Spasticity, MuscleNCT04076878
Effects of Using the Electrodress Mollii on Spasticity
A study testing Mollii in people with Spasticity, Muscle and Stroke, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
Spasticity is a common manifestation of lesions of central motor pathways, such as after stroke, traumatic brain or spinal cord injury and in cerebral palsy and is associated with increased impairments and disabilities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity, Muscle, Stroke, Electric Stimulation Therapy
- What is being tested?
- Mollii
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- 15 Aug 2017to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants had
- suffered a stroke > 12 months earlier
- were living with hemiplegia affecting the right or the left side of the body including both upper and lower extremity function
- were able to walk with assistance or independently according to the Functional Ambulatory Categories (Holden 1984) with a score of 2-5
- activity in upper extremity was limited according to the Action Research Arm test (ARAT) (Nordin 2014) but could perform a grasp and grip movement
- were > 17 years old, able to understand instructions as well as written and oral study information and could express informed consent
Who cannot join
- no detected neural component exceeding the cut off for spasticity according to the Neuroflexor (> 3. 4 Newton) in the wrist flexors
- contractures not compatible with performing the Neurofexor test or walking
- any other disorder with an impact on sensorimotor function
- any other severe concomitant disease (such as cancer, cardiovascular, inflammatory or psychiatric disease), uncontrolled epilepsy or blood pressure, major surgery during the last year, any implanted medical devices
- pregnancy
- BMI>35
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Rehabilitation Medicine, Danderyd Hospital
Danderyd, Stockholm County, SE18288
About this study
Official title: Effects of Using the Electrodress Mollii to Reduce Spasticity and Enhance Functioning After Stroke.
Spasticity is a common manifestation of lesions of central motor pathways, such as after stroke, traumatic brain or spinal cord injury and in cerebral palsy and is associated with increased impairments and disabilities. Spasticity may be associated with pain and contractures, caused by muscle weakness, reduced muscle length and volume that add to the disability.Treatments of spasticity comprise physical therapy, pharmacological agents and surgical treatment. Recently, a systematic review concluded that transcutaneous, electric nerve stimulation may have beneficial effects on spasticity and activity performance after stroke, which lends support to the new treatment method Mollii, which will be evaluated in this study.The Mollii suit provides electric stimulation through multiple electrodes places in a tight fitting suit. This study relates to the clinical trials performed at the University department of rehabilitation medicine at Danderyd Hospital in Stockholm and comprises an initial study of effects on spasticity ("Mechanical substudy") and a following, exploratory treatment trial ("Clinical substudy") in patients with spasticity after stroke.
Read the detailed description
Spasticity is a common manifestation of lesions of central motor pathways, such as after stroke, traumatic brain or spinal cord injury and in cerebral palsy and is associated with increased impairments and disabilities. Spasticity may be associated with pain and contractures, caused by muscle weakness, reduced muscle length and volume that add to the disability.Treatments of spasticity comprise physical therapy, pharmacological agents and surgical treatment. Recently, a systematic review concluded that transcutaneous, electric nerve stimulation may have beneficial effects on spasticity and activity performance after stroke, which lends support to the new treatment method Mollii, which will be evaluated in this study.The Mollii method has been developed by Inervetions, which is a small Swedish med-tech company, and represents an innovative approach for non-invasive electro-stimulation to reduce spasticity and improve motor function. The theoretical background of this treatment method primarily refers to the concept of reciprocal inhibition, i.e. that sensory input from a muscle may inhibit the activation of an antagonistic muscle. Thus, the application of Mollii aims at stimulating a muscle, e.g. the anterior tibial muscle of the lower leg in order to reduce reflex mediated over-activity, i.e. spasticity, in calf muscles by inducing reciprocal inhibition.
