Multiple SclerosistSCS-MSNCT07152145
Pilot Study of tSCS for Improving Upper Limb Function in People With Multiple Sclerosis
A study testing Active stimulation tSCS and Occupational/Upper Limb Rehabilitation Therapy in people with Multiple Sclerosis, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The goal of this clinical trial is to evaluate whether non-invasive spinal cord neuromodulation with the SCONE™ device can improve upper limb function in people with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Active stimulation tSCS and Occupational/Upper Limb Rehabilitation Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2025to Dec 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years.
- Diagnosis of Multiple Sclerosis (according to revised McDonald criteria).
- Upper limb dysfunction (9-Hole Peg Test score ≥ 20% slower than normative values).
- Stable disease-modifying treatment for ≥ 6 months before enrollment.
- Expanded Disability Status Scale (EDSS) score between 3.0 and 6.5.
- Ability to provide informed consent.
Who cannot join
- Relapse or corticosteroid treatment within the last 3 months.
- Severe spasticity of the upper limb (Modified Ashworth Scale > 3).
- Implanted electrical devices (pacemaker, spinal cord stimulator).
- Epilepsy or uncontrolled seizures.
- Severe psychiatric disorders or cognitive impairment interfering with study procedures.
- Pregnant or breastfeeding women.
- Participation in another interventional clinical trial within the last 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital del Mar
Barcelona, 08003
Pablo Villoslada, MD, PhD, +34933160455, pvilloslada@researchmar.net
Silvia Susin, MD, ssusin@researchmar.net
About this study
Official title: Transcutaneous Electrical Spinal Stimulation (tSCS) for Improving Upper Limb Function in People With MS
The goal of this clinical trial is to evaluate whether non-invasive spinal cord neuromodulation with the SCONE™ device can improve upper limb function in people with multiple sclerosis. The study will investigate if combining SCONE™ therapy with rehabilitation exercises leads to improvements in arm and hand movement, and whether the therapy is safe and well tolerated in this patient population. Participants will receive non-invasive spinal cord stimulation with the SCONE™ device and perform rehabilitation exercises specifically focused on the upper limb.
Read the detailed description
This is a pilot, randomized, placebo-controlled study designed to evaluate the efficacy and safety of transcutaneous spinal cord stimulation (tSCS) in improving upper limb function in patients with Multiple Sclerosis (MS).
tSCS is a non-invasive neuromodulation technique that delivers low-intensity electrical impulses through the skin to specific spinal segments. This external stimulation aims to enhance spinal excitability and restore communication between the brain and spinal circuits affected by MS. Previous research in spinal cord injury has demonstrated functional improvements in motor performance with tSCS, suggesting its potential benefit in MS-related disability.
In this study, participants with clinically confirmed MS and upper limb impairment will first undergo a 6-week period of standard occupational therapy. After this run-in phase, they will be randomly assigned in a 1:1 ratio to receive either active tSCS or sham stimulation for an additional 6 weeks, while continuing occupational therapy. The intervention will be delivered at the rehabilitation center of Hospital de la Esperanza, in a seated position, using surface electrodes placed at the posterior cervical region. Sessions will last approximately 30 minutes, three times per week (preferably Monday, Wednesday, and Friday).
The sham condition will mimic the procedure using the same equipment and electrode placement but without delivering effective stimulation. After completion of the blinded phase, participants originally randomized to sham will be offered the opportunity to receive active tSCS in an open-label extension.
The primary efficacy endpoint is improvement in upper limb function, assessed by the Nine-Hole Peg Test (9HPT). Secondary endpoints include the Action Research Arm Test (ARAT), patient-reported outcomes (NeuroQOL - Upper Extremity Function, Modified Fatigue Impact Scale [MFIS], and Global Impression of Change [GIC]), and clinical safety measures.
tSCS is generally safe and well-tolerated. Reported side effects are typically mild and transient, including tingling, skin irritation, or muscle discomfort. Participants will be monitored throughout the study, and adverse events will be recorded.
This pilot trial will provide preliminary data on the clinical utility of tSCS in MS and inform the design of larger randomized controlled trials.
- Conditions
- Multiple Sclerosis
- Being tested
- Active stimulation tSCS, Sham: stimulations using a non-active electric stimulation, Occupational/Upper Limb Rehabilitation Therapy
- Keywords
- Spinal Cord Neuromodulation, Non-invasive neuromodulation, Upper limb function, Neurorehabilitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active stimulation tSCSDevice
Active transcutaneous spinal cord stimulation (tSCS) delivered with the SCONE™ device. Electrical currents are applied non-invasively through surface electrodes placed on the skin over the spine. Sessions are combined with standardized upper limb rehabilitation therapy. Participants receive stimulation twice per week for 12 weeks.
