Post-stroke Shoulder PainNCT05601921
Repetitive Transcranial Magnetic Stimulation in Hemiplegic Shoulder Pain
A study testing Repetitive transcranial magnetic stimulation in people with Post-stroke Shoulder Pain, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Shoulder pain after stroke is one of the most common complications of stroke. Underlying mechanisms of shoulder pain after stroke still completely is not clarified. Central sensitization and neuropathic pain mechanisms are thought to play a role in the etiology of pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-stroke Shoulder Pain
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 14 Jul 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-70
- Presence of ischemic or hemorrhagic stroke confirmed by MRI
- Having a stroke for the first time
- Presence of stroke in the subacute or chronic period
- Presence of subacute or chronic shoulder pain starting after stroke and Numeric Rating Scale >4
- If the patient is receiving analgesic treatment, the pain persists despite at least one week of analgesic treatment.
- Patients who agreed to participate by signing the informed permission form.
Who cannot join
- Presence of history of surgical intervention on the shoulder joint
- Presence of history of peri/intraarticular injection into the shoulder joint
- Rotator cuff injury or tendonitis, frozen shoulder, etc. that they had diagnosed/treated before stroke
- Presence of full-thickness rotator cuff tear visualized by US
- Presence of >3 spasticity in the upper extremity defined according to the Modified Ashworth Scale
- Presence of severe cognitive impairment
Show all 15Show fewer
- Presence of aphasia
- History of malignancy or systemic rheumatic disease
- Alcohol or drug addiction
- History of psychiatric illness such as major depression/personality disorders
- History of epilepsy or taking medication due to epilepsy
- Diagnosed with dementia
- Pregnancy and breastfeeding
- Having received TMS treatment before
- Having a clinical condition (metallic implant, cardiac pace, head trauma, cranial operation history…) that would be a contraindication for TMS
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Katip Çelebi Üniversitesi
Izmir, Karabağlar / İ̇zmi̇r, 35360
About this study
Official title: Effects of High Frequency Repetitive Transcranial Magnetic Stimulation on Pain and Disability in Patients With Post-stroke Shoulder Pain
Shoulder pain after stroke is one of the most common complications of stroke. Underlying mechanisms of shoulder pain after stroke still completely is not clarified. Central sensitization and neuropathic pain mechanisms are thought to play a role in the etiology of pain. Research on repetitive transcranial magnetic stimulation therapy in the treatment of pain in which somatosensory sensitization mechanisms play a role is increasing day by day. There are studies showing that application of high-frequency rTMS to the primary motor cortex provides effective pain relieving in most of painful conditions. However, data in the literature regarding the application of high-frequency rTMS in shoulder pain after stroke are very limited. There is only one clinical study related to this. More studies are needed in this area.In our study, it was aimed to examine the effects of this treatment protocol applied on the effects of pain on daily activities, upper extremity disability, anxiety, depression, range of motion and neurophysiological parameters.
Read the detailed description
Stroke is one of the most common causes of disability and death in the adult population. Many complications such as depression, shoulder pain, falls, urinary system infections can develop after stroke. These complications prevent stroke rehabilitation and delay functional recovery. Hemiplegic shoulder pain is also one of the most common complications after stroke. Many possible causes underlying its development have been described; It may develop due to many pathologies such as rotator cuff lesions, biceps tendinopathy, soft tissue disorders such as myofascial pain, glenohumeral subluxation, spasticity, changes in peripheral and central nervous system activity. Many options such as joint range of motion (ROM) exercises, electrical stimulation, analgesics, intra-articular injections of corticosteroids, botulinum toxin-A injections are used in the management of pain. However, current treatment options provide limited pain relief, which causes chronic pain in many patients. This suggests that post-stroke shoulder pain is not only due to simple nociceptive stimuli from the shoulder joint, but also includes nociceptive and neuropathic mechanisms related to both the peripheral and central nervous systems. In recent years, TMS studies have been conducted in many painful conditions, which are thought to have complex pain mechanisms in the pathogenesis, and its effectiveness has been reported.In our study, it was aimed to examine the effects of this treatment protocol applied on the effects of pain on daily activities, upper extremity disability, anxiety, depression, range of motion and neurophysiological parameters.
