Deep Brain StimulationApraxia DBSNCT04725773
Apraxia in Parkinson's Disease Patients With Deep Brain Stimulation
An observational study of Deep Brain Stimulation and Parkinson Disease, run by University of Florida at 1 site in United States.
Trial summary
Deep brain stimulation (DBS) of the subthalamic nucleus or globus pallidus internus can improve motor symptoms Parkinson's disease (PD). However, it is not known whether DBS can help reduce the signs and symptoms of the limb-kinetic, ideomotor or ideational apraxia associated with PD or if apraxia can exist as a… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Deep Brain Stimulation, Parkinson Disease, Apraxia, Motor
- What is being tested?
- Deep brain stimulation effect on apraxia
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 28 Jan 2024
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's disease who underwent deep brain stimulation for help of their motor symptoms.
Who may be able to join
- Patients with PD as defined by the UK Brain Bank Criteria
- Male or female, ages 18 to 80 years old
- Chronically implanted DBS of either the STN or GPi for a minimum of 6 months
Who cannot join
- Other neurological diagnoses (e.g. Alzheimer's disease, atypical parkinsonism, stroke)
- History of previous neurosurgical intervention that was not DBS
- Patients with DBS of targets other than the STN or GPi, or leads in both targets
- Patients in whom there is poor manual dexterity for a reason other than PD (e.g. orthopedic injury, amputation)
- Patients with a diagnosis of PD dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health at the University of Florida
Gainesville, Florida, 32608
About this study
Deep brain stimulation (DBS) of the subthalamic nucleus or globus pallidus internus can improve motor symptoms Parkinson's disease (PD). However, it is not known whether DBS can help reduce the signs and symptoms of the limb-kinetic, ideomotor or ideational apraxia associated with PD or if apraxia can exist as a stimulation induced side effect from DBS therapy. In this study, we look to conduct a pilot study to examine the feasibility of characterizing the prevalence of apraxia in PD patients with chronic, stable DBS.
Read the detailed description
This will be a pilot study designed to assess the safety and feasibility of an apraxia testing protocol in chronically implanted PD DBS patients. We hypothesize that apraxia testing in the DBS ON and OFF states will be a safe and well-tolerated testing protocol. We also hypothesize that DBS will affect the severity of limb-kinetic, ideomotor and ideational apraxia in PD patients. This will set the foundation for larger prospective trials to further characterize apraxia in relation to DBS and whether or not DBS programming can modulate this phenomenon.
In this study, we will recruit 60 PD patients with chronic, stable DBS of either the subthalamic nucleus (STN) or globus pallidus interna (GPi). Both unilateral and bilateral DBS patients are eligible for this study. For this study, "chronic, stable DBS" will be defined as patients who have had at least 6 months of optimization programming at the University of Florida. The subjects will be recruited to the Fixel clinic for a 1-day study visit in the medication ON state. The patients will undergo testing for limb-kinetic, ideomotor and ideational apraxia of both upper extremities in the DBS ON state at home therapeutic settings.
- Conditions
- Deep Brain Stimulation, Parkinson Disease, Apraxia, Motor
- Being tested
- Deep brain stimulation effect on apraxia
- Medical subject headings
- Parkinson Disease, Apraxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulation effect on apraxiaDevice
We will evaluate the effect of DBS on apraxia
| Study group | Role | What they receive |
|---|---|---|
| PD DBS | Patients with Parkinson's disease and deep brain stimulation Receives: Device: Deep brain stimulation effect on apraxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate for the presence or absence of ideomotor apraxia in PD patients
Evaluate the effect of DBS on ideomotor apraxia in PD patients. We will assess the TULIA screening assessment:
General instruction: "Seven gestures are demonstrated in a mirror fashion, imitate them as precisely as possible"
- Bring thumb extended on forehead, other fingers point upwards
- Wipe dust from shoulder Additional instruction: "For the next five gestures, imagine holding a tool or an object in hand, don't use your fingers as a tool"
- Drink from a glass
- Smoke a cigarette
- Use a hammer
- Use scissors
- Use a stamp to postmark Pantomime General instruction: "Now gestures are asked. Listen very carefully and perform them as precisely as possible"
- "Show as if someone is crazy" 9 . "Make a threatening sign"
Additional instruction: "Again, imagine holding a tool or an object in hand, don't use the fingers"
- "Brush your teeth" 11. "Comb your hair" 12. "Use a screwdriver"
Measured: Up to 1 hour
Evaluate for the presence or absence of ideational apraxia in PD patients
Evaluate the effect of DBS on Ideational apraxia in PD patients. We will assess this via the picture sequencing test. The outcome will be a binary (yes/no) result based on the testing.