Sham: stimulations using a non-active electric stimulationDevice
Sham stimulation delivered with the SCONE™ device, using identical setup and procedures as the active intervention but without effective current. This procedure is designed to mimic the sensation and experience of active stimulation while delivering no therapeutic neuromodulation. Participants also perform standardized upper limb rehabilitation therapy twice per week for 12 weeks.Transcutaneous Spinal Cord Stimulation (tSCS) - Sham (SCONE™)
Occupational/Upper Limb Rehabilitation TherapyBehavioural
Standardized occupational therapy program focused on upper limb function. Sessions are delivered in combination with either active or sham transcutaneous spinal cord stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Active tSCS + Rehabilitation | Experimental | Participants will receive active transcutaneous spinal cord stimulation (tSCS) using the SCONE™ device, combined with conventional upper limb rehabilitation therapy. Receives: Device: Active stimulation tSCS; Behavioral: Occupational/Upper Limb Rehabilitation Therapy |
| Sham tSCS + Rehabilitation | Sham comparator | Participants will receive sham stimulation using the SCONE™ device without active current, combined with conventional upper limb rehabilitation therapy. The setup will be identical to the active intervention to maintain blinding. Receives: Device: Sham: stimulations using a non-active electric stimulation; Behavioral: Occupational/Upper Limb Rehabilitation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper Limb Function (9-Hole Peg Test)
The 9-Hole Peg Test (9HPT) is a validated quantitative measure of upper extremity function. Participants are timed while placing and removing nine pegs into holes on a board as quickly as possible. Performance is recorded as time to completion. Change from baseline will be compared between active and sham groups.
Measured: Baseline and Week 12
Secondary outcomes (6)
Change in Hand Grip Strength (Dynamometry)
Grip strength will be measured using a calibrated hand dynamometer. The mean of three trials per hand will be recorded and analyzed as change from baseline.
Measured: Baseline and Week 12
Change in Quality of Life (EQ-5D-5L)
Patient-reported outcome measuring five domains of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Change from baseline will be assessed.
Measured: Baseline and Week 12
Change in Fatigue (Modified Fatigue Impact Scale - MFIS)
Self-reported questionnaire measuring the impact of fatigue on physical, cognitive, and psychosocial functioning. Change from baseline will be analyzed.
Measured: Baseline and Week 12
Change in Manual Dexterity (Box and Block Test)
The Box and Block Test measures gross manual dexterity by counting the number of blocks moved from one compartment to another in 60 seconds. Change from baseline will be assessed
Measured: Baseline and Week 12
Patient-Reported Upper Limb Function (Multiple Sclerosis Impact Scale - MSIS-29, upper limb subitems)
Patient-reported outcome measure assessing the perceived impact of MS on physical function, with specific focus on upper limb-related items. Higher scores indicate greater impact. Change from baseline will be compared.
Measured: Baseline and Week 12
Safety and Tolerability
Number and severity of adverse events related to the device or therapy will be recorded throughout the study. Tolerability will be assessed via patient-reported discomfort during stimulation.
Measured: Baseline through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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 Multiple SclerosisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PAblo Villoslada, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152145
- Sponsor's protocol ID
- tSCS-MS-01
- Acronym
- tSCS-MS
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in future publications will be shared. This will include baseline characteristics, efficacy outcomes, and safety data.
Publications
Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.
PubMed 29877852Moritz C, Field-Fote EC, Tefertiller C, van Nes I, Trumbower R, Kalsi-Ryan S, Purcell M, Janssen TWJ, Krassioukov A, Morse LR, Zhao KD, Guest J, Marino RJ, Murray LM, Wecht JM, Rieger M, Pradarelli J, Turner A, D'Amico J, Squair JW, Courtine G. Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial. Nat Med. 2024 May;30(5):1276-1283. doi: 10.1038/s41591-024-02940-9. Epub 2024 May 20.
PubMed 38769431Tu YH, Stiles ML, Allen LV Jr, Olsen KM, Barton CI, Greenwood RB. Stability of amoxicillin trihydrate-potassium clavulanate in original containers and unit dose oral syringes. Am J Hosp Pharm. 1988 May;45(5):1092-9.
PubMed 3400652Barss TS, Parhizi B, Porter J, Mushahwar VK. Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. J Clin Med. 2022 Jan 27;11(3):639. doi: 10.3390/jcm11030639.
PubMed 35160091Waltz JM, Andreesen WH, Hunt DP. Spinal cord stimulation and motor disorders. Pacing Clin Electrophysiol. 1987 Jan;10(1 Pt 2):180-204. doi: 10.1111/j.1540-8159.1987.tb05947.x.
