To Evaluate the Dose-response Effects of a Defined Volume of Physical Exercise on the Change of Peripheral Biomarkers, Clinical Response and Brain Connectivity in Parkinson's Disease: a Prospective, Observational, Cohort Pilot Study (METEX-PD)

February 11, 2025 updated by: Casa di Cura San Raffaele Cassino

Dose-response Effects of Physical Exercise Standardized Volume on Peripheral Biomarkers, Clinical Response and Brain Connectivity in Parkinson's Disease: a Prospective, Observational, Cohort Pilot Study

This is a prospective, observational, cohort pilot study of standardize volume of aerobic exercise on changes in BDNF concentration at 4-weeks of exercise training among Parkinson disease patients.

Thirty (N=30) participants will be consecutively enrolled and assigned to 2 groups: 1) Extensive Rehabilitation Group (exercise volume: 180 METs-min/week) or 2) Intensive Rehabilitation Group (exercise volume: 1350 METs-min/week).

The primary objective is to evaluate the dose-response effects of two different rehabilitation settings, characterized by different workload (measured as energy expenditure), on blood BDNF levels.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This pilot observational study will evaluate the dose-response relationship between the volume of exercise, measured as METs-minutes/week, of two different rehabilitation settings to quantify the change in BDNF concentration in PD patients.

The study will also compare the changes induced by extensive and intensive rehabilitation settings in other neurotrophic factors and peripheral biomarkers, on motor and non-motor symptoms, kinematic parameters of gait, cognitive function, quality of life and the changes in cortical activity assessed with electroencephalogram (EEG) and in brain connectivity by functional magnetic resonance imaging (fMRI).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Parkinson's Disease

Description

Inclusion Criteria:

  • Diagnosis of Parkinson's Disease according to the United Kingdom (UK) Parkinson's Disease Society Brain Bank
  • Aged between 30 and 80 years
  • Disease stage II-III in "ON" phase according to modified Hoehn and Yahr (H&Y)

  • Having no severe cognitive impairment:

    • Mini-Mental State Examination-MMSE ≥24
    • Montreal Cognitive Assessment - MoCA ≥ 17/30
  • Under stable dopaminergic pharmacological treatment
  • Motor condition that permits to execute 6-Minutes Walking Test (6MWT)
  • Willing to participate in the study, understand the procedures and sign the informed consent.

Exclusion Criteria:

  • Diagnosis of neurological disorders not related to Parkinson's disease
  • Musculoskeletal diseases that could impair gait and execution of exercise program
  • Presence of known cardiovascular disease that can compromise the performance required by the protocol
  • Presence of diabetes or other metabolic and endocrine disease
  • Uncontrolled hypertension (resting blood pressure >150/90 mmHg)
  • Individuals with orthostatic hypotension and systolic pressure in feet below 100 will be excluded. Orthostatic hypotension (OH) is a reduction in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg within 3 minutes of standing.
  • Hypo- or hyperthyroidism (TSH <0.5 or >5.0 mU/L), abnormal liver function (AST or ALT more than 2 times the upper limit of normal, ULN), alteration of kidney function.
  • Values of complete blood test out of range and abnormal value clinically significant as per clinical judgment.
  • Recent use of psychotropic drugs (e.g. anxiolytics, hypnotics, benzodiazepines, antidepressants) in which the dosage was not stable for 28 days before screening
  • Severe disease (requiring systemic treatment and/or hospitalization) in the last 4 weeks.
  • Any other clinically significant medical condition, psychiatric condition, drug or alcohol abuse, laboratory evaluation or abnormality that, in the opinion of the investigators, would interfere with the subject's ability to participate in the study.
  • Beck Depression Inventory II (BDI) score > 28, indicating a severe depression that precludes the ability to exercise.
  • (Only for women) State of pregnancy.
  • Other disorders, injuries, diseases or conditions that may interfere with the ability to perform exercises (e.g. history of stroke, breathing problems, traumatic brain injury, orthopaedic injury or neuromuscular disease).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Extensive Rehabilitation Group
PD patients of Extensive Group will perform a 45-minutes daily session of low-intensity aerobic exercise of 2-3 METs (37%-45% VO 2max ; 57-63% HR max) twice a week, for a 4-weeks period. Exercise volume: 180 METs-minutes/week
Behavioral: Aerobic exercise
Standardized volume of aerobic exercise, measured as METs-minutes/week
Intensive Rehabilitation Group
PD patients of Intensive Rehabilitation Group will exercise for 45 minutes daily at high-intensity aerobic training of 6-8.8 METs (46-91% VO2max ; 76-95% HRmax), five days per week, for 4-weeks period. Exercise volume:1350 METs-minutes/week
Behavioral: Aerobic exercise
Standardized volume of aerobic exercise, measured as METs-minutes/week