In this test, there is an activity that is represented by 4 black and white photographs: 3 of the photographs show a set of objects, tools, and actions needed to complete a step of the activity, and 1 photograph shows the completed task. The 4 photographs are arranged randomly, 1 per quadrant on an 8 1/2"×11" sheet of white paper. Participants are required to touch each picture in the correct sequence needed to complete each activity.
Measured: Up to 1 hour
Evaluate for the presence or absence of limb-kinetic apraxia in PD patients
Evaluate the effect of DBS on limb-kinetic apraxia in PD patients. We will assess this via the coin rotation test.
Coin rotation test The subject is asked to take a coin and rotate it 180 degrees between their thumb, index and middle fingers as fast as they can twenty times. They will rotate the coin so that the thumb pushes the bottom part of the coin up and away from themselves. The task will be repeated 3 times for each hand. Each task is timed.
Measured: Up to 30 minutes
Evaluate for the presence or absence of limb-kinetic apraxia in PD patients
Evaluate the effect of DBS on limb-kinetic apraxia in PD patients. We will assess this via the grooved pegboard test.
Grooved Pegboard The Grooved Pegboard is a manipulative dexterity test. This unit consists of 25 holes with randomly positioned slots. Pegs, which have a key along one side, must be rotated to match the hole before the can be inserted. The pegboard is placed in mid-line with the subject so that the board is at the edge of the table and peg tray immediately above the board.
All the pegs are the same. They have a groove, that is, a round side and a square side and so do the holes in the boards. What you must do is match the groove of the peg with the groove of the board and put these pegs into the holes like this.
Measured: Up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Jun 2021
- Primary completion28 Jan 2024
- Study completion28 Jan 2024
Why it stopped: Insufficient Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Deep Brain StimulationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bhavana Patel, DO, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725773
- Sponsor's protocol ID
- IRB202001999
- Acronym
- Apraxia DBS
- Status last verified
- Jul 2025
- First submitted
- 13 Jan 2021
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Agostoni E, Coletti A, Orlando G, Tredici G. Apraxia in deep cerebral lesions. J Neurol Neurosurg Psychiatry. 1983 Sep;46(9):804-8. doi: 10.1136/jnnp.46.9.804.
PubMed 6619888Basso A, Luzzatti C, Spinnler H. Is ideomotor apraxia the outcome of damage to well-defined regions of the left hemisphere? Neuropsychological study of CAT correlation. J Neurol Neurosurg Psychiatry. 1980 Feb;43(2):118-26. doi: 10.1136/jnnp.43.2.118.
PubMed 7359149Bolognini N, Convento S, Banco E, Mattioli F, Tesio L, Vallar G. Improving ideomotor limb apraxia by electrical stimulation of the left posterior parietal cortex. Brain. 2015 Feb;138(Pt 2):428-39. doi: 10.1093/brain/awu343. Epub 2014 Dec 5.
PubMed 25481002Cavaco S, Anderson SW, Correia M, Magalhaes M, Pereira C, Tuna A, Taipa R, Pinto P, Pinto C, Cruz R, Lima AB, Castro-Caldas A, da Silva AM, Damasio H. Task-specific contribution of the human striatum to perceptual-motor skill learning. J Clin Exp Neuropsychol. 2011 Jan;33(1):51-62. doi: 10.1080/13803395.2010.493144. Epub 2010 Jul 5.
PubMed 20603739Falchook AD, Decio D, Williamson JB, Okun MS, Malaty IA, Rodriguez RL, Heilman KM. Alternate but do not swim: a test for executive motor dysfunction in Parkinson disease. J Int Neuropsychol Soc. 2011 Jul;17(4):702-8. doi: 10.1017/S1355617711000609.
PubMed 22882811Foki T, Vanbellingen T, Lungu C, Pirker W, Bohlhalter S, Nyffeler T, Kraemmer J, Haubenberger D, Fischmeister FP, Auff E, Hallett M, Beisteiner R. Limb-kinetic apraxia affects activities of daily living in Parkinson's disease: a multi-center study. Eur J Neurol. 2016 Aug;23(8):1301-7. doi: 10.1111/ene.13021. Epub 2016 May 1.
PubMed 27132653Gebhardt A, Vanbellingen T, Baronti F, Kersten B, Bohlhalter S. Poor dopaminergic response of impaired dexterity in Parkinson's disease: Bradykinesia or limb kinetic apraxia? Mov Disord. 2008 Sep 15;23(12):1701-6. doi: 10.1002/mds.22199.
PubMed 18649388Heilman KM, Rothi LJ, Valenstein E. Two forms of ideomotor apraxia. Neurology. 1982 Apr;32(4):342-6. doi: 10.1212/wnl.32.4.342.
PubMed 7199656Okun MS. Deep-brain stimulation for Parkinson's disease. N Engl J Med. 2012 Oct 18;367(16):1529-38. doi: 10.1056/NEJMct1208070. No abstract available.
PubMed 23075179Quencer K, Okun MS, Crucian G, Fernandez HH, Skidmore F, Heilman KM. Limb-kinetic apraxia in Parkinson disease. Neurology. 2007 Jan 9;68(2):150-1. doi: 10.1212/01.wnl.0000250331.35912.a5. Epub 2006 Dec 6.
PubMed 17151340Vanbellingen T, Lungu C, Lopez G, Baronti F, Muri R, Hallett M, Bohlhalter S. Short and valid assessment of apraxia in Parkinson's disease. Parkinsonism Relat Disord. 2012 May;18(4):348-50. doi: 10.1016/j.parkreldis.2011.11.023. Epub 2011 Dec 16.
PubMed 22177625Vanbellingen T, Hofmanner D, Kubel S, Bohlhalter S. Limb Kinetic Apraxia Is an Independent Predictor for Quality of Life in Parkinson's Disease. Mov Disord Clin Pract. 2018 Jan 25;5(2):156-159. doi: 10.1002/mdc3.12572. eCollection 2018 Mar-Apr.
PubMed 30363441Watson RT, Fleet WS, Gonzalez-Rothi L, Heilman KM. Apraxia and the supplementary motor area. Arch Neurol. 1986 Aug;43(8):787-92. doi: 10.1001/archneur.1986.00520080035016.
PubMed 3729758
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apraxia in Parkinson's Disease Patients With Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT04725773
- Acronym / sponsor ID
- Apraxia DBS / IRB202001999
- Conditions
- Deep Brain Stimulation, Parkinson Disease, Apraxia, Motor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient Enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 28 Jan 2024 (actual)
- Study completion
- 28 Jan 2024 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Deep brain stimulation (DBS) of the subthalamic nucleus or globus pallidus internus can improve motor symptoms Parkinson's disease (PD). However, it is not known whether DBS can help reduce the signs and symptoms of the limb-kinetic, ideomotor or ideational apraxia associated with PD or if apraxia can exist as a stimulation induced side effect from DBS therapy. In this study, we look to conduct a pilot study to examine the feasibility of characterizing the prevalence of apraxia in PD patients with chronic, stable DBS.
Detailed description
This will be a pilot study designed to assess the safety and feasibility of an apraxia testing protocol in chronically implanted PD DBS patients. We hypothesize that apraxia testing in the DBS ON and OFF states will be a safe and well-tolerated testing protocol. We also hypothesize that DBS will affect the severity of limb-kinetic, ideomotor and ideational apraxia in PD patients. This will set the foundation for larger prospective trials to further characterize apraxia in relation to DBS and whether or not DBS programming can modulate this phenomenon.
In this study, we will recruit 60 PD patients with chronic, stable DBS of either the subthalamic nucleus (STN) or globus pallidus interna (GPi). Both unilateral and bilateral DBS patients are eligible for this study. For this study, "chronic, stable DBS" will be defined as patients who have had at least 6 months of optimization programming at the University of Florida. The subjects will be recruited to the Fixel clinic for a 1-day study visit in the medication ON state. The patients will undergo testing for limb-kinetic, ideomotor and ideational apraxia of both upper extremities in the DBS ON state at home therapeutic settings.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD DBS | – | Device: Deep brain stimulation effect on apraxiaPatients with Parkinson's disease and deep brain stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease who underwent deep brain stimulation for help of their motor symptoms.
