AphasiaPART-CNNCT07912242
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
A study testing Cathodal cerebellar transcranial direct current stimulation and Computerized language therapy in people with Aphasia and Stroke, run by Johns Hopkins University at 1 site in United States.
Trial summary
This pilot study tests whether a mild form of brain stimulation to the cerebellum, combined with computer-based language therapy, helps people recover language after a stroke when a poor natural recovery is predicted. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Cathodal cerebellar transcranial direct current stimulation and Computerized language therapy
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in the Johns Hopkins longitudinal stroke and aphasia study (IRB NA_00042097)
- Consented to future contact for research studies
- Predicted to have poor language recovery from acute-phase data, defined as a predicted Western Aphasia Battery-Revised Aphasia Quotient below 93.8 at 12 months post-stroke
- Ischemic left hemisphere stroke
- Aphasia with naming impairment on the Western Aphasia Battery-Revised
- Approaching 3 months post-stroke at enrollment
- Fluent speaker of English by self-report
- Age 18 or older
Who cannot join
- Lesion in the right cerebellum
- Previous neurological disorder other than stroke affecting the brain, or any neurodegenerative or psychiatric disorder
- Seizures during the previous 6 months
- Uncorrected visual or hearing loss by self-report
- Use of medications that lower the seizure threshold (e.g., methylphenidate)
- Use of N-methyl-D-aspartate (NMDA) receptor antagonists (e.g., memantine)
Show all 9Show fewer
- History of brain surgery or any metal in the head
- Severely impaired auditory comprehension (below 2 on the Western Aphasia Battery-Revised Auditory Verbal Comprehension sub-score)
- Severely limited verbal output (below 2 on the Western Aphasia Battery-Revised Spontaneous Speech rating)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Johns Hopkins Hospital, Phipps Building
Baltimore, Maryland, 21287
Manuel J Marte, PhD, CCC-SLP, 845-598-6911, mmarte1@jh.edu
About this study
Official title: Predicting Aphasia Recovery and Testing Cerebellar Neuromodulation (PART-CN): A Pilot Wait-List Randomized Trial of Cathodal Cerebellar Transcranial Direct Current Stimulation Plus Computerized Language Therapy in Stroke Survivors Predicted to Have Poor Language Recovery
This pilot study tests whether a mild form of brain stimulation to the cerebellum, combined with computer-based language therapy, helps people recover language after a stroke when a poor natural recovery is predicted.
People already taking part in a Johns Hopkins study of stroke and language recovery, whose early data suggest the aphasia is unlikely to resolve without treatment, are invited about 3 months after the stroke. Half begin 15 treatment sessions right away and half begin about 3 months later. Each session pairs 25 minutes of transcranial direct current stimulation (tDCS) over the right cerebellum with 45 to 60 minutes of language exercises, with a speech-language pathologist present.
The main question is whether language ability, measured with the Western Aphasia Battery-Revised Aphasia Quotient, improves more by 6 months after stroke in the group treated first than in the group still waiting. The study also checks how accurately a machine learning model, built from data collected in the first days after stroke, predicted each person's language ability 12 months after stroke.
Read the detailed description
About one third of people with aphasia after stroke respond poorly to language therapy, and current clinical tools cannot identify these individuals early, when recovery is steepest. This study pairs a recovery prediction model with a targeted treatment.
Aim 1: A machine learning model trained on acute-phase data from the parent longitudinal study (Johns Hopkins IRB NA_00042097; neuroimaging, cognitive-linguistic testing, demographics) predicts each participant's 12-month Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ). Participants predicted to remain below 93.8 (aphasia not expected to resolve) are eligible. Prediction accuracy is evaluated prospectively against observed 12-month scores (mean absolute error, correlation, and sensitivity, specificity, positive predictive value and F1 for the below-93.8 classification).
Aim 2: Eligible participants are randomized 1:1 to early intervention (treatment beginning about 3 months post-stroke) or wait-list control (usual care until about 6 months post-stroke, then the same treatment). Treatment is 15 sessions, up to 5 per week over about 3 to 5 weeks. In each session, cathodal tDCS (2 mA, 25 minutes; cathode over the right cerebellum, 1 cm below the inion and 4 cm lateral; anode over the right deltoid; Soterix Medical 1×1 device) is delivered during the first 25 minutes of 45 to 60 minutes of computer-delivered language therapy targeting picture naming, auditory comprehension, reading and spelling, with a speech-language pathologist present throughout. Sessions may take place at a Johns Hopkins site or at home with a study team member present.
The primary comparison is change in WAB-R AQ from baseline (about 3 months post-stroke) to 6 months post-stroke between the treated early group and the untreated wait-list group. Secondary measures include naming of trained items, discourse (content units and syllables per content unit in picture description), functional communication (Communication Activities of Daily Living, Third Edition), emotional well-being (General Health Questionnaire), quality of life (Stroke and Aphasia Quality of Life Scale), and resting-state functional connectivity measured with functional near-infrared spectroscopy (fNIRS). Participants are followed to 12 months post-stroke.
As a pilot, the study is designed to show feasibility of the predict-then-intervene approach and to estimate effect sizes for a future fully powered, sham-controlled trial.
- Being tested
- Cathodal cerebellar transcranial direct current stimulation, Computerized language therapy
- Keywords
- transcranial direct current stimulation, tDCS, cerebellar stimulation, aphasia rehabilitation, precision rehabilitation
- Medical subject headings
- Aphasia, Stroke, Anomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cathodal cerebellar transcranial direct current stimulationDevice
Also called tDCS, Soterix Medical 1x1 tDCS
Cathode (saline-soaked sponge electrode) over the right cerebellum, 1 cm below the inion and 4 cm lateral; anode over the right deltoid. Constant current of 2 mA for 25 minutes, ramped up over the first 15 seconds, from a battery-powered Soterix Medical 1x1 stimulator with pre-programmed parameters. Delivered during the first 25 minutes of each language therapy session.
Computerized language therapyBehavioural
Also called Computer-delivered naming treatment
Computer-delivered language exercises on a tablet, targeting spoken and written picture naming, auditory comprehension, reading and spelling, 45 to 60 minutes per session, with difficulty adjusted to performance and a speech-language pathologist present. Each participant uses the same delivery platform for all sessions.
| Study group | Role | What they receive |
|---|---|---|
| Early intervention | Experimental | 15 sessions of cathodal right cerebellar transcranial direct current stimulation (tDCS; 2 mA, 25 minutes) during computerized language therapy (45 to 60 minutes per session, with a speech-language pathologist present), up to 5 sessions per week over about 3 to 5 weeks, beginning about 3 months post-stroke. Receives: Device: Cathodal cerebellar transcranial direct current stimulation; Behavioral: Computerized language therapy |
| Wait-list control (delayed intervention) | Other | Usual care, which may include outpatient speech-language therapy, from about 3 to 6 months post-stroke; then the same 15-session protocol of cathodal right cerebellar tDCS plus computerized language therapy, beginning about 6 months post-stroke. Receives: Device: Cathodal cerebellar transcranial direct current stimulation; Behavioral: Computerized language therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)
The WAB-R AQ is a composite measure of overall language impairment, with scores ranging from 0 to 100; higher scores indicate milder aphasia (better outcome). Change from baseline to 6 months post-stroke is compared between the early intervention group (after treatment) and the wait-list group (before treatment).
Measured: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Mean Absolute Error Between Predicted and Observed 12-Month Western Aphasia Battery-Revised Aphasia Quotient
Mean absolute difference, in WAB-R AQ points (scale 0 to 100), between the machine learning model's predicted 12-month Western Aphasia Battery-Revised Aphasia Quotient (generated from acute-phase data) and the observed 12-month score. Lower values indicate more accurate prediction.
Measured: 12 months post-stroke
Secondary outcomes (7)
Percentage of Treatment Items Produced Correctly
Percentage of items trained during treatment that are produced correctly, scored 0 to 100%; higher values indicate better performance.
Measured: During treatment, up to one week post final treatment session (about 4 to 6 weeks after treatment starts)
Change in Number of Content Units in Picture Description
Total number of content units (accurate, relevant pieces of information) produced when describing the Modern Cookie Theft picture and the Precarious Painter picture. Higher values indicate more informative discourse.
Measured: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in Syllables per Content Unit in Picture Description
Number of syllables produced per content unit in the same picture descriptions
Measured: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in Communication Activities of Daily Living, Third Edition (CADL-3) Total Score
The Communication Activities of Daily Living, Third Edition measures everyday functional communication in people with aphasia. Total raw score ranges from 0 to 100; higher scores indicate better functional communication.
Measured: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in General Health Questionnaire (GHQ) Total Score
The General Health Questionnaire (Goldberg and Hillier) measures psychological distress and emotional well-being. Items are rated using 0 to 3 Likert scale, giving a total score from 0 to 84; higher scores indicate greater psychological distress (worse outcome).
Measured: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in Stroke and Aphasia Quality of Life Scale (SAQOL-39) Mean Score
The Stroke and Aphasia Quality of Life Scale-39 measures health-related quality of life after stroke and aphasia. Mean score ranges from 1 to 5; higher scores indicate better quality of life.
Measured: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in Resting-State Functional Connectivity Between Cortical Language Regions and the Right Cerebellum
Resting-state functional connectivity (correlation coefficient of oxygenated hemoglobin signals) between cortical language regions and the right cerebellum, measured with functional near-infrared spectroscopy (fNIRS). Higher values indicate stronger connectivity.
Measured: Baseline (approximately 3 months post-stroke), 6 months, and 9 months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startNov 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Parallel groups
- Model description
- Pilot wait-list randomized controlled trial. The early intervention group is treated from about 3 months post-stroke; the wait-list group receives usual care until about 6 months post-stroke, then the same treatment. The primary comparison is at 6 months post-stroke, when the early group has been treated and the wait-list group has not.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Melissa D Stockbridge, PhD, CCC-SLP, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912242
- Sponsor's protocol ID
- IRB00562650
- Other IDs
- 2T32HD007414-31
- Acronym
- PART-CN
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared outside Johns Hopkins. Data collected in this study are coded protected health information under the approved protocol and consent. Aggregate results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Aphasia Recovery and Testing Cerebellar Neuromodulation (PART-CN): A Pilot Wait-List Randomized Trial of Cathodal Cerebellar Transcranial Direct Current Stimulation Plus Computerized Language Therapy in Stroke Survivors Predicted to Have Poor Language Recovery
- ClinicalTrials.gov ID
- NCT07912242
- Acronym / sponsor ID
- PART-CN / IRB00562650
- Keywords
- transcranial direct current stimulation, tDCS, cerebellar stimulation, aphasia rehabilitation, precision rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Nov 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 3 Nov 2026 (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.
This pilot study tests whether a mild form of brain stimulation to the cerebellum, combined with computer-based language therapy, helps people recover language after a stroke when a poor natural recovery is predicted.
People already taking part in a Johns Hopkins study of stroke and language recovery, whose early data suggest the aphasia is unlikely to resolve without treatment, are invited about 3 months after the stroke. Half begin 15 treatment sessions right away and half begin about 3 months later. Each session pairs 25 minutes of transcranial direct current stimulation (tDCS) over the right cerebellum with 45 to 60 minutes of language exercises, with a speech-language pathologist present.
The main question is whether language ability, measured with the Western Aphasia Battery-Revised Aphasia Quotient, improves more by 6 months after stroke in the group treated first than in the group still waiting. The study also checks how accurately a machine learning model, built from data collected in the first days after stroke, predicted each person's language ability 12 months after stroke.
Detailed description
About one third of people with aphasia after stroke respond poorly to language therapy, and current clinical tools cannot identify these individuals early, when recovery is steepest. This study pairs a recovery prediction model with a targeted treatment.
Aim 1: A machine learning model trained on acute-phase data from the parent longitudinal study (Johns Hopkins IRB NA_00042097; neuroimaging, cognitive-linguistic testing, demographics) predicts each participant's 12-month Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ). Participants predicted to remain below 93.8 (aphasia not expected to resolve) are eligible. Prediction accuracy is evaluated prospectively against observed 12-month scores (mean absolute error, correlation, and sensitivity, specificity, positive predictive value and F1 for the below-93.8 classification).
Aim 2: Eligible participants are randomized 1:1 to early intervention (treatment beginning about 3 months post-stroke) or wait-list control (usual care until about 6 months post-stroke, then the same treatment). Treatment is 15 sessions, up to 5 per week over about 3 to 5 weeks. In each session, cathodal tDCS (2 mA, 25 minutes; cathode over the right cerebellum, 1 cm below the inion and 4 cm lateral; anode over the right deltoid; Soterix Medical 1×1 device) is delivered during the first 25 minutes of 45 to 60 minutes of computer-delivered language therapy targeting picture naming, auditory comprehension, reading and spelling, with a speech-language pathologist present throughout. Sessions may take place at a Johns Hopkins site or at home with a study team member present.
The primary comparison is change in WAB-R AQ from baseline (about 3 months post-stroke) to 6 months post-stroke between the treated early group and the untreated wait-list group. Secondary measures include naming of trained items, discourse (content units and syllables per content unit in picture description), functional communication (Communication Activities of Daily Living, Third Edition), emotional well-being (General Health Questionnaire), quality of life (Stroke and Aphasia Quality of Life Scale), and resting-state functional connectivity measured with functional near-infrared spectroscopy (fNIRS). Participants are followed to 12 months post-stroke.
