StrokeNCT03508037

Therapy to Improve Reaching Movement in Upper Limb

A study testing Neuromodulation electroencephalographic signals and functional electrical stimulation based in people with Stroke and Impairment Upper Limb, run by Cajal Institute of the Spanish National Research Council at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke, Impairment Upper Limb
What is being tested?: Neuromodulation electroencephalographic signals and functional electrical stimulation based
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteSpain
Study dates: 12 Mar 2018to May 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

With response to Transcranial Magnetic Stimulation (TMS)
Cortical or sub-cortical stroke patients
With a score in the range of 22-44 on Fugl-Meyer scale or 2-4 on the Motor Assessment Scale
With visible cortical patterns registered by BCI
Subjects that tolerate electrical stimulation and that present a motor response
Subjects with cognitive ability to follow instructions and perform the indicated tasks

Who cannot join

Subjects with neurological injury prior to stroke or more than two events
Patients with implanted devices
Patients with severe motor paralysis
Patients with epilepsy
Patient with vision or hearing impairment

Trial locations and contacts

1 site in 1 country.

Oscar Herrero contact

+ 34 645 16 31 66

oscar.herrero@cajal.csic.es

Spain1 site, 1 recruiting

Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC)
Madrid, 28034
Carlos Gonzalez, +34 696993123, cgonzaalted@imserso.es
Recruiting

Other trials in Spain

About this study

Official title: Hybrid Robotic System and EEG Based on an Adaptative and Associative Assistance for Rehabilitation of Reaching Movements After Stroke

Strokes are caused by a bleed in the brain and can be life threatening. One common consequence is upper limb impairment. This causes stroke patients to be unable to use their arms and upper body to do simple tasks such as reaching or grasping. Currently, people with stroke undergo rehabilitation, which is usually done through a physical and occupational (daily living skills) therapies to improve their mobility (movement) with their upper limbs. However, this kind of treatment has limitations and often cannot help patients regain total mobility. There are alternative rehabilitation treatments that use new methods and technologies that may be able to help patients with stroke. Neuromodulaton therapies using brain-computer interfaces (BCI), which connects brain signals directly to a computer, have the potential to help patients. This type of therapy uses assistive devices such as electrical stimulation (electrical shocks or waves) and robots to help restore function to the areas affected by stroke. The aim of this study is to evaluate and the potential benefits that can be achieved by using assistive devices in rehabilitation sessions with stroke patients.

Conditions: Stroke, Impairment Upper Limb
Being tested: Neuromodulation electroencephalographic signals and functional electrical stimulation based
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neuromodulation electroencephalographic signals and functional electrical stimulation basedOther
Also called Neuromodulation
First, the subject performs twenty reaching movements without assistance with the damaged arm resting on a robot (ArmeoSpring), with the aim of finding the Contingent Negative Variation (CNV). Then, he or she executes five courses of twenty movements receiving functional electrical stimulation (FES), either at the moment in which he or she wishes to move (experimental group), or half a second before or after (control group).

Study groups in NCT03508037
Study group	Role	What they receive
Experimental group	Experimental	The subject receives the Functional Electrical Stimulation (FES) when he or she has the intention to move. It is obtained through electroencephalography. Receives: Other: Neuromodulation electroencephalographic signals and functional electrical stimulation based
Control group	Active comparator	The subject receives the Functional Electrical Stimulation (FES) after o before (0.5 seconds) when he or she has the intention to move. It is obtained through electroencephalography. Receives: Other: Neuromodulation electroencephalographic signals and functional electrical stimulation based

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in muscular balance's of upper limb
The function of muscle strength testing is to evaluate the complaint of weakness, often when there is a suspected neurologic disease. It is an integral part of the neurologic exam, especially for patients with stroke, brain injury, and others neurologic problems.
The most commonly accepted method of evaluating muscle strength is the Medical Research Council Manual Muscle Testing scale. This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly:
0 No muscle activation
1. Trace muscle activation, such as a twitch, without achieving full range of motion
2. Muscle activation with gravity eliminated, achieving full range of motion
3. Muscle activation against gravity, full range of motion
4. Muscle activation against some resistance, full range of motion
5. Muscle activation against examiner's full resistance, full range of motion
Measured: One week before the intervention. One week after the intervention. One month after the intervention. (The duration of the intervention is three weeks).
Changes in modified scale of Answorth
Modified Ashworth Scale tests resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 6 choices. A score of 1 indicates no resistance, and 6 indicates rigidity.
Modified Ashworth Scale Scores:
0 (0) - No increase in muscle tone
1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension.
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement).
2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved.
3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: One week before the intervention. One week after the intervention. One month after the intervention.
Changes in FIM
Provides a uniform system of measurement for disability based on the International Classification of Impairment, Disabilities and Handicaps; measures the level of a patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living. Contains 18 items composed of:
1. 13 motor tasks
2. 5 cognitive tasks (considered basic activities of daily living) Tasks are rated on a 7-point ordinal scale that ranges from total assistance (or complete dependence) to complete independence.
Scores range from 18 (lowest) to 126 (highest) indicating level of function.
Dimensions assessed include:
1. Eating
2. Grooming
3. Bathing
4. Upper body dressing
5. Lower body dressing
6. Toileting
7. Bladder management
8. Bowel management
9. Bed to chair transfer
10. Toilet transfer
11. Shower transfer
12. Locomotion (ambulatory or wheelchair level)
13. Stairs
14. Cognitive comprehension
15. Expression
16. Social interaction
17. Problem
Measured: One week before the intervention. One week after the intervention. One month after the intervention.
Changes in Quick Dash
Assessment of symptoms and functionality in upper limb's pathology.
Measured: One week before the intervention. One week after the intervention. One month after the intervention.
Changes in Action Research Arm Test (ARAT)
Assessment of coordination and manipulative skills in tasks of grasping and reaching objects.
The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from:
1. Performs test normally 2) Completes test, but takes abnormally long or has great difficulty
2. Performs test partially 0) Can perform no part of test
Lyle's decision rules:
1. Patients who achieve a maximum score on the first (most difficult) item are credited with having scored 3 on all subsequent items on that scale.
2. If the patient scores less than 3 on the first item, then the second item is assessed.
3. This is the easiest item, and if patients score 0 then they are unlikely to achieve a score above 0 for the remainder of the items and are credited with a zero for the other items.
4. The maximum score on the ARