Upper Extremity ParesisNCT06147167
Effects of Individualized iTBS on Upper Limb Function After Stroke
A study testing individualized intermittent theta burst sitmulation (iTBS) and standard iTBS in people with Upper Extremity Paresis and Stroke, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The primary objective of this clinical study is to assess the comparative efficacy of individualized intermittent theta burst stimulation (iTBS) in contrast to standard iTBS for individuals post-stroke experiencing upper limb impairment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Extremity Paresis, Stroke
- What is being tested?
- individualized intermittent theta burst sitmulation (iTBS) and standard iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Sep 2026
- 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
- aging from 18-80
- diagnosed as first-happened stroke,duration of the disease ranged from 1-3 months
- upper extremity impairment
- with mini-mental state examination>15
- agree to participate in this study and sigh the informed consent
Who cannot join
- with stroke history
- have metal device within the body
- with history of upper extremity trauma,fracture, and/or burn
- serious conditions and can not finish the examination and treatment
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this clinical study is to assess the comparative efficacy of individualized intermittent theta burst stimulation (iTBS) in contrast to standard iTBS for individuals post-stroke experiencing upper limb impairment. The key inquiries addressed in this study encompass:
Enhancement of Upper Limb Function: The primary investigation seeks to determine whether individualized iTBS yields superior improvements in upper limb functionality compared to standard iTBS.
Read more
Long-Term Effects: This study endeavors to explore the sustained effects of both individualized and standard iTBS on upper limb function over an extended duration.
Neural Mechanisms Investigation: Functional near-infrared spectroscopy (fNIRS) will be employed to elucidate the neural mechanisms underlying the impact of iTBS on the enhancement of upper limb function.
Post-stroke individuals with upper limb impairment will undergo pre-treatment assessments, including motor function evaluations and fNIRS tests. Subsequently, they will be randomized into three groups: individualized iTBS, standard iTBS, and sham stimulation. Participants will undergo post-treatment assessments and follow-up evaluations.
The research team aims to discern disparities in the efficacy of different iTBS modalities. The central hypothesis posits that individualized iTBS will demonstrate superior efficacy in enhancing post-stroke upper limb function, with sustained effects persisting for a minimum of one month.
Read the detailed description
This research constitutes a single-center, double-blind, randomized controlled study. Upon enrollment, baseline information is established through the assessment of upper limb function using the Fugl Meyer Assessment (FMA), the modified Rankin Scale, the Action Research Arm Test (ARAT), and a handgrip test. Additionally, functional near-infrared spectroscopy (fNIRS) is employed to assess brain function, providing insights into the patient's motor network.
Participants in the study are randomly assigned to one of three groups: individualized iTBS, standard iTBS, and sham stimulation. All participants undergo physical therapy and occupational therapy tailored to their functional evaluation. After three weeks of treatment, participants are required to complete the aforementioned assessments, with a follow-up evaluation scheduled one month post-treatment.
- Conditions
- Upper Extremity Paresis, Stroke
- Being tested
- individualized intermittent theta burst sitmulation (iTBS), standard iTBS, sham stimulation
- Keywords
- intermittent theta burst stimulation;, upper extremity paresis;, functional nearinfrared spectroscopy
- Medical subject headings
- Paresis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individualized intermittent theta burst sitmulation (iTBS)Device
Also called physical therapy, occupational therapy
Participants undergo daily sessions of individualized intermittent theta-burst stimulation (iTBS) administered with the MagStim stimulator (Rapid2, MagStim, Whiteland, United States). The intervention spans five days a week and extends over a three-week period. In this group, participants receive a personalized iTBS protocol comprising three pulses of stimulation delivered at 50 Hz, repeated every 200 ms. The stimulation frequency is tailored based on the electroencephalogram (EEG) results and is administered every 10 seconds, with a total duration of 190 seconds. The treatment is administered once a day for five days a week and continues for three weeks, with an immediate cessation in case of any discomfort. This study design ensures a meticulous and tailored approach to iTBS administration.