Key inclusion criteria (3 listed)
- Patients with PD as defined by the UK Brain Bank Criteria
- Male or female, ages 18 to 80 years old
- Chronically implanted DBS of either the STN or GPi for a minimum of 6 months
Key exclusion criteria (5 listed)
- Other neurological diagnoses (e.g. Alzheimer's disease, atypical parkinsonism, stroke)
- History of previous neurosurgical intervention that was not DBS
- Patients with DBS of targets other than the STN or GPi, or leads in both targets
- Patients in whom there is poor manual dexterity for a reason other than PD (e.g. orthopedic injury, amputation)
- Patients with a diagnosis of PD dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep brain stimulation effect on apraxiaWe will evaluate the effect of DBS on apraxia | Device | PD DBS |
Primary outcome
Evaluate for the presence or absence of ideomotor apraxia in PD patients
Time frame: Up to 1 hour
Evaluate the effect of DBS on ideomotor apraxia in PD patients. We will assess the TULIA screening assessment: General instruction: "Seven gestures are demonstrated in a mirror fashion, imitate them as precisely as possible" 1. Bring thumb extended on forehead, other fingers point upwards 2. Wipe dust from shoulder Additional instruction: "For the next five gestures, imagine holding a tool or an object in hand, don't use your fingers as a tool" 3. Drink from a glass 4. Smoke a cigarette 5. Use a hammer 6. Use scissors 7. Use a stamp to postmark Pantomime General instruction: "Now gestures are asked. Listen very carefully and perform them as precisely as possible" 8. "Show as if someone is crazy" 9 . "Make a threatening sign" Additional instruction: "Again, imagine holding a tool or an object in hand, don't use the fingers" 10. "Brush your teeth" 11. "Comb your hair" 12. "Use a screwdriver"
Evaluate for the presence or absence of ideational apraxia in PD patients
Time frame: Up to 1 hour
Evaluate the effect of DBS on Ideational apraxia in PD patients. We will assess this via the picture sequencing test. The outcome will be a binary (yes/no) result based on the testing. In this test, there is an activity that is represented by 4 black and white photographs: 3 of the photographs show a set of objects, tools, and actions needed to complete a step of the activity, and 1 photograph shows the completed task. The 4 photographs are arranged randomly, 1 per quadrant on an 8 1/2"×11" sheet of white paper. Participants are required to touch each picture in the correct sequence needed to complete each activity.
Evaluate for the presence or absence of limb-kinetic apraxia in PD patients
Time frame: Up to 30 minutes
Evaluate the effect of DBS on limb-kinetic apraxia in PD patients. We will assess this via the coin rotation test. Coin rotation test The subject is asked to take a coin and rotate it 180 degrees between their thumb, index and middle fingers as fast as they can twenty times. They will rotate the coin so that the thumb pushes the bottom part of the coin up and away from themselves. The task will be repeated 3 times for each hand. Each task is timed.
Evaluate for the presence or absence of limb-kinetic apraxia in PD patients
Time frame: Up to 30 minutes
Evaluate the effect of DBS on limb-kinetic apraxia in PD patients. We will assess this via the grooved pegboard test. Grooved Pegboard The Grooved Pegboard is a manipulative dexterity test. This unit consists of 25 holes with randomly positioned slots. Pegs, which have a key along one side, must be rotated to match the hole before the can be inserted. The pegboard is placed in mid-line with the subject so that the board is at the edge of the table and peg tray immediately above the board. All the pegs are the same. They have a groove, that is, a round side and a square side and so do the holes in the boards. What you must do is match the groove of the peg with the groove of the board and put these pegs into the holes like this.
Results and safety
The study was stopped early (reason given: Insufficient Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Background: PubMed 6619888Agostoni E, Coletti A, Orlando G, Tredici G. Apraxia in deep cerebral lesions. J Neurol Neurosurg Psychiatry. 1983 Sep;46(9):804-8. doi: 10.1136/jnnp.46.9.804.
