hospital Israelita Albert Einstein.

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 12 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: opening soon, as of the sponsor's last update on 6 Nov 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact SAMUEL AMORIM DE SOUZA, Master (11983331912, samuel.amorim.s@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montreal cognitive assesment (time frame: Before intervention and at week 12). 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 NCT06293118, which also lists 17 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 6 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in