standard iTBSDevice
Also called physical therapy, occupational therapy
The MagStim stimulator (Rapid2, MagStim, Whiteland, United States) was employed in the current study. The intermittent theta-burst stimulation (iTBS) protocol utilized three pulses of stimulation delivered at a frequency of 50 Hz, with a repetition rate of every 200 ms. These pulses were organized into 2-second trains, repeated every 10 seconds, resulting in a cumulative duration of 190 seconds (equivalent to a total of 600 pulses). Notably, the administration of the treatment ceased promptly in the event of any participant discomfort.
sham stimulationDevice
Also called physical therapy, occupational therapy
The device and protocol are identical to the standard iTBS, with the only difference being the orientation of the coil, which is perpendicular to the scalp.
| Study group | Role | What they receive |
|---|---|---|
| indvidualized iTBS | Experimental | In this arm of the study, participants undergo individualized intermittent theta burst stimulation (iTBS) subsequent to encephalography (EEG) testing. Three electrodes are strategically positioned on the first dorsal interosseous (FDI) hotspot to record the resting theta frequency, which is subsequently utilized as the theta frequency for theta burst stimulation (TBS). The participants receive this treatment regimen once daily, five times a week, over a total duration of three weeks. Receives: Device: individualized intermittent theta burst sitmulation (iTBS) |
| standard iTBS | Active comparator | In this particular arm of the study, participants also undergo an initial electroencephalography (EEG) procedure. Subsequently, intermittent theta burst stimulation (iTBS) is administered using the standard theta burst stimulation frequency of 5Hz. The participants receive this treatment once daily, five times a week, over a total duration of three weeks. Receives: Device: standard iTBS |
| sham iTBS | Sham comparator | In this arm, the treatment procedure is similar to the standard iTBS unless the coil is perpendicular to the scalp. Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment-upper extremity
Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had stroke. The FMA motor assessments for the upper fucntion with maximum score 66 points, including relflex activity, flexor synergy, extensor synergy, movement combining synergies, movement out of synergy,normal reflex, wrist function, hand function and coordination/speed, and sensory assessment.
Measured: Befor and after the treatment, and 1 month after the treatment.
Secondary outcomes (4)
modified Rankin Scale
The Modified Rankin Scale (mRS) assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death.
Measured: Befor and after the treatment, and 1 month after the treatment.
Action Research Arm Test
The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations.Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).
Measured: Befor and after the treatment, and 1 month after the treatment.
handrip test
Hand grip test will be finished with a dynamometer.
Measured: Befor and after the treatment, and 1 month after the treatment.
functional nearinfrared spectroscopy
The functional nearinfrared spectroscopy (fNIRS) is used to explore the motor network of the participants.
Measured: Befor and after the treatment, and 1 month after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start1 May 2024 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
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 Upper Extremity ParesisStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yonghui Wang, professor, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147167
- Sponsor's protocol ID
- KYLL-202307-023
- Status last verified
- Jul 2023
- First submitted
- 19 Nov 2023
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kong G, Wei L, Wang J, Zhu C, Tang Y. The therapeutic potential of personalized connectivity-guided transcranial magnetic stimulation target over group-average target for depression. Brain Stimul. 2022 Sep-Oct;15(5):1063-1064. doi: 10.1016/j.brs.2022.07.054. Epub 2022 Aug 2. No abstract available.
PubMed 35931377Klooster DCW, Ferguson MA, Boon PAJM, Baeken C. Personalizing Repetitive Transcranial Magnetic Stimulation Parameters for Depression Treatment Using Multimodal Neuroimaging. Biol Psychiatry Cogn Neurosci Neuroimaging. 2022 Jun;7(6):536-545. doi: 10.1016/j.bpsc.2021.11.004. Epub 2021 Nov 17.