- Background: PubMed 7359149Basso A, Luzzatti C, Spinnler H. Is ideomotor apraxia the outcome of damage to well-defined regions of the left hemisphere? Neuropsychological study of CAT correlation. J Neurol Neurosurg Psychiatry. 1980 Feb;43(2):118-26. doi: 10.1136/jnnp.43.2.118.
- Background: PubMed 25481002Bolognini N, Convento S, Banco E, Mattioli F, Tesio L, Vallar G. Improving ideomotor limb apraxia by electrical stimulation of the left posterior parietal cortex. Brain. 2015 Feb;138(Pt 2):428-39. doi: 10.1093/brain/awu343. Epub 2014 Dec 5.
- Background: PubMed 20603739Cavaco S, Anderson SW, Correia M, Magalhaes M, Pereira C, Tuna A, Taipa R, Pinto P, Pinto C, Cruz R, Lima AB, Castro-Caldas A, da Silva AM, Damasio H. Task-specific contribution of the human striatum to perceptual-motor skill learning. J Clin Exp Neuropsychol. 2011 Jan;33(1):51-62. doi: 10.1080/13803395.2010.493144. Epub 2010 Jul 5.
- Background: PubMed 22882811Falchook AD, Decio D, Williamson JB, Okun MS, Malaty IA, Rodriguez RL, Heilman KM. Alternate but do not swim: a test for executive motor dysfunction in Parkinson disease. J Int Neuropsychol Soc. 2011 Jul;17(4):702-8. doi: 10.1017/S1355617711000609.
- Background: PubMed 27132653Foki T, Vanbellingen T, Lungu C, Pirker W, Bohlhalter S, Nyffeler T, Kraemmer J, Haubenberger D, Fischmeister FP, Auff E, Hallett M, Beisteiner R. Limb-kinetic apraxia affects activities of daily living in Parkinson's disease: a multi-center study. Eur J Neurol. 2016 Aug;23(8):1301-7. doi: 10.1111/ene.13021. Epub 2016 May 1.
- Background: PubMed 18649388Gebhardt A, Vanbellingen T, Baronti F, Kersten B, Bohlhalter S. Poor dopaminergic response of impaired dexterity in Parkinson's disease: Bradykinesia or limb kinetic apraxia? Mov Disord. 2008 Sep 15;23(12):1701-6. doi: 10.1002/mds.22199.
- Background: PubMed 7199656Heilman KM, Rothi LJ, Valenstein E. Two forms of ideomotor apraxia. Neurology. 1982 Apr;32(4):342-6. doi: 10.1212/wnl.32.4.342.
- Background: PubMed 23075179Okun MS. Deep-brain stimulation for Parkinson's disease. N Engl J Med. 2012 Oct 18;367(16):1529-38. doi: 10.1056/NEJMct1208070. No abstract available.
- Background: PubMed 17151340Quencer K, Okun MS, Crucian G, Fernandez HH, Skidmore F, Heilman KM. Limb-kinetic apraxia in Parkinson disease. Neurology. 2007 Jan 9;68(2):150-1. doi: 10.1212/01.wnl.0000250331.35912.a5. Epub 2006 Dec 6.
- Background: PubMed 22177625Vanbellingen T, Lungu C, Lopez G, Baronti F, Muri R, Hallett M, Bohlhalter S. Short and valid assessment of apraxia in Parkinson's disease. Parkinsonism Relat Disord. 2012 May;18(4):348-50. doi: 10.1016/j.parkreldis.2011.11.023. Epub 2011 Dec 16.
- Background: PubMed 30363441Vanbellingen T, Hofmanner D, Kubel S, Bohlhalter S. Limb Kinetic Apraxia Is an Independent Predictor for Quality of Life in Parkinson's Disease. Mov Disord Clin Pract. 2018 Jan 25;5(2):156-159. doi: 10.1002/mdc3.12572. eCollection 2018 Mar-Apr.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bhavana Patel, DO principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Brain Stimulation and Parkinson Disease, run by University of Florida at 1 site in United States.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Insufficient Enrollment). Results are not available in the source record.
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?
Evaluate for the presence or absence of ideomotor apraxia in PD patients (time frame: Up to 1 hour). The study lists 4 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 NCT04725773, which also lists 13 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 16 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.