- Conditions
- Post-stroke Shoulder Pain
- Being tested
- Repetitive transcranial magnetic stimulation, Sham Repetitive transcranial magnetic stimulation
- Keywords
- Stroke, Shoulder pain, Repetitive transcranial magnetic stimulation
- Medical subject headings
- Stroke, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationDevice
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive intervention that uses magnetic fields to stimulate nerve cells to improve the symptoms of a variety of disorders. In recent years, TMS studies have been conducted in many painful conditions, which are thought to have complex pain mechanisms in the pathogenesis, and its effectiveness has been reported.
Sham Repetitive transcranial magnetic stimulationDevice
Sham Repetitive transcranial magnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation group | Experimental | Patients in the real stimulation group will receive rTMS treatment to the motor cortex (M1) of the affected hemisphere at a frequency of 5 Hz, once a day for 3 weeks and a total of 15 sessions. The application will be performed with Neurosoft-Neuro MS / D device. Before each session, the patient's resting motor threshold (RMT) value will be determined. RMT will be detected by obtaining a motor evoked potential of >50 μV amplitude on electromyography recording of the contralateral first dorsal interosseous muscle in at least five out of 10 stimulations to the primary motor cortex.The stimulus intensity to be used in the treatment will be set as 90% of the motor threshold for the affected motor cortex and 100% of the motor threshold for the unaffected motor cortex.One session of stimulation will last for a total of 20 minutes and a total of 1000 pulses in the form of 5 Hz stimulation. Receives: Device: Repetitive transcranial magnetic stimulation |
| Sham stimulation group | Sham comparator | Fifteen sessions of sham repetitive transcranial magnetic stimulation (rTMS) treatment will be applied to the lesional primary motor cortex. The application will be performed with Neurosoft-Neuro MS / D device. The probe of the device will be held perpendicular to the motor cortex and operated from the lowest operating power of 1, so that the device makes the same sounds as the active application. Receives: Device: Sham Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Numeric Rating Scale
The NRS is an 11-point numerical scale that evaluates the intensity of pain in adults from 0 to 10. 0 represents no pain and 10 represents the worst possible pain.
Measured: (1) at the beginning of the treatment, (2) at the 1st week, (3) at the 2nd week, (4) at the end of the treatment (3rd week), (5)one month after the end of the treatment
Secondary outcomes (4)
Change from baseline in the Brief Pain Inventory - Pain on Daily Activities
The BPI is a two-part multidimensional pain assessment questionnaire that evaluates pain intensity and the effect of pain on daily activities (general activity, mood, walking ability, work, relationships with other people, sleep, enjoyment of life).
Measured: (1) at the beginning of the treatment, (2) at the end of the treatment (3rd week), (3) one month after the end of the treatment
Change from baseline in the Quick DASH
It is an outcome measure developed for the evaluation of patients with upper extremity musculoskeletal disorders.
Measured: (1) at the beginning of the treatment, (2) at the end of the treatment (3rd week), (3) one month after the end of the treatment
Change from baseline in the Hospital Anxiety and Depression Scale
The hospital anxiety and depression scale (HADS) was developed to screen for depression and anxiety in hospitalized patients
Measured: (1) at the beginning of the treatment , (2) at the end of the treatment (3rd week)
Change from baseline in the shoulder joint range of motion
Maximum painless passive range of motion values were measured as abduction adduction internal and external rotation with a goniometer in the supine position.
Measured: (1) at the beginning of the treatment, (2) at the end of the treatment (3rd week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Oct 2022
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post-stroke Shoulder PainStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yagmur Aydin, Izmir Katip Celebi University
- Investigators
- Ayhan Aşkın, Professor, Study director, Izmir Katip Çelebi UniversityYağmur Aydın, M.D., Principal investigator, Izmir Katip Çelebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601921
- Sponsor's protocol ID
- 2021-TDU-TIPF-0013
- Status last verified
- Jul 2023
- First submitted
- 20 Oct 2022
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergen DC, Silberberg D. Nervous system disorders: a global epidemic. Arch Neurol. 2002 Jul;59(7):1194-6. doi: 10.1001/archneur.59.7.1194.
