Left-sided Hemiplegia Affecting Dominant Side as Late Effect of Cerebrovascular AccidentAVCPOSTIMNCT01677091
Balance Rehabilitation With Sensory Recalibration After Stroke
A study testing Cervical vibration, Prism adaptation and Conventional rehabilitation in people with Left-sided Hemiplegia Affecting Dominant Side as Late Effect of Cerebrovascular Accident, run by Rennes University Hospital at 8 sites in France.
Trial summary
The main objective of this study is to test the effectiveness of a rehabilitation program with cervical vibration and/or prism adaptation in patients with left hemiplegia on balance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Left-sided Hemiplegia Affecting Dominant Side as Late Effect of Cerebrovascular Accident
- What is being tested?
- Cervical vibration, Prism adaptation and Conventional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 8 sitesFrance
- Study dates
- 5 May 2013to 14 Oct 2019
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Right unilateral supratentorial ischemic or hemorrhagic lesion
- Adult (age ≥ 18 years) under 80 years
- Stroke
- older than 9 months
- with or without hemianopsia
- with or without visuospatial hemineglect
Show all 10Show fewer
- The first symptomatic episode
- Standing balance ≥ 30 sec unaided
- Percentage of weight rests on the hemiplegic lower limb below 40% of body weight (on a platform of strength)
- Written informed consent of the patient or a member of his entourage (in the case of patients with motor difficulties)
Who cannot join
- Orthopedic, rheumatologic or visual disorders affecting the distribution of the center of pressure while standing
- Visual disorder that does not allow assessment of the longitudinal axis or visual straight ahead
- Ischemic or hemorrhagic brain stem lesion
- Trouble for understanding protocol procedures
- Inclusion Criteria for the healthy volunteers (ancillary study) :
- Age ≥ 18 years, right-handed, sex and age-matched (+/- 5 years) to the patients of the coordinating center
Show all 10Show fewer
- Able to get an MRI
- With no imbalance
- With no visual disorder impacting the repartition of the center of pression when standing up, or that does not allow assessment of the longitudinal axis or visual straight ahead
- Written informed consent
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU Grenoble
Grenoble, 38701
CHU Lille
Lille, 59000
CHU Lyon
Lyon
IRF Nancy
Nancy
CHU Lariboisière-Saint Louis Paris
Paris, 75010
Centre de Rééducation de Kerpape
Ploemeur, 56270
CHU Reims
Reims, 51100
CHU Rennes-Pontchaillou
Rennes, 35000
About this study
Official title: Effectiveness of a Balance Rehabilitation Program With Sensory Recalibration After Stroke: A Randomized Controlled Trial.
The main objective of this study is to test the effectiveness of a rehabilitation program with cervical vibration and/or prism adaptation in patients with left hemiplegia on balance.
Read the detailed description
Imbalance is particularly severe after a Cerebral Vascular Accident because they not only limit the capacity of transfer and are a source of falls but also represent an obstacle to the acquisition of autonomy.
When the brain lesion is located in the right hemisphere, the prognosis in terms of equilibrium is worse probably because of the presence of disorders of spatial cognition. These disorders of spatial cognition are manifested by a distortion of the mental representation of space and body in space that probably cause a deviation of the position of the center of pression on platform. This component of balance disorders secondary to disruption of spatial cognition, do not benefit at present from specific rehabilitative treatment despite the severity of the consequences.
But the application of sensory manipulations has proven its effectiveness on visuospatial neglect that is another disorder of spatial cognition closed to the pathophysiology of balance disorders after right brain lesion. Sensory manipulations decrease the distortion of internal representations of the body in space by restoring the symmetry of sensory inputs. Some of these manipulations (visual manipulation by wearing prisms and proprioceptive manipulations) are also effective on the immediate correction of postural imbalances on force platform and disorders of spatial perception.
We therefore believe that the approach by repeated sensory manipulation is a new promising way of research for the rehabilitative treatment of balance disorders secondary to disorders of spatial cognition. As the mechanisms of action and the structures involved during proprioceptive vibration of neck muscles and during visual prism adaptation are different, we believe that the combination of these two types of sensory manipulations will permit to obtain a greater and longer lasting effect than a lonely manipulation. The concomitant evaluation of the bias on postural platform and the perception of the body axis will allow us to assess the impact of such rehabilitation on the disorders of spatial representation and so better understand the mechanisms of action of sensory manipulations.