PubMed 2436177Wallin MT, Culpepper WJ, Campbell JD, Nelson LM, Langer-Gould A, Marrie RA, Cutter GR, Kaye WE, Wagner L, Tremlett H, Buka SL, Dilokthornsakul P, Topol B, Chen LH, LaRocca NG; US Multiple Sclerosis Prevalence Workgroup. The prevalence of MS in the United States: A population-based estimate using health claims data. Neurology. 2019 Mar 5;92(10):e1029-e1040. doi: 10.1212/WNL.0000000000007035. Epub 2019 Feb 15.
PubMed 30770430
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Spinal Stimulation (tSCS) for Improving Upper Limb Function in People With MS
- ClinicalTrials.gov ID
- NCT07152145
- Acronym / sponsor ID
- tSCS-MS / tSCS-MS-01
- Conditions
- Multiple Sclerosis
- Keywords
- Spinal Cord Neuromodulation, Non-invasive neuromodulation, Upper limb function, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Sep 2025 (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 goal of this clinical trial is to evaluate whether non-invasive spinal cord neuromodulation with the SCONE™ device can improve upper limb function in people with multiple sclerosis. The study will investigate if combining SCONE™ therapy with rehabilitation exercises leads to improvements in arm and hand movement, and whether the therapy is safe and well tolerated in this patient population. Participants will receive non-invasive spinal cord stimulation with the SCONE™ device and perform rehabilitation exercises specifically focused on the upper limb.
Detailed description
This is a pilot, randomized, placebo-controlled study designed to evaluate the efficacy and safety of transcutaneous spinal cord stimulation (tSCS) in improving upper limb function in patients with Multiple Sclerosis (MS).
tSCS is a non-invasive neuromodulation technique that delivers low-intensity electrical impulses through the skin to specific spinal segments. This external stimulation aims to enhance spinal excitability and restore communication between the brain and spinal circuits affected by MS. Previous research in spinal cord injury has demonstrated functional improvements in motor performance with tSCS, suggesting its potential benefit in MS-related disability.
In this study, participants with clinically confirmed MS and upper limb impairment will first undergo a 6-week period of standard occupational therapy. After this run-in phase, they will be randomly assigned in a 1:1 ratio to receive either active tSCS or sham stimulation for an additional 6 weeks, while continuing occupational therapy. The intervention will be delivered at the rehabilitation center of Hospital de la Esperanza, in a seated position, using surface electrodes placed at the posterior cervical region. Sessions will last approximately 30 minutes, three times per week (preferably Monday, Wednesday, and Friday).
The sham condition will mimic the procedure using the same equipment and electrode placement but without delivering effective stimulation. After completion of the blinded phase, participants originally randomized to sham will be offered the opportunity to receive active tSCS in an open-label extension.
The primary efficacy endpoint is improvement in upper limb function, assessed by the Nine-Hole Peg Test (9HPT). Secondary endpoints include the Action Research Arm Test (ARAT), patient-reported outcomes (NeuroQOL - Upper Extremity Function, Modified Fatigue Impact Scale [MFIS], and Global Impression of Change [GIC]), and clinical safety measures.
tSCS is generally safe and well-tolerated. Reported side effects are typically mild and transient, including tingling, skin irritation, or muscle discomfort. Participants will be monitored throughout the study, and adverse events will be recorded.
This pilot trial will provide preliminary data on the clinical utility of tSCS in MS and inform the design of larger randomized controlled trials.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tSCS + Rehabilitation | Experimental | Device: Active stimulation tSCS, Behavioral: Occupational/Upper Limb Rehabilitation TherapyParticipants will receive active transcutaneous spinal cord stimulation (tSCS) using the SCONE™ device, combined with conventional upper limb rehabilitation therapy. |
| Sham tSCS + Rehabilitation | Sham comparator | Device: Sham: stimulations using a non-active electric stimulation, Behavioral: Occupational/Upper Limb Rehabilitation TherapyParticipants will receive sham stimulation using the SCONE™ device without active current, combined with conventional upper limb rehabilitation therapy. The setup will be identical to the active intervention to maintain blinding. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 70 years.
- Diagnosis of Multiple Sclerosis (according to revised McDonald criteria).
- Upper limb dysfunction (9-Hole Peg Test score ≥ 20% slower than normative values).
- Stable disease-modifying treatment for ≥ 6 months before enrollment.
- Expanded Disability Status Scale (EDSS) score between 3.0 and 6.5.
Key exclusion criteria (7 listed)
- Relapse or corticosteroid treatment within the last 3 months.
- Severe spasticity of the upper limb (Modified Ashworth Scale > 3).
- Implanted electrical devices (pacemaker, spinal cord stimulator).
- Epilepsy or uncontrolled seizures.