- Conditions
- Spasticity, Muscle, Stroke, Electric Stimulation Therapy
- Being tested
- Mollii
- Keywords
- Spasticity, Stroke, Functioning, Disability, Intervention, electrical stimulation therapy
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MolliiDevice
The Mollii method is provided in a tight fitting, whole body suit with multiple electrodes that can be set individually. The Mollii method uses low frequencies and low intensities that evokes sensory input but does not directly elicit muscle contractions. The theoretical background of this treatment method primarily refers to the concept of reciprocal inhibition, i.e. that sensory input from a muscle may inhibit the activation of an antagonistic muscle through the activation of the disynaptic reciprocal Ia inhibitory pathway.
| Study group | Role | What they receive |
|---|---|---|
| Intervention in a Mechanism and a Clinical substudy | Experimental | Mechanism substudy: 3 trial sessions ( electrodes set to 1) 20 Hz, 2) 30 Hz, 3) 0 Hz (placebo). Patients and datacollectors were blinded in terms of the randomised order of the treatment at each of the 3 trial sessions ( electrodes set to 1) 20 Hz, 2) 30 Hz, 3) 0 Hz (placebo).
Clinical substudy: Use of the fitted and individually set body suit, Mollii, in the home setting for 6 weeks Receives: Device: Mollii |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanism substudy and Clinical substudy: NeuroFlexor
Measure related to spasticity: The Neuroflexor device comprises a portable computer-controlled step motor system with a lever arm that generates constant velocity movements of the wrist or ankle. The passive resistive force of the wrist or ankle is recorded by a force transducer. The force is then analyzed off-line and the total resistance is separated into mechanical and a neural components using a neuro-biomechanical computerized model. NeuroFlexor neural component reflecting stretch reflex mediated resistance, represents the main outcome. The NeuroFlexor hand (used in mechanism and clinical substudy) and foot module (used in mechansim substudy only) is a valid method that quantifies and distinguishes the genuine spasticity and the mechanical contributions (viscoelastic and soft tissue components) of the resistance opposing a passive stretch.
Measured: Mechanism study: To assess change, NeuroFlexor data is recorded before, during and 10 minutes after treatment at each session. Clinical study: To assess change Neuroflexor data is collected before and after the 6 week intervention.
Secondary outcomes (15)
Mechanism substudy: Surface electromyography
Measure related to spasticity: Surface electromyography (sEMG) signal of spastic muscles in the upper and lower limb (flexor carpi radialis, medial gastrocnemius and soleus muscles).
Measured: To assess change sEMG are assessed before and after 60 min of treatment at each session.
Mechanism substudy: Modified Ashworth scale:
Clinical assessment of spasticity on a 5 point scale ranging from 0= no spasticity to 5= rigidity
Measured: Before and after 60 min of treatment at each session to assess change
Mechanism substudy: Semi structured interview
To assess perceived effects of each intervention
Measured: During the 60 min of treatment at each session
Clinical substudy: the Fugl-Meyer scale
Clinical assessment of motor sensory function of the upper (min 0 p and max 126p) and lower extremity (min 0 p and max 86p). Max point indicates no detected impairment.
Measured: Before and after the 6 week intervention to assess change
Clinical substudy: Modified Ashworth scale
Clinical assessment of spasticity on a 5 point scale ranging from 0= no spasticity to 5= rigidity
Measured: Before and after the 6 week intervention to assess change
Clinical substudy: Barthel Index
Assessment of self-care and mobility (min 0 p and max 100p). Max point indicates independence
Measured: Before and after the 6 week intervention to assess change
Clinical substudy: Berg balance scale
Clinical assessment of balance (max 56p). Max point indicate no limitations in balance.
Measured: Before and after the 6 week intervention to assess change
Clinical substudy: Montreal Cognitive Assessment
Assessment of cognitive function (min 0 p and max 30p). Max point indicate no impairment.
Measured: Before and after the 6 week intervention to assess change
Clinical substudy: Action Research Arm Test
Clinical assessment of activity in upper extremity (max 57 p). Max point indicate no limitation.
Measured: Before and after the 6 week intervention to assess change
Clinical substudy: A digital hand dynamometer
Clinical assessment of grip strength in kilograms.