PubMed 34800726Ferrarelli F, Phillips ML. Examining and Modulating Neural Circuits in Psychiatric Disorders With Transcranial Magnetic Stimulation and Electroencephalography: Present Practices and Future Developments. Am J Psychiatry. 2021 May 1;178(5):400-413. doi: 10.1176/appi.ajp.2020.20071050. Epub 2021 Mar 3.
PubMed 33653120Siddiqi SH, Trapp NT, Shahim P, Hacker CD, Laumann TO, Kandala S, Carter AR, Brody DL. Individualized Connectome-Targeted Transcranial Magnetic Stimulation for Neuropsychiatric Sequelae of Repetitive Traumatic Brain Injury in a Retired NFL Player. J Neuropsychiatry Clin Neurosci. 2019 Summer;31(3):254-263. doi: 10.1176/appi.neuropsych.18100230. Epub 2019 Apr 3.
PubMed 30945588Cassidy JM, Wodeyar A, Wu J, Kaur K, Masuda AK, Srinivasan R, Cramer SC. Low-Frequency Oscillations Are a Biomarker of Injury and Recovery After Stroke. Stroke. 2020 May;51(5):1442-1450. doi: 10.1161/STROKEAHA.120.028932. Epub 2020 Apr 17.
PubMed 32299324Cash RFH, Cocchi L, Anderson R, Rogachov A, Kucyi A, Barnett AJ, Zalesky A, Fitzgerald PB. A multivariate neuroimaging biomarker of individual outcome to transcranial magnetic stimulation in depression. Hum Brain Mapp. 2019 Nov 1;40(16):4618-4629. doi: 10.1002/hbm.24725. Epub 2019 Jul 22.
PubMed 31332903Ge R, Humaira A, Gregory E, Alamian G, MacMillan EL, Barlow L, Todd R, Nestor S, Frangou S, Vila-Rodriguez F. Predictive Value of Acute Neuroplastic Response to rTMS in Treatment Outcome in Depression: A Concurrent TMS-fMRI Trial. Am J Psychiatry. 2022 Jul;179(7):500-508. doi: 10.1176/appi.ajp.21050541. Epub 2022 May 18.
PubMed 35582784
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Individualized iTBS on Upper Limb Function After Stroke
- ClinicalTrials.gov ID
- NCT06147167
- Acronym / sponsor ID
- KYLL-202307-023
- Conditions
- Upper Extremity Paresis, Stroke
- Keywords
- intermittent theta burst stimulation;, upper extremity paresis;, functional nearinfrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 27 Nov 2023 (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.
The primary objective of this clinical study is to assess the comparative efficacy of individualized intermittent theta burst stimulation (iTBS) in contrast to standard iTBS for individuals post-stroke experiencing upper limb impairment. The key inquiries addressed in this study encompass:
Enhancement of Upper Limb Function: The primary investigation seeks to determine whether individualized iTBS yields superior improvements in upper limb functionality compared to standard iTBS.
Long-Term Effects: This study endeavors to explore the sustained effects of both individualized and standard iTBS on upper limb function over an extended duration.
Neural Mechanisms Investigation: Functional near-infrared spectroscopy (fNIRS) will be employed to elucidate the neural mechanisms underlying the impact of iTBS on the enhancement of upper limb function.
Post-stroke individuals with upper limb impairment will undergo pre-treatment assessments, including motor function evaluations and fNIRS tests. Subsequently, they will be randomized into three groups: individualized iTBS, standard iTBS, and sham stimulation. Participants will undergo post-treatment assessments and follow-up evaluations.
The research team aims to discern disparities in the efficacy of different iTBS modalities. The central hypothesis posits that individualized iTBS will demonstrate superior efficacy in enhancing post-stroke upper limb function, with sustained effects persisting for a minimum of one month.
Detailed description
This research constitutes a single-center, double-blind, randomized controlled study. Upon enrollment, baseline information is established through the assessment of upper limb function using the Fugl Meyer Assessment (FMA), the modified Rankin Scale, the Action Research Arm Test (ARAT), and a handgrip test. Additionally, functional near-infrared spectroscopy (fNIRS) is employed to assess brain function, providing insights into the patient's motor network.