- Severe psychiatric disorders or cognitive impairment interfering with study procedures.
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 |
|---|---|---|
| Active stimulation tSCSActive transcutaneous spinal cord stimulation (tSCS) delivered with the SCONE™ device. Electrical currents are applied non-invasively through surface electrodes placed on the skin over the spine. Sessions are combined with standardized upper limb rehabilitation therapy. Participants receive stimulation twice per week for 12 weeks. | Device | Active tSCS + Rehabilitation |
| Sham: stimulations using a non-active electric stimulationSham stimulation delivered with the SCONE™ device, using identical setup and procedures as the active intervention but without effective current. This procedure is designed to mimic the sensation and experience of active stimulation while delivering no therapeutic neuromodulation. Participants also perform standardized upper limb rehabilitation therapy twice per week for 12 weeks.Transcutaneous Spinal Cord Stimulation (tSCS) - Sham (SCONE™) | Device | Sham tSCS + Rehabilitation |
| Occupational/Upper Limb Rehabilitation TherapyStandardized occupational therapy program focused on upper limb function. Sessions are delivered in combination with either active or sham transcutaneous spinal cord stimulation. | Behavioural | Active tSCS + Rehabilitation, Sham tSCS + Rehabilitation |
Primary outcome
Change in Upper Limb Function (9-Hole Peg Test)
Time frame: Baseline and Week 12
The 9-Hole Peg Test (9HPT) is a validated quantitative measure of upper extremity function. Participants are timed while placing and removing nine pegs into holes on a board as quickly as possible. Performance is recorded as time to completion. Change from baseline will be compared between active and sham groups.
6 secondary outcomes
Change in Hand Grip Strength (Dynamometry)
Time frame: Baseline and Week 12
Change in Quality of Life (EQ-5D-5L)
Time frame: Baseline and Week 12
Change in Fatigue (Modified Fatigue Impact Scale - MFIS)
Time frame: Baseline and Week 12
Change in Manual Dexterity (Box and Block Test)
Time frame: Baseline and Week 12
Patient-Reported Upper Limb Function (Multiple Sclerosis Impact Scale - MSIS-29, upper limb subitems)
Time frame: Baseline and Week 12
Safety and Tolerability
Time frame: Baseline through Week 12
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 Sep 2025.
- Background: PubMed 29877852Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.
- Background: PubMed 38769431Moritz C, Field-Fote EC, Tefertiller C, van Nes I, Trumbower R, Kalsi-Ryan S, Purcell M, Janssen TWJ, Krassioukov A, Morse LR, Zhao KD, Guest J, Marino RJ, Murray LM, Wecht JM, Rieger M, Pradarelli J, Turner A, D'Amico J, Squair JW, Courtine G. Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial. Nat Med. 2024 May;30(5):1276-1283. doi: 10.1038/s41591-024-02940-9. Epub 2024 May 20.
- Background: PubMed 3400652Tu YH, Stiles ML, Allen LV Jr, Olsen KM, Barton CI, Greenwood RB. Stability of amoxicillin trihydrate-potassium clavulanate in original containers and unit dose oral syringes. Am J Hosp Pharm. 1988 May;45(5):1092-9.
- Background: PubMed 35160091Barss TS, Parhizi B, Porter J, Mushahwar VK. Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. J Clin Med. 2022 Jan 27;11(3):639. doi: 10.3390/jcm11030639.
- Background: PubMed 2436177Waltz JM, Andreesen WH, Hunt DP. Spinal cord stimulation and motor disorders. Pacing Clin Electrophysiol. 1987 Jan;10(1 Pt 2):180-204. doi: 10.1111/j.1540-8159.1987.tb05947.x.
- Background: PubMed 30770430Wallin MT, Culpepper WJ, Campbell JD, Nelson LM, Langer-Gould A, Marrie RA, Cutter GR, Kaye WE, Wagner L, Tremlett H, Buka SL, Dilokthornsakul P, Topol B, Chen LH, LaRocca NG; US Multiple Sclerosis Prevalence Workgroup. The prevalence of MS in the United States: A population-based estimate using health claims data. Neurology. 2019 Mar 5;92(10):e1029-e1040. doi: 10.1212/WNL.0000000000007035. Epub 2019 Feb 15.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in future publications will be shared. This will include baseline characteristics, efficacy outcomes, and safety data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active stimulation tSCS and Occupational/Upper Limb Rehabilitation Therapy in people with Multiple Sclerosis, run by Parc de Salut Mar at 1 site in Spain.
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 6 inclusion and 7 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 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Upper Limb Function (9-Hole Peg Test) (time frame: Baseline and Week 12). 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 NCT07152145, 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 3 Sep 2025.