Measured: Before and after the 6 week intervention to assess change
Clinical substudy: 10 meter walk test
Clinical assessment of walking speed (m/s)
Measured: Before and after the 6 week intervention to assess change
Clinical substudy: 6 min walk test
Clinical assessment of walking endurance (meters)
Measured: Before and after the 6 week intervention to assess change
Clinical substudy: Functional Ambulation Category
Assessment of indedence in walking (min 0 p and max 5p) Max point indicate independence
Measured: Before and after the 6 week intervention to assess change
Clinical substudy: Stroke Impact Scale
Self-perceived functioning and disability (min 0 p and max 100p/item). Max point indicate no perceived disability.
Measured: Before and after the 6 week intervention to assess change
Clinical substudy: Weekly semistructured telephone interview
To assess compliance, perceived effects and adverse events.
Measured: Weekly during the 6 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start15 Aug 2017
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spasticity, MuscleStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Mechanism substudy: explorative single group design with three different stimulation paradigms provided to all participants by double blinded randomisation. Clinical substudy: explorative single group design.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Palmcrantz, Danderyd Hospital
- Investigators
- Susanne Palmcrantz, PhD, Principal investigator, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076878
- Sponsor's protocol ID
- Mollii for spasticity
- Status last verified
- Aug 2019
- First submitted
- 31 Jul 2019
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaverth J, Eliasson AC, Kullander K, Borg J, Lindberg PG, Forssberg H. Sensitivity of the NeuroFlexor method to measure change in spasticity after treatment with botulinum toxin A in wrist and finger muscles. J Rehabil Med. 2014 Jul;46(7):629-34. doi: 10.2340/16501977-1824.
PubMed 24850135Gaverth J, Sandgren M, Lindberg PG, Forssberg H, Eliasson AC. Test-retest and inter-rater reliability of a method to measure wrist and finger spasticity. J Rehabil Med. 2013 Jul;45(7):630-6. doi: 10.2340/16501977-1160.
PubMed 23695917Lindberg PG, Gaverth J, Islam M, Fagergren A, Borg J, Forssberg H. Validation of a new biomechanical model to measure muscle tone in spastic muscles. Neurorehabil Neural Repair. 2011 Sep;25(7):617-25. doi: 10.1177/1545968311403494. Epub 2011 Apr 13.
PubMed 21490269Pennati GV, Bergling H, Carment L, Borg J, Lindberg PG, Palmcrantz S. Effects of 60 Min Electrostimulation With the EXOPULSE Mollii Suit on Objective Signs of Spasticity. Front Neurol. 2021 Oct 15;12:706610. doi: 10.3389/fneur.2021.706610. eCollection 2021.
PubMed 34721255Palmcrantz S, Pennati GV, Bergling H, Borg J. Feasibility and potential effects of using the electro-dress Mollii on spasticity and functioning in chronic stroke. J Neuroeng Rehabil. 2020 Aug 10;17(1):109. doi: 10.1186/s12984-020-00740-z.
PubMed 32778118
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Using the Electrodress Mollii to Reduce Spasticity and Enhance Functioning After Stroke.
- ClinicalTrials.gov ID
- NCT04076878
- Acronym / sponsor ID
- Mollii for spasticity
- Conditions
- Spasticity, Muscle, Stroke, Electric Stimulation Therapy
- Keywords
- Spasticity, Stroke, Functioning, Disability, Intervention, electrical stimulation therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 3 Sep 2019 (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.
Spasticity is a common manifestation of lesions of central motor pathways, such as after stroke, traumatic brain or spinal cord injury and in cerebral palsy and is associated with increased impairments and disabilities. Spasticity may be associated with pain and contractures, caused by muscle weakness, reduced muscle length and volume that add to the disability.Treatments of spasticity comprise physical therapy, pharmacological agents and surgical treatment. Recently, a systematic review concluded that transcutaneous, electric nerve stimulation may have beneficial effects on spasticity and activity performance after stroke, which lends support to the new treatment method Mollii, which will be evaluated in this study.The Mollii suit provides electric stimulation through multiple electrodes places in a tight fitting suit. This study relates to the clinical trials performed at the University department of rehabilitation medicine at Danderyd Hospital in Stockholm and comprises an initial study of effects on spasticity ("Mechanical substudy") and a following, exploratory treatment trial ("Clinical substudy") in patients with spasticity after stroke.