PubMed 12117370Langhorne P, Stott DJ, Robertson L, MacDonald J, Jones L, McAlpine C, Dick F, Taylor GS, Murray G. Medical complications after stroke: a multicenter study. Stroke. 2000 Jun;31(6):1223-9. doi: 10.1161/01.str.31.6.1223.
PubMed 10835436McLean DE. Medical complications experienced by a cohort of stroke survivors during inpatient, tertiary-level stroke rehabilitation. Arch Phys Med Rehabil. 2004 Mar;85(3):466-9. doi: 10.1016/s0003-9993(03)00484-2.
PubMed 15031834Kalichman L, Ratmansky M. Underlying pathology and associated factors of hemiplegic shoulder pain. Am J Phys Med Rehabil. 2011 Sep;90(9):768-80. doi: 10.1097/PHM.0b013e318214e976.
PubMed 21430513Viana R, Pereira S, Mehta S, Miller T, Teasell R. Evidence for therapeutic interventions for hemiplegic shoulder pain during the chronic stage of stroke: a review. Top Stroke Rehabil. 2012 Nov-Dec;19(6):514-22. doi: 10.1310/tsr1906-514.
PubMed 23192716Roosink M, Renzenbrink GJ, Geurts AC, Ijzerman MJ. Towards a mechanism-based view on post-stroke shoulder pain: theoretical considerations and clinical implications. NeuroRehabilitation. 2012;30(2):153-65. doi: 10.3233/NRE-2012-0739.
PubMed 22430581Choi GS, Chang MC. Effects of high-frequency repetitive transcranial magnetic stimulation on reducing hemiplegic shoulder pain in patients with chronic stoke: a randomized controlled trial. Int J Neurosci. 2018 Feb;128(2):110-116. doi: 10.1080/00207454.2017.1367682. Epub 2017 Oct 2.
PubMed 28805107
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Frequency Repetitive Transcranial Magnetic Stimulation on Pain and Disability in Patients With Post-stroke Shoulder Pain
- ClinicalTrials.gov ID
- NCT05601921
- Acronym / sponsor ID
- 2021-TDU-TIPF-0013
- Conditions
- Post-stroke Shoulder Pain
- Keywords
- Stroke, Shoulder pain, Repetitive transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 1 Nov 2022 (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.
Shoulder pain after stroke is one of the most common complications of stroke. Underlying mechanisms of shoulder pain after stroke still completely is not clarified. Central sensitization and neuropathic pain mechanisms are thought to play a role in the etiology of pain. Research on repetitive transcranial magnetic stimulation therapy in the treatment of pain in which somatosensory sensitization mechanisms play a role is increasing day by day. There are studies showing that application of high-frequency rTMS to the primary motor cortex provides effective pain relieving in most of painful conditions. However, data in the literature regarding the application of high-frequency rTMS in shoulder pain after stroke are very limited. There is only one clinical study related to this. More studies are needed in this area.In our study, it was aimed to examine the effects of this treatment protocol applied on the effects of pain on daily activities, upper extremity disability, anxiety, depression, range of motion and neurophysiological parameters.