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)
Time Frame: 4 weeks
Change from baseline (T0) in blood BDNF concentration
4 weeks
Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)
Time Frame: 8 weeks
Change from baseline (T0) in blood BDNF concentration
8 weeks
Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)
Time Frame: 12 weeks
Change from baseline (T0) in blood BDNF concentration
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1)
Time Frame: 4 weeks
Change from baseline (T0) in peripheral blood IGF-1 concentration (μg/L)
4 weeks
Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1)
Time Frame: 8 weeks
Change from baseline (T0) in peripheral blood IGF-1 concentration (μg/L)
8 weeks
Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1)
Time Frame: 12 weeks
Change from baseline (T0) in peripheral blood IGF-1 concentration (μg/L)
12 weeks
Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin
Time Frame: 4 weeks
Change from baseline (T0) in FNDC5/Irisin by peripheral blood samples (ng/mL)
4 weeks
Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin
Time Frame: 8 weeks
Change from baseline (T0) in FNDC5/Irisin by peripheral blood samples (ng/mL)
8 weeks
Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin
Time Frame: 12 weeks
Change from baseline (T0) in FNDC5/Irisin by peripheral blood samples (ng/mL)
12 weeks
Change in peripheral biomarker of inflammation
Time Frame: 4 weeks
Change from baseline (T0) in high sensitivity C-reactive protein (CRP) assessed by peripheral blood samples (mg/L)
4 weeks
Change in peripheral biomarker of inflammation
Time Frame: 8 weeks
Change from baseline (T0) in high sensitivity C-reactive protein (CRP) assessed by peripheral blood samples (mg/L)
8 weeks
Change in peripheral biomarker of inflammation
Time Frame: 12 weeks
Change from baseline (T0) in high sensitivity C-reactive protein (CRP) assessed by peripheral blood samples (mg/L)
12 weeks
Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples
Time Frame: 4 weeks
Change from baseline (T0) in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples
4 weeks
Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples
Time Frame: 8 weeks
Change from baseline (T0) in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples
8 weeks
Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples
Time Frame: 12 weeks
Change from baseline (T0) in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples
12 weeks
Change in blood lactate levels assessed using finger-stick capillary blood samples
Time Frame: 4 weeks
Change from baseline (T0) in blood lactate levels (mM) assessed using finger-stick capillary blood samples
4 weeks
Change in gut microbial diversity (species diversity %) assessed by next-generation sequencing (NGS) of the V3-V4 region of the 16S rDNA gene
Time Frame: 4 weeks
Change from baseline (T0) in blood lactate levels (mM) assessed using finger-stick capillary blood samples
4 weeks
Change in motor symptoms - MDS-UPDRS part II
Time Frame: 4 weeks
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II (motor symptoms of daily living). The minimum score on the MDS-UPDRS Part II is 0 and the maximum is 52 with higher scores representing worse motor symptoms of daily living
4 weeks
Change in motor symptoms - MDS-UPDRS part II
Time Frame: 8 weeks
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II (motor symptoms of daily living). The minimum score on the MDS-UPDRS Part II is 0 and the maximum is 52 with higher scores representing worse motor symptoms of daily living
8 weeks
Change in motor symptoms - MDS-UPDRS part II
Time Frame: 12 weeks
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II (motor symptoms of daily living). The minimum score on the MDS-UPDRS Part II is 0 and the maximum is 52 with higher scores representing worse motor symptoms of daily living
12 weeks
Change in motor symptoms - MDS-UPDRS part III
Time Frame: 4 weeks
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (motor examination). The minimum score on the MDS-UPDRS Part III is 0 and the maximum is 132 with higher scores representing worse motor symptoms
4 weeks
Change in motor symptoms - MDS-UPDRS part III
Time Frame: 8 weeks
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (motor examination). The minimum score on the MDS-UPDRS Part III is 0 and the maximum is 132 with higher scores representing worse motor symptoms
8 weeks
Change in motor symptoms - MDS-UPDRS part III
Time Frame: 12 weeks
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (motor examination). The minimum score on the MDS-UPDRS Part III is 0 and the maximum is 132 with higher scores representing worse motor symptoms
12 weeks
Change in motor symptoms - MDS-UPDRS part IV
Time Frame: 4 weeks
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV (motor complication). The minimum score on the MDS-UPDRS Part IV is 0 and the maximum is 24 with higher scores representing worse motor complication
4 weeks
Change in motor symptoms - MDS-UPDRS part IV