The main objective of this study is to test the effectiveness of a rehabilitation program with cervical vibration (V) and / or prism adaptation (P) in patients with left hemiplegia on balance at the end of the intervention (day14).
Secondary objectives are to test:
- The immediate effect (day 0) on force platform evaluation of balance,
- Maintaining the gain at 3 months and 6 months on balance,
- Effectiveness at day 14 on negligence
- Maintaining the gain at 3 months and 6 months on neglect,
- Effectiveness at day 14 on functional abilities,
- Maintaining the gain at 3 months and 6 months on functional abilities,
- Understanding the mechanisms of action of each of the sensory manipulations by assessing changes in perceptions of space, after rehabilitation programs (day 14) and at 3 months and 6 months.
- To evaluate the evolution of motility, sensitivity and spasticity in the various assessments.
During the 15 days rehabilitation performed for the study, the upper and lower limbs motor rehabilitation will last less than one hour and a half, and will exclude instrumental techniques of balance rehabilitation, sensory manipulations, virtual reality, strain-induced therapy.
Moreover, an ancillary study will be performed to study the immediate neurofunctional effect of vibratory stimulation, in right brain-damaged patients with imbalance and in healthy volunteers, through the assessment of cerebral activation changes in MRI. The secondary objectives of this ancillary study are to test the neurofunctional effect of repeated vibratory stimulation in right brain-damaged patients, describe the relationship between cerebral activation changes and evolution of balance, and describe the areas of the brain activated by vibratory stimulation.
- Being tested
- Cervical vibration, Prism adaptation, Conventional rehabilitation
- Keywords
- Balance,Hemiplegia,Cervical vibration,Prism adaptation,Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical vibrationOther
Vibration of neck muscles during 10 minutes
Prism adaptationOther
Prism adaptation during 10 minutes
Conventional rehabilitationOther
conventional rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | This group will benefit from conventional rehabilitation Receives: Other: Conventional rehabilitation |
| Cervical vibration | Experimental | This group will benefit from a daily 20 minutes session, with vibration of neck muscles during 10 minutes Receives: Other: Cervical vibration |
| Prism adaptation | Experimental | This group will benefit from a daily 20 minutes session, with prism adaptation during 10 minutes Receives: Other: Prism adaptation |
| Cervical vibration + Prism adaptation | Experimental | This group will receive a daily 30 minutes session, with cervical vibration during 10 minutes + prism adaptation during 10 minutes Receives: Other: Cervical vibration; Other: Prism adaptation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the deviation of the mean position of center of pressure (CP) (eyes closed) on the mediolateral axis (mm) assessed by posturography after intervention.
Measured: Day 14
Secondary outcomes (4)
Evaluation of balance
- Postural Assessment Scale for Stroke
- Scale for Contraversive Pushing
- Berg Balance Scale
- Timed Up and Go
- Measurement performed on the platform of strength:
- surface of the center of mass displacement
- deviation of the mean position of the center pressure on the anteroposterior axis
- standard deviation of the average displacement of the center pressure on the mediolateral axis and the anteroposterior axis,
- percentage of support on the hemiplegic lower limb.
Measured: Day 0, Day 14, Month 3, Month 6
Evaluation of functional capacity
- Barthel Index (Day 0, Day 14, Month 3, Month 6)
- Number of hours of help at home (Month 3, Month 6)
- Total Duration of hospitalization since the Cerebral Vascular Accident (Month 3, Month 6)
Measured: Day 0, Day 14, Month 3, Month 6
Evaluation of negligence
- Bell test,
- Bisection test,
- Scale of Catherine Bergego,
- OTA test
- Test of bodily neglect.
Measured: Day 0, Day 14, Month 3, Month 6
Understanding the mechanisms of sensory manipulations
- Evaluation of longitudinal axis by a fluorescent bar movement in front of the patient through a computerized system.