Detailed description
Stroke is one of the most common causes of disability and death in the adult population. Many complications such as depression, shoulder pain, falls, urinary system infections can develop after stroke. These complications prevent stroke rehabilitation and delay functional recovery. Hemiplegic shoulder pain is also one of the most common complications after stroke. Many possible causes underlying its development have been described; It may develop due to many pathologies such as rotator cuff lesions, biceps tendinopathy, soft tissue disorders such as myofascial pain, glenohumeral subluxation, spasticity, changes in peripheral and central nervous system activity. Many options such as joint range of motion (ROM) exercises, electrical stimulation, analgesics, intra-articular injections of corticosteroids, botulinum toxin-A injections are used in the management of pain. However, current treatment options provide limited pain relief, which causes chronic pain in many patients. This suggests that post-stroke shoulder pain is not only due to simple nociceptive stimuli from the shoulder joint, but also includes nociceptive and neuropathic mechanisms related to both the peripheral and central nervous systems. In recent years, TMS studies have been conducted in many painful conditions, which are thought to have complex pain mechanisms in the pathogenesis, and its effectiveness has been reported.In our study, it was aimed to examine the effects of this treatment protocol applied on the effects of pain on daily activities, upper extremity disability, anxiety, depression, range of motion and neurophysiological parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation group | Experimental | Device: Repetitive transcranial magnetic stimulationPatients in the real stimulation group will receive rTMS treatment to the motor cortex (M1) of the affected hemisphere at a frequency of 5 Hz, once a day for 3 weeks and a total of 15 sessions. The application will be performed with Neurosoft-Neuro MS / D device. Before each session, the patient's resting motor threshold (RMT) value will be determined. RMT will be detected by obtaining a motor evoked potential of >50 μV amplitude on electromyography recording of the contralateral first dorsal interosseous muscle in at least five out of 10 stimulations to the primary motor cortex.The stimulus intensity to be used in the treatment will be set as 90% of the motor threshold for the affected motor cortex and 100% of the motor threshold for the unaffected motor cortex.One session of stimulation will last for a total of 20 minutes and a total of 1000 pulses in the form of 5 Hz stimulation. |
| Sham stimulation group | Sham comparator | Device: Sham Repetitive transcranial magnetic stimulationFifteen sessions of sham repetitive transcranial magnetic stimulation (rTMS) treatment will be applied to the lesional primary motor cortex. The application will be performed with Neurosoft-Neuro MS / D device. The probe of the device will be held perpendicular to the motor cortex and operated from the lowest operating power of 1, so that the device makes the same sounds as the active application. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being between the ages of 18-70
- Presence of ischemic or hemorrhagic stroke confirmed by MRI
- Having a stroke for the first time
- Presence of stroke in the subacute or chronic period
- Presence of subacute or chronic shoulder pain starting after stroke and Numeric Rating Scale >4
Key exclusion criteria (15 listed)
- Presence of history of surgical intervention on the shoulder joint
- Presence of history of peri/intraarticular injection into the shoulder joint
- Rotator cuff injury or tendonitis, frozen shoulder, etc. that they had diagnosed/treated before stroke
- Presence of full-thickness rotator cuff tear visualized by US
- Presence of >3 spasticity in the upper extremity defined according to the Modified Ashworth Scale
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulationRepetitive transcranial magnetic stimulation (rTMS) is a noninvasive intervention that uses magnetic fields to stimulate nerve cells to improve the symptoms of a variety of disorders. In recent years, TMS studies have been conducted in many painful conditions, which are thought to have complex pain mechanisms in the pathogenesis, and its effectiveness has been reported. | Device | Active stimulation group |
| Sham Repetitive transcranial magnetic stimulationSham Repetitive transcranial magnetic stimulation | Device | Sham stimulation group |
Primary outcome
Change from baseline in the Numeric Rating Scale
Time frame: (1) at the beginning of the treatment, (2) at the 1st week, (3) at the 2nd week, (4) at the end of the treatment (3rd week), (5)one month after the end of the treatment
The NRS is an 11-point numerical scale that evaluates the intensity of pain in adults from 0 to 10. 0 represents no pain and 10 represents the worst possible pain.
4 secondary outcomes
Change from baseline in the Brief Pain Inventory - Pain on Daily Activities
Time frame: (1) at the beginning of the treatment, (2) at the end of the treatment (3rd week), (3) one month after the end of the treatment
Change from baseline in the Quick DASH
Time frame: (1) at the beginning of the treatment, (2) at the end of the treatment (3rd week), (3) one month after the end of the treatment
Change from baseline in the Hospital Anxiety and Depression Scale
Time frame: (1) at the beginning of the treatment , (2) at the end of the treatment (3rd week)
Change from baseline in the shoulder joint range of motion
Time frame: (1) at the beginning of the treatment, (2) at the end of the treatment (3rd week)
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 17 Jul 2023.