Detailed description
Spasticity is a common manifestation of lesions of central motor pathways, such as after stroke, traumatic brain or spinal cord injury and in cerebral palsy and is associated with increased impairments and disabilities. Spasticity may be associated with pain and contractures, caused by muscle weakness, reduced muscle length and volume that add to the disability.Treatments of spasticity comprise physical therapy, pharmacological agents and surgical treatment. Recently, a systematic review concluded that transcutaneous, electric nerve stimulation may have beneficial effects on spasticity and activity performance after stroke, which lends support to the new treatment method Mollii, which will be evaluated in this study.The Mollii method has been developed by Inervetions, which is a small Swedish med-tech company, and represents an innovative approach for non-invasive electro-stimulation to reduce spasticity and improve motor function. The theoretical background of this treatment method primarily refers to the concept of reciprocal inhibition, i.e. that sensory input from a muscle may inhibit the activation of an antagonistic muscle. Thus, the application of Mollii aims at stimulating a muscle, e.g. the anterior tibial muscle of the lower leg in order to reduce reflex mediated over-activity, i.e. spasticity, in calf muscles by inducing reciprocal inhibition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mechanism substudy: explorative single group design with three different stimulation paradigms provided to all participants by double blinded randomisation. Clinical substudy: explorative single group design.
| Arm | Type | Receives |
|---|---|---|
| Intervention in a Mechanism and a Clinical substudy | Experimental | Device: MolliiMechanism substudy: 3 trial sessions ( electrodes set to 1) 20 Hz, 2) 30 Hz, 3) 0 Hz (placebo). Patients and datacollectors were blinded in terms of the randomised order of the treatment at each of the 3 trial sessions ( electrodes set to 1) 20 Hz, 2) 30 Hz, 3) 0 Hz (placebo). Clinical substudy: Use of the fitted and individually set body suit, Mollii, in the home setting for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eligible participants had
- suffered a stroke > 12 months earlier
- were living with hemiplegia affecting the right or the left side of the body including both upper and lower extremity function
- were able to walk with assistance or independently according to the Functional Ambulatory Categories (Holden 1984) with a score of 2-5
- activity in upper extremity was limited according to the Action Research Arm test (ARAT) (Nordin 2014) but could perform a grasp and grip movement
Key exclusion criteria (6 listed)
- no detected neural component exceeding the cut off for spasticity according to the Neuroflexor (> 3. 4 Newton) in the wrist flexors
- contractures not compatible with performing the Neurofexor test or walking
- any other disorder with an impact on sensorimotor function
- any other severe concomitant disease (such as cancer, cardiovascular, inflammatory or psychiatric disease), uncontrolled epilepsy or blood pressure, major surgery during the last year, any implanted medical devices
- pregnancy
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 |
|---|---|---|
| MolliiThe Mollii method is provided in a tight fitting, whole body suit with multiple electrodes that can be set individually. The Mollii method uses low frequencies and low intensities that evokes sensory input but does not directly elicit muscle contractions. The theoretical background of this treatment method primarily refers to the concept of reciprocal inhibition, i.e. that sensory input from a muscle may inhibit the activation of an antagonistic muscle through the activation of the disynaptic reciprocal Ia inhibitory pathway. | Device | Intervention in a Mechanism and a Clinical substudy |
Primary outcome
Mechanism substudy and Clinical substudy: NeuroFlexor
Time frame: Mechanism study: To assess change, NeuroFlexor data is recorded before, during and 10 minutes after treatment at each session. Clinical study: To assess change Neuroflexor data is collected before and after the 6 week intervention.
Measure related to spasticity: The Neuroflexor device comprises a portable computer-controlled step motor system with a lever arm that generates constant velocity movements of the wrist or ankle. The passive resistive force of the wrist or ankle is recorded by a force transducer. The force is then analyzed off-line and the total resistance is separated into mechanical and a neural components using a neuro-biomechanical computerized model. NeuroFlexor neural component reflecting stretch reflex mediated resistance, represents the main outcome. The NeuroFlexor hand (used in mechanism and clinical substudy) and foot module (used in mechansim substudy only) is a valid method that quantifies and distinguishes the genuine spasticity and the mechanical contributions (viscoelastic and soft tissue components) of the resistance opposing a passive stretch.