- Haptic Straight Ahead using a graduated table on which the subject moves his hand blindfolded.
Measured: Day 0, Day 14, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study start5 May 2013
- Primary completion14 Oct 2019
- Study completion14 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Left-sided Hemiplegia Affecting Dominant Side as Late Effect of Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle BONAN, PU PH, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677091
- Sponsor's protocol ID
- 2012-A00667-36
- Acronym
- AVCPOSTIM
- Status last verified
- May 2023
- First submitted
- 29 Aug 2012
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Leplaideur S, Moulinet-Raillon A, Duche Q, Chochina L, Jamal K, Ferre JC, Bannier E, Bonan I. The Neural Bases of Egocentric Spatial Representation for Extracorporeal and Corporeal Tasks: An fMRI Study. Brain Sci. 2021 Jul 22;11(8):963. doi: 10.3390/brainsci11080963.
PubMed 34439582Jamal K, Leplaideur S, Rousseau C, Cordillet S, Raillon AM, Butet S, Cretual A, Bonan I. The effects of repetitive neck-muscle vibration on postural disturbances after a chronic stroke. Neurophysiol Clin. 2020 Sep;50(4):269-278. doi: 10.1016/j.neucli.2020.01.005. Epub 2020 Mar 31.
PubMed 32245547Foussat E, Painchaud S, Leplaideur S, Rousseau C, Viallard L, Bonan I, Jamal K. Factors associated with Severe Balance Impairment After Right-Hemisphere Stroke: The Role of Spatial Neglect and Lateropulsion: A Secondary Analysis of Multicenter Cross-Sectional Study POSTIM. NeuroRehabilitation. 2026 Oct 29:10538135261494072. doi: 10.1177/10538135261494072. Online ahead of print.
PubMed 42957620Painchaud S, Duche Q, Allart E, Leplaideur S, Bannier E, Bonan I. Investigating the Neural Bases of Egocentric Spatial Reference Frame After Right-Hemisphere Stroke: Brain Lesions and Disconnectome Analyses of Subjective Straight Ahead and Longitudinal Body Axis Misperception. Hum Brain Mapp. 2026 Oct 1;47(14):e70637. doi: 10.1002/hbm.70637.
PubMed 42768733Jamal K, Leplaideur S, Rousseau C, Foussat E, Painchaud S, Viallard L, Bonan I. Identifying the Factors With Later Standing Acquisition in Patients With a Right-Hemisphere Stroke: A Cross-Sectional Study Using POSTIM Data. Ann Rehabil Med. 2026 Jun;50(3):160-167. doi: 10.5535/arm.250125. Epub 2026 Jun 29.
PubMed 42392229Leplaideur S, Allart E, Chochina L, Perennou D, Rode G, Boyer FC, Paysant J, Yelnik A, Jamal K, Duche Q, Morcet JF, Laviolle B, Combes B, Bannier E, Bonan I. Neck muscle vibration and prism adaptation fail to improve balance disturbances after stroke: A multicentre randomised controlled study. Ann Phys Rehabil Med. 2024 Oct;67(7):101871. doi: 10.1016/j.rehab.2024.101871. Epub 2024 Aug 21.
PubMed 39173550
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Balance Rehabilitation Program With Sensory Recalibration After Stroke: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01677091
- Acronym / sponsor ID
- AVCPOSTIM / 2012-A00667-36
- Keywords
- Balance,Hemiplegia,Cervical vibration,Prism adaptation,Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 5 May 2013 (actual)
- Primary completion
- 14 Oct 2019 (actual)
- Study completion
- 14 Oct 2019 (actual)
- First posted
- 31 Aug 2012 (estimated)
- 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.
The main objective of this study is to test the effectiveness of a rehabilitation program with cervical vibration and/or prism adaptation in patients with left hemiplegia on balance.
Detailed description
Imbalance is particularly severe after a Cerebral Vascular Accident because they not only limit the capacity of transfer and are a source of falls but also represent an obstacle to the acquisition of autonomy.