Participants in the study are randomly assigned to one of three groups: individualized iTBS, standard iTBS, and sham stimulation. All participants undergo physical therapy and occupational therapy tailored to their functional evaluation. After three weeks of treatment, participants are required to complete the aforementioned assessments, with a follow-up evaluation scheduled one month post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| indvidualized iTBS | Experimental | Device: individualized intermittent theta burst sitmulation (iTBS)In this arm of the study, participants undergo individualized intermittent theta burst stimulation (iTBS) subsequent to encephalography (EEG) testing. Three electrodes are strategically positioned on the first dorsal interosseous (FDI) hotspot to record the resting theta frequency, which is subsequently utilized as the theta frequency for theta burst stimulation (TBS). The participants receive this treatment regimen once daily, five times a week, over a total duration of three weeks. |
| standard iTBS | Active comparator | Device: standard iTBSIn this particular arm of the study, participants also undergo an initial electroencephalography (EEG) procedure. Subsequently, intermittent theta burst stimulation (iTBS) is administered using the standard theta burst stimulation frequency of 5Hz. The participants receive this treatment once daily, five times a week, over a total duration of three weeks. |
| sham iTBS | Sham comparator | Device: sham stimulationIn this arm, the treatment procedure is similar to the standard iTBS unless the coil is perpendicular to the scalp. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aging from 18-80
- diagnosed as first-happened stroke,duration of the disease ranged from 1-3 months
- upper extremity impairment
- with mini-mental state examination>15
- agree to participate in this study and sigh the informed consent
Key exclusion criteria (4 listed)
- with stroke history
- have metal device within the body
- with history of upper extremity trauma,fracture, and/or burn
- serious conditions and can not finish the examination and treatment
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 |
|---|---|---|
| individualized intermittent theta burst sitmulation (iTBS)Also: physical therapy, occupational therapyParticipants undergo daily sessions of individualized intermittent theta-burst stimulation (iTBS) administered with the MagStim stimulator (Rapid2, MagStim, Whiteland, United States). The intervention spans five days a week and extends over a three-week period. In this group, participants receive a personalized iTBS protocol comprising three pulses of stimulation delivered at 50 Hz, repeated every 200 ms. The stimulation frequency is tailored based on the electroencephalogram (EEG) results and is administered every 10 seconds, with a total duration of 190 seconds. The treatment is administered once a day for five days a week and continues for three weeks, with an immediate cessation in case of any discomfort. This study design ensures a meticulous and tailored approach to iTBS administration. | Device | indvidualized iTBS |
| standard iTBSAlso: physical therapy, occupational therapyThe MagStim stimulator (Rapid2, MagStim, Whiteland, United States) was employed in the current study. The intermittent theta-burst stimulation (iTBS) protocol utilized three pulses of stimulation delivered at a frequency of 50 Hz, with a repetition rate of every 200 ms. These pulses were organized into 2-second trains, repeated every 10 seconds, resulting in a cumulative duration of 190 seconds (equivalent to a total of 600 pulses). Notably, the administration of the treatment ceased promptly in the event of any participant discomfort. | Device | standard iTBS |
| sham stimulationAlso: physical therapy, occupational therapyThe device and protocol are identical to the standard iTBS, with the only difference being the orientation of the coil, which is perpendicular to the scalp. | Device | sham iTBS |
Primary outcome
Fugl-Meyer Assessment-upper extremity
Time frame: Befor and after the treatment, and 1 month after the treatment.
Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had stroke. The FMA motor assessments for the upper fucntion with maximum score 66 points, including relflex activity, flexor synergy, extensor synergy, movement combining synergies, movement out of synergy,normal reflex, wrist function, hand function and coordination/speed, and sensory assessment.