As a pilot, the study is designed to show feasibility of the predict-then-intervene approach and to estimate effect sizes for a future fully powered, sham-controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot wait-list randomized controlled trial. The early intervention group is treated from about 3 months post-stroke; the wait-list group receives usual care until about 6 months post-stroke, then the same treatment. The primary comparison is at 6 months post-stroke, when the early group has been treated and the wait-list group has not.
| Arm | Type | Receives |
|---|---|---|
| Early intervention | Experimental | Device: Cathodal cerebellar transcranial direct current stimulation, Behavioral: Computerized language therapy15 sessions of cathodal right cerebellar transcranial direct current stimulation (tDCS; 2 mA, 25 minutes) during computerized language therapy (45 to 60 minutes per session, with a speech-language pathologist present), up to 5 sessions per week over about 3 to 5 weeks, beginning about 3 months post-stroke. |
| Wait-list control (delayed intervention) | Other | Device: Cathodal cerebellar transcranial direct current stimulation, Behavioral: Computerized language therapyUsual care, which may include outpatient speech-language therapy, from about 3 to 6 months post-stroke; then the same 15-session protocol of cathodal right cerebellar tDCS plus computerized language therapy, beginning about 6 months post-stroke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Enrolled in the Johns Hopkins longitudinal stroke and aphasia study (IRB NA_00042097)
- Consented to future contact for research studies
- Predicted to have poor language recovery from acute-phase data, defined as a predicted Western Aphasia Battery-Revised Aphasia Quotient below 93.8 at 12 months post-stroke
- Ischemic left hemisphere stroke
- Aphasia with naming impairment on the Western Aphasia Battery-Revised
Key exclusion criteria (9 listed)
- Lesion in the right cerebellum
- Previous neurological disorder other than stroke affecting the brain, or any neurodegenerative or psychiatric disorder
- Seizures during the previous 6 months
- Uncorrected visual or hearing loss by self-report
- Use of medications that lower the seizure threshold (e.g., methylphenidate)
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 |
|---|---|---|
| Cathodal cerebellar transcranial direct current stimulationAlso: tDCS, Soterix Medical 1x1 tDCSCathode (saline-soaked sponge electrode) over the right cerebellum, 1 cm below the inion and 4 cm lateral; anode over the right deltoid. Constant current of 2 mA for 25 minutes, ramped up over the first 15 seconds, from a battery-powered Soterix Medical 1x1 stimulator with pre-programmed parameters. Delivered during the first 25 minutes of each language therapy session. | Device | Early intervention, Wait-list control (delayed intervention) |
| Computerized language therapyAlso: Computer-delivered naming treatmentComputer-delivered language exercises on a tablet, targeting spoken and written picture naming, auditory comprehension, reading and spelling, 45 to 60 minutes per session, with difficulty adjusted to performance and a speech-language pathologist present. Each participant uses the same delivery platform for all sessions. | Behavioural | Early intervention, Wait-list control (delayed intervention) |
Primary outcome
Change in Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)
Time frame: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
The WAB-R AQ is a composite measure of overall language impairment, with scores ranging from 0 to 100; higher scores indicate milder aphasia (better outcome). Change from baseline to 6 months post-stroke is compared between the early intervention group (after treatment) and the wait-list group (before treatment).
Mean Absolute Error Between Predicted and Observed 12-Month Western Aphasia Battery-Revised Aphasia Quotient
Time frame: 12 months post-stroke
Mean absolute difference, in WAB-R AQ points (scale 0 to 100), between the machine learning model's predicted 12-month Western Aphasia Battery-Revised Aphasia Quotient (generated from acute-phase data) and the observed 12-month score. Lower values indicate more accurate prediction.
7 secondary outcomes
Percentage of Treatment Items Produced Correctly
Time frame: During treatment, up to one week post final treatment session (about 4 to 6 weeks after treatment starts)
Change in Number of Content Units in Picture Description
Time frame: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in Syllables per Content Unit in Picture Description
Time frame: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in Communication Activities of Daily Living, Third Edition (CADL-3) Total Score
Time frame: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in General Health Questionnaire (GHQ) Total Score
Time frame: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in Stroke and Aphasia Quality of Life Scale (SAQOL-39) Mean Score
Time frame: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in Resting-State Functional Connectivity Between Cortical Language Regions and the Right Cerebellum
Time frame: Baseline (approximately 3 months post-stroke), 6 months, and 9 months post-stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside Johns Hopkins. Data collected in this study are coded protected health information under the approved protocol and consent. Aggregate results will be published.
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Enrolling by invitation
Effects of Semantic Context on Criterion-learning Naming Treatment in Aphasia
Aphasia
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.
Melissa D Stockbridge, PhD, CCC-SLP principal investigator
Johns Hopkins 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 Cathodal cerebellar transcranial direct current stimulation and Computerized language therapy in people with Aphasia and Stroke, run by Johns Hopkins University 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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 3 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manuel J Marte, PhD, CCC-SLP (845-598-6911, mmarte1@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) (time frame: Baseline (approximately 3 months post-stroke) and 6 months post-stroke). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.