Time Frame: 8 weeks
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV (motor complication). The minimum score on the MDS-UPDRS Part IV is 0 and the maximum is 24 with higher scores representing worse motor complication
8 weeks
Change in motor symptoms - MDS-UPDRS part IV
Time Frame: 12 weeks
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV (motor complication). The minimum score on the MDS-UPDRS Part IV is 0 and the maximum is 24 with higher scores representing worse motor complication
12 weeks
Change in movement analysis - stride length
Time Frame: 4 weeks
Change from baseline (T0) in stride length [m], the distance between two consecutive hell strikes of the same foot evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
4 weeks
Change in movement analysis - stride length
Time Frame: 8 weeks
Change from baseline (T0) in stride length [m], the distance between two consecutive hell strikes of the same foot evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
8 weeks
Change in movement analysis - stride length
Time Frame: 12 weeks
Change from baseline (T0) in stride length [m], the distance between two consecutive hell strikes of the same foot evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
12 weeks
Change in movement analysis - cadence
Time Frame: 4 weeks
Change from baseline (T0) in cadence [steps/min], the number of steps in a minute evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
4 weeks
Change in movement analysis - cadence
Time Frame: 8 weeks
Change from baseline (T0) in cadence [steps/min], the number of steps in a minute evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
8 weeks
Change in movement analysis - cadence
Time Frame: 12 weeks
Change from baseline (T0) in cadence [steps/min], the number of steps in a minute evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
12 weeks
Change in movement analysis - propulsion
Time Frame: 4 weeks
Change from baseline (T0) in propulsion [m/ss], the anterior-posterior acceleration peak during the lower limb swing phase evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
4 weeks
Change in movement analysis - propulsion
Time Frame: 8 weeks
Change from baseline (T0) in propulsion [m/ss], the anterior-posterior acceleration peak during the lower limb swing phase evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
8 weeks
Change in movement analysis - propulsion
Time Frame: 12 weeks
Change from baseline (T0) in propulsion [m/ss], the anterior-posterior acceleration peak during the lower limb swing phase evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
12 weeks
Change in movement analysis - Time Up and Go (TUG)
Time Frame: 4 weeks
Change from baseline (T0) in execution timing of TUG, a reliable and valid test for assessing mobility, balance, walking ability and fall risk, by using a wearable device (G-sensor, BTS Bioengineering, Milan)
4 weeks
Change in movement analysis - Time Up and Go (TUG)
Time Frame: 8 weeks
Change from baseline (T0) in execution timing of Time Up and Go (TUG), a reliable and valid test for assessing mobility, balance, walking ability and fall risk, by using a wearable device (G-sensor, BTS Bioengineering, Milan)
8 weeks
Change in movement analysis - Time Up and Go (TUG)
Time Frame: 12 weeks
Change from baseline (T0) in execution timing of Time Up and Go (TUG), a reliable and valid test for assessing mobility, balance, walking ability and fall risk, by using a wearable device (G-sensor, BTS Bioengineering, Milan)
12 weeks
Change in walking capacity
Time Frame: 4 weeks
Change from baseline (T0) in functional capacity evaluated by 6-minute Walking Test (6MWT), a standardized method to assess the maximal patient's capacity to walk as far as possible (measured in meters)
4 weeks
Change in walking capacity
Time Frame: 8 weeks
Change from baseline (T0) in functional capacity evaluated by 6-minute Walking Test (6MWT), a standardized method to assess the maximal patient's capacity to walk as far as possible (measured in meters)
8 weeks
Change in walking capacity
Time Frame: 12 weeks
Change from baseline (T0) in functional capacity evaluated by 6-minute Walking Test (6MWT), a standardized method to assess the maximal patient's capacity to walk as far as possible (measured in meters)
12 weeks
Change in postural instability
Time Frame: 4 weeks
Change in Berg Balance Scale (BBS), which is a widely used clinical test to assess static and dynamic balance abilities
4 weeks
Change in postural instability
Time Frame: 8 weeks
Change in Berg Balance Scale (BBS), which is a widely used clinical test to assess static and dynamic balance abilities
8 weeks
Change in postural instability
Time Frame: 12 weeks
Change in Berg Balance Scale (BBS), which is a widely used clinical test to assess static and dynamic balance abilities
12 weeks
Change in cognitive function - Montreal Cognitive Assessment (MoCA)
Time Frame: 4 weeks