When the brain lesion is located in the right hemisphere, the prognosis in terms of equilibrium is worse probably because of the presence of disorders of spatial cognition. These disorders of spatial cognition are manifested by a distortion of the mental representation of space and body in space that probably cause a deviation of the position of the center of pression on platform. This component of balance disorders secondary to disruption of spatial cognition, do not benefit at present from specific rehabilitative treatment despite the severity of the consequences.
But the application of sensory manipulations has proven its effectiveness on visuospatial neglect that is another disorder of spatial cognition closed to the pathophysiology of balance disorders after right brain lesion. Sensory manipulations decrease the distortion of internal representations of the body in space by restoring the symmetry of sensory inputs. Some of these manipulations (visual manipulation by wearing prisms and proprioceptive manipulations) are also effective on the immediate correction of postural imbalances on force platform and disorders of spatial perception.
We therefore believe that the approach by repeated sensory manipulation is a new promising way of research for the rehabilitative treatment of balance disorders secondary to disorders of spatial cognition. As the mechanisms of action and the structures involved during proprioceptive vibration of neck muscles and during visual prism adaptation are different, we believe that the combination of these two types of sensory manipulations will permit to obtain a greater and longer lasting effect than a lonely manipulation. The concomitant evaluation of the bias on postural platform and the perception of the body axis will allow us to assess the impact of such rehabilitation on the disorders of spatial representation and so better understand the mechanisms of action of sensory manipulations.
The main objective of this study is to test the effectiveness of a rehabilitation program with cervical vibration (V) and / or prism adaptation (P) in patients with left hemiplegia on balance at the end of the intervention (day14).
Secondary objectives are to test:
- The immediate effect (day 0) on force platform evaluation of balance,
- Maintaining the gain at 3 months and 6 months on balance,
- Effectiveness at day 14 on negligence
- Maintaining the gain at 3 months and 6 months on neglect,
- Effectiveness at day 14 on functional abilities,
- Maintaining the gain at 3 months and 6 months on functional abilities,
- Understanding the mechanisms of action of each of the sensory manipulations by assessing changes in perceptions of space, after rehabilitation programs (day 14) and at 3 months and 6 months.
- To evaluate the evolution of motility, sensitivity and spasticity in the various assessments.
During the 15 days rehabilitation performed for the study, the upper and lower limbs motor rehabilitation will last less than one hour and a half, and will exclude instrumental techniques of balance rehabilitation, sensory manipulations, virtual reality, strain-induced therapy.
Moreover, an ancillary study will be performed to study the immediate neurofunctional effect of vibratory stimulation, in right brain-damaged patients with imbalance and in healthy volunteers, through the assessment of cerebral activation changes in MRI. The secondary objectives of this ancillary study are to test the neurofunctional effect of repeated vibratory stimulation in right brain-damaged patients, describe the relationship between cerebral activation changes and evolution of balance, and describe the areas of the brain activated by vibratory stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Conventional rehabilitationThis group will benefit from conventional rehabilitation |
| Cervical vibration | Experimental | Other: Cervical vibrationThis group will benefit from a daily 20 minutes session, with vibration of neck muscles during 10 minutes |
| Prism adaptation | Experimental | Other: Prism adaptationThis group will benefit from a daily 20 minutes session, with prism adaptation during 10 minutes |
| Cervical vibration + Prism adaptation | Experimental | Other: Cervical vibration, Other: Prism adaptationThis group will receive a daily 30 minutes session, with cervical vibration during 10 minutes + prism adaptation during 10 minutes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Right unilateral supratentorial ischemic or hemorrhagic lesion
- Adult (age ≥ 18 years) under 80 years
- Stroke
- The first symptomatic episode
- Standing balance ≥ 30 sec unaided
Key exclusion criteria (10 listed)
- Orthopedic, rheumatologic or visual disorders affecting the distribution of the center of pressure while standing
- Visual disorder that does not allow assessment of the longitudinal axis or visual straight ahead
- Ischemic or hemorrhagic brain stem lesion
- Trouble for understanding protocol procedures
- Age ≥ 18 years, right-handed, sex and age-matched (+/- 5 years) to the patients of the coordinating center
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 |
|---|---|---|
| Cervical vibrationVibration of neck muscles during 10 minutes | Other | Cervical vibration, Cervical vibration + Prism adaptation |
| Prism adaptationPrism adaptation during 10 minutes | Other | Cervical vibration + Prism adaptation, Prism adaptation |
| Conventional rehabilitationconventional rehabilitation | Other | Control group |
Primary outcome
The primary outcome is the deviation of the mean position of center of pressure (CP) (eyes closed) on the mediolateral axis (mm) assessed by posturography after intervention.