4 secondary outcomes
modified Rankin Scale
Time frame: Befor and after the treatment, and 1 month after the treatment.
Action Research Arm Test
Time frame: Befor and after the treatment, and 1 month after the treatment.
handrip test
Time frame: Befor and after the treatment, and 1 month after the treatment.
functional nearinfrared spectroscopy
Time frame: Befor and after the treatment, and 1 month after the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Background: PubMed 35931377Kong G, Wei L, Wang J, Zhu C, Tang Y. The therapeutic potential of personalized connectivity-guided transcranial magnetic stimulation target over group-average target for depression. Brain Stimul. 2022 Sep-Oct;15(5):1063-1064. doi: 10.1016/j.brs.2022.07.054. Epub 2022 Aug 2. No abstract available.
- Background: PubMed 34800726Klooster DCW, Ferguson MA, Boon PAJM, Baeken C. Personalizing Repetitive Transcranial Magnetic Stimulation Parameters for Depression Treatment Using Multimodal Neuroimaging. Biol Psychiatry Cogn Neurosci Neuroimaging. 2022 Jun;7(6):536-545. doi: 10.1016/j.bpsc.2021.11.004. Epub 2021 Nov 17.
- Background: PubMed 33653120Ferrarelli F, Phillips ML. Examining and Modulating Neural Circuits in Psychiatric Disorders With Transcranial Magnetic Stimulation and Electroencephalography: Present Practices and Future Developments. Am J Psychiatry. 2021 May 1;178(5):400-413. doi: 10.1176/appi.ajp.2020.20071050. Epub 2021 Mar 3.
- Background: PubMed 30945588Siddiqi SH, Trapp NT, Shahim P, Hacker CD, Laumann TO, Kandala S, Carter AR, Brody DL. Individualized Connectome-Targeted Transcranial Magnetic Stimulation for Neuropsychiatric Sequelae of Repetitive Traumatic Brain Injury in a Retired NFL Player. J Neuropsychiatry Clin Neurosci. 2019 Summer;31(3):254-263. doi: 10.1176/appi.neuropsych.18100230. Epub 2019 Apr 3.
- Background: PubMed 32299324Cassidy JM, Wodeyar A, Wu J, Kaur K, Masuda AK, Srinivasan R, Cramer SC. Low-Frequency Oscillations Are a Biomarker of Injury and Recovery After Stroke. Stroke. 2020 May;51(5):1442-1450. doi: 10.1161/STROKEAHA.120.028932. Epub 2020 Apr 17.
- Background: PubMed 31332903Cash RFH, Cocchi L, Anderson R, Rogachov A, Kucyi A, Barnett AJ, Zalesky A, Fitzgerald PB. A multivariate neuroimaging biomarker of individual outcome to transcranial magnetic stimulation in depression. Hum Brain Mapp. 2019 Nov 1;40(16):4618-4629. doi: 10.1002/hbm.24725. Epub 2019 Jul 22.
- Background: PubMed 35582784Ge R, Humaira A, Gregory E, Alamian G, MacMillan EL, Barlow L, Todd R, Nestor S, Frangou S, Vila-Rodriguez F. Predictive Value of Acute Neuroplastic Response to rTMS in Treatment Outcome in Depression: A Concurrent TMS-fMRI Trial. Am J Psychiatry. 2022 Jul;179(7):500-508. doi: 10.1176/appi.ajp.21050541. Epub 2022 May 18.
- Individual participant dataSharing planned: No
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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.
Yonghui Wang, professor principal investigator
Qilu Hospital of Shandong 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 individualized intermittent theta burst sitmulation (iTBS) and standard iTBS in people with Upper Extremity Paresis and Stroke, run by Qilu Hospital of Shandong University at 1 site in China.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yonghui Wang, professor (86-18560083581, yonghuiw6606@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment-upper extremity (time frame: Befor and after the treatment, and 1 month after 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 NCT06147167, 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 22 Apr 2024.