Change from baseline (T0) in the MoCA. MoCA scores range between 0 and 30, with higher scores representing a better outcome
4 weeks
Change in cognitive function - Montreal Cognitive Assessment (MoCA)
Time Frame: 8 weeks
Change from baseline (T0) in the MoCA. MoCA scores range between 0 and 30, with higher scores representing a better outcome
8 weeks
Change in cognitive function - Montreal Cognitive Assessment (MoCA)
Time Frame: 12 weeks
Change from baseline (T0) in the MoCA. MoCA scores range between 0 and 30, with higher scores representing a better outcome
12 weeks
Change in cognitive function - Mini-Mental Examination (MMSE)
Time Frame: 4 weeks
Change from baseline (T0) in the MMSE. MMSE scores range between 0 and 30, with higher scores representing a better outcome
4 weeks
Change in cognitive function
Time Frame: 8 weeks
Change from baseline (T0) in the MMSE. MMSE scores range between 0 and 30, with higher scores representing a better outcome
8 weeks
Change in cognitive function
Time Frame: 12 weeks
Change from baseline (T0) in the MMSE. MMSE scores range between 0 and 30, with higher scores representing a better outcome
12 weeks
Change in cognitive function - Frontal Assessment Battery (FAB)
Time Frame: 4 weeks
Change from baseline (T0) in the FAB. FAB scores range between 0 and 18, with higher scores representing a better outcome
4 weeks
Change in cognitive function - Frontal Assessment Battery (FAB)
Time Frame: 8 weeks
Change from baseline (T0) in the FAB. FAB scores range between 0 and 18, with higher scores representing a better outcome
8 weeks
Change in cognitive function - Frontal Assessment Battery (FAB)
Time Frame: 12 weeks
Change from baseline (T0) in the FAB. FAB scores range between 0 and 18, with higher scores representing a better outcome
12 weeks
Change in severity of depressive symptomatology
Time Frame: 4 weeks
Change from baseline (T0) in the Beck Depression Inventory-II (BDI-II).
4 weeks
Change in severity of depressive symptomatology
Time Frame: 8 weeks
Change from baseline (T0) in the Beck Depression Inventory-II (BDI-II).
8 weeks
Change in severity of depressive symptomatology
Time Frame: 12 weeks
Change from baseline (T0) in the Beck Depression Inventory-II (BDI-II).
12 weeks
Change in non-motor symptoms
Time Frame: 4 weeks
Change from baseline (T0) in Non-Motor Symptoms Scale (NMSS) in PD
4 weeks
Change in non-motor symptoms
Time Frame: 8 weeks
Change from baseline (T0) in Non-Motor Symptoms Scale (NMSS) in PD
8 weeks
Change in non-motor symptoms
Time Frame: 12 weeks
Change from baseline (T0) in Non-Motor Symptoms Scale (NMSS) in PD
12 weeks
Change in motor fluctuations
Time Frame: 4 weeks
Change from baseline (T0) in wearing OFF episodes will be assessed by Wearing OFF Questionnaire-19 (WOQ-19)
4 weeks
Change in motor fluctuations
Time Frame: 8 weeks
Change from baseline (T0) in wearing OFF episodes will be assessed by Wearing OFF Questionnaire-19 (WOQ-19)
8 weeks
Change in motor fluctuations
Time Frame: 12 weeks
Change from baseline (T0) in wearing OFF episodes will be assessed by Wearing OFF Questionnaire-19 (WOQ-19)
12 weeks
Change in quality of life
Time Frame: 4 weeks
Change from baseline (T0) in will be measured with PDQ-39 questionnaire, which assesses how often PD patients experience difficulties across eight dimensions of daily living (0=never, 4=always).
4 weeks
Change in quality of life
Time Frame: 8 weeks
Change from baseline (T0) in will be measured with PDQ-39 questionnaire, which assesses how often PD patients experience difficulties across eight dimensions of daily living (0=never, 4=always).
8 weeks
Change in quality of life
Time Frame: 12 weeks
Change from baseline (T0) in will be measured with PDQ-39 questionnaire, which assesses how often PD patients experience difficulties across eight dimensions of daily living (0=never, 4=always).
12 weeks
Change in cortical activity
Time Frame: 4 weeks
Change from the baseline (T0) in the cortical activity will be measured with resting-state electroencephalography (rsEEG)
4 weeks
Change in cortical activity
Time Frame: 12 weeks
Change from the baseline (T0) in the cortical activity will be measured with resting-state electroencephalography (rsEEG)
12 weeks
Change in Brain Connectivity
Time Frame: 4 weeks
Change from the baseline (T0) in brain connectivity through functional magnetic resonance imaging (fMRI).
4 weeks
Change in Brain Connectivity
Time Frame: 12 weeks
Change from the baseline (T0) in brain connectivity through functional magnetic resonance imaging (fMRI).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Casa di Cura San Raffaele Cassino

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Rome Tor Vergata
IRCCS San Raffaele Roma
University of Urbino "Carlo Bo"
San Raffaele Telematic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria Francesca De Pandis, MD,PhD, San Raffaele Cassino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 002-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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