15 secondary outcomes
Mechanism substudy: Surface electromyography
Time frame: To assess change sEMG are assessed before and after 60 min of treatment at each session.
Mechanism substudy: Modified Ashworth scale:
Time frame: Before and after 60 min of treatment at each session to assess change
Mechanism substudy: Semi structured interview
Time frame: During the 60 min of treatment at each session
Clinical substudy: the Fugl-Meyer scale
Time frame: Before and after the 6 week intervention to assess change
Clinical substudy: Modified Ashworth scale
Time frame: Before and after the 6 week intervention to assess change
Clinical substudy: Barthel Index
Time frame: Before and after the 6 week intervention to assess change
Clinical substudy: Berg balance scale
Time frame: Before and after the 6 week intervention to assess change
Clinical substudy: Montreal Cognitive Assessment
Time frame: Before and after the 6 week intervention to assess change
Clinical substudy: Action Research Arm Test
Time frame: Before and after the 6 week intervention to assess change
Clinical substudy: A digital hand dynamometer
Time frame: Before and after the 6 week intervention to assess change
Clinical substudy: 10 meter walk test
Time frame: Before and after the 6 week intervention to assess change
Clinical substudy: 6 min walk test
Time frame: Before and after the 6 week intervention to assess change
Clinical substudy: Functional Ambulation Category
Time frame: Before and after the 6 week intervention to assess change
Clinical substudy: Stroke Impact Scale
Time frame: Before and after the 6 week intervention to assess change
Clinical substudy: Weekly semistructured telephone interview
Time frame: Weekly during the 6 week intervention
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 3 Sep 2019.
- Background: PubMed 24850135Gaverth J, Eliasson AC, Kullander K, Borg J, Lindberg PG, Forssberg H. Sensitivity of the NeuroFlexor method to measure change in spasticity after treatment with botulinum toxin A in wrist and finger muscles. J Rehabil Med. 2014 Jul;46(7):629-34. doi: 10.2340/16501977-1824.
- Background: PubMed 23695917Gaverth J, Sandgren M, Lindberg PG, Forssberg H, Eliasson AC. Test-retest and inter-rater reliability of a method to measure wrist and finger spasticity. J Rehabil Med. 2013 Jul;45(7):630-6. doi: 10.2340/16501977-1160.
- Background: PubMed 21490269Lindberg PG, Gaverth J, Islam M, Fagergren A, Borg J, Forssberg H. Validation of a new biomechanical model to measure muscle tone in spastic muscles. Neurorehabil Neural Repair. 2011 Sep;25(7):617-25. doi: 10.1177/1545968311403494. Epub 2011 Apr 13.
- Derived from this study: PubMed 34721255Pennati GV, Bergling H, Carment L, Borg J, Lindberg PG, Palmcrantz S. Effects of 60 Min Electrostimulation With the EXOPULSE Mollii Suit on Objective Signs of Spasticity. Front Neurol. 2021 Oct 15;12:706610. doi: 10.3389/fneur.2021.706610. eCollection 2021.
- Derived from this study: PubMed 32778118Palmcrantz S, Pennati GV, Bergling H, Borg J. Feasibility and potential effects of using the electro-dress Mollii on spasticity and functioning in chronic stroke. J Neuroeng Rehabil. 2020 Aug 10;17(1):109. doi: 10.1186/s12984-020-00740-z.
- 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.
Susanne Palmcrantz, PhD principal investigator
Danderyd Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mollii in people with Spasticity, Muscle and Stroke, run by Danderyd Hospital at 1 site in Sweden.
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 6 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 3 Sep 2019. 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 Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanism substudy and Clinical substudy: NeuroFlexor (time frame: Mechanism study: To assess change, NeuroFlexor data is recorded before, during and 10 minutes after treatment at each session. Clinical study: To assess change Neuroflexor data is collected before and after the 6 week intervention.). 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 NCT04076878, which also lists 5 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 2019; AzTrials last refreshed its copy on 6 Nov 2026.