Time frame: Day 14
4 secondary outcomes
Evaluation of balance
Time frame: Day 0, Day 14, Month 3, Month 6
Evaluation of functional capacity
Time frame: Day 0, Day 14, Month 3, Month 6
Evaluation of negligence
Time frame: Day 0, Day 14, Month 3, Month 6
Understanding the mechanisms of sensory manipulations
Time frame: Day 0, Day 14, Month 3, Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Results publication: PubMed 34439582Leplaideur S, Moulinet-Raillon A, Duche Q, Chochina L, Jamal K, Ferre JC, Bannier E, Bonan I. The Neural Bases of Egocentric Spatial Representation for Extracorporeal and Corporeal Tasks: An fMRI Study. Brain Sci. 2021 Jul 22;11(8):963. doi: 10.3390/brainsci11080963.
- Results publication: PubMed 32245547Jamal K, Leplaideur S, Rousseau C, Cordillet S, Raillon AM, Butet S, Cretual A, Bonan I. The effects of repetitive neck-muscle vibration on postural disturbances after a chronic stroke. Neurophysiol Clin. 2020 Sep;50(4):269-278. doi: 10.1016/j.neucli.2020.01.005. Epub 2020 Mar 31.
- Derived from this study: PubMed 42957620Foussat E, Painchaud S, Leplaideur S, Rousseau C, Viallard L, Bonan I, Jamal K. Factors associated with Severe Balance Impairment After Right-Hemisphere Stroke: The Role of Spatial Neglect and Lateropulsion: A Secondary Analysis of Multicenter Cross-Sectional Study POSTIM. NeuroRehabilitation. 2026 Oct 29:10538135261494072. doi: 10.1177/10538135261494072. Online ahead of print.
- Derived from this study: PubMed 42768733Painchaud S, Duche Q, Allart E, Leplaideur S, Bannier E, Bonan I. Investigating the Neural Bases of Egocentric Spatial Reference Frame After Right-Hemisphere Stroke: Brain Lesions and Disconnectome Analyses of Subjective Straight Ahead and Longitudinal Body Axis Misperception. Hum Brain Mapp. 2026 Oct 1;47(14):e70637. doi: 10.1002/hbm.70637.
- Derived from this study: PubMed 42392229Jamal K, Leplaideur S, Rousseau C, Foussat E, Painchaud S, Viallard L, Bonan I. Identifying the Factors With Later Standing Acquisition in Patients With a Right-Hemisphere Stroke: A Cross-Sectional Study Using POSTIM Data. Ann Rehabil Med. 2026 Jun;50(3):160-167. doi: 10.5535/arm.250125. Epub 2026 Jun 29.
- Derived from this study: PubMed 39173550Leplaideur S, Allart E, Chochina L, Perennou D, Rode G, Boyer FC, Paysant J, Yelnik A, Jamal K, Duche Q, Morcet JF, Laviolle B, Combes B, Bannier E, Bonan I. Neck muscle vibration and prism adaptation fail to improve balance disturbances after stroke: A multicentre randomised controlled study. Ann Phys Rehabil Med. 2024 Oct;67(7):101871. doi: 10.1016/j.rehab.2024.101871. Epub 2024 Aug 21.
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.
Isabelle BONAN, PU PH principal investigator
Rennes University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical vibration, Prism adaptation and Conventional rehabilitation in people with Left-sided Hemiplegia Affecting Dominant Side as Late Effect of Cerebrovascular Accident, run by Rennes University Hospital at 8 sites in France.
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 10 inclusion and 10 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: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome is the deviation of the mean position of center of pressure (CP) (eyes closed) on the mediolateral axis (mm) assessed by posturography after intervention. (time frame: Day 14). 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 NCT01677091, which also lists 6 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 24 May 2023.