- Background: PubMed 12117370Bergen DC, Silberberg D. Nervous system disorders: a global epidemic. Arch Neurol. 2002 Jul;59(7):1194-6. doi: 10.1001/archneur.59.7.1194.
- Background: PubMed 10835436Langhorne P, Stott DJ, Robertson L, MacDonald J, Jones L, McAlpine C, Dick F, Taylor GS, Murray G. Medical complications after stroke: a multicenter study. Stroke. 2000 Jun;31(6):1223-9. doi: 10.1161/01.str.31.6.1223.
- Background: PubMed 15031834McLean DE. Medical complications experienced by a cohort of stroke survivors during inpatient, tertiary-level stroke rehabilitation. Arch Phys Med Rehabil. 2004 Mar;85(3):466-9. doi: 10.1016/s0003-9993(03)00484-2.
- Background: PubMed 21430513Kalichman L, Ratmansky M. Underlying pathology and associated factors of hemiplegic shoulder pain. Am J Phys Med Rehabil. 2011 Sep;90(9):768-80. doi: 10.1097/PHM.0b013e318214e976.
- Background: PubMed 23192716Viana R, Pereira S, Mehta S, Miller T, Teasell R. Evidence for therapeutic interventions for hemiplegic shoulder pain during the chronic stage of stroke: a review. Top Stroke Rehabil. 2012 Nov-Dec;19(6):514-22. doi: 10.1310/tsr1906-514.
- Background: PubMed 22430581Roosink M, Renzenbrink GJ, Geurts AC, Ijzerman MJ. Towards a mechanism-based view on post-stroke shoulder pain: theoretical considerations and clinical implications. NeuroRehabilitation. 2012;30(2):153-65. doi: 10.3233/NRE-2012-0739.
- Background: PubMed 28805107Choi GS, Chang MC. Effects of high-frequency repetitive transcranial magnetic stimulation on reducing hemiplegic shoulder pain in patients with chronic stoke: a randomized controlled trial. Int J Neurosci. 2018 Feb;128(2):110-116. doi: 10.1080/00207454.2017.1367682. Epub 2017 Oct 2.
- Individual participant dataSharing planned: No
Related trials for Post-stroke Shoulder Pain
Not yet recruiting
Effectiveness of High-intensity Peripheral Magnetic Stimulation on Hemiplegic Shoulder Pain After Stroke
Hemiplegic Shoulder Pain
RecruitingPhase 2
Myofascial Dysfunction in Post Stroke Shoulder Pain
Stroke
Not yet recruiting
Ultrasound-Guided Pulsed Radiofrequency Versus Phenol Neurolysis for Post-Stroke Hemiplegic Shoulder Pain
Post-Stroke Hemiplegic Shoulder Pain
Not yet recruiting
Focal Vibration Therapy in Post-stroke Shoulder Pain
Stroke, Hemiplegic Shoulder Pain
Recruiting
To Evaluate the Therapeutic Effect of Laser Acupuncture in Patients With Acute or Subacute Post Stroke Shoulder Pain
Post Stroke Shoulder Pain
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.
Ayhan Aşkın, Professor study director
Izmir Katip Çelebi University
Yağmur Aydın, M.D. principal investigator
Izmir Katip Çelebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation in people with Post-stroke Shoulder Pain, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 7 inclusion and 15 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 17 Jul 2023. 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 Turkey (Türkiye). 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. 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?
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?
Change from baseline in the Numeric Rating Scale (time frame: (1) at the beginning of the treatment, (2) at the 1st week, (3) at the 2nd week, (4) at the end of the treatment (3rd week), (5)one month after the end of the treatment). 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 NCT05601921, which also lists 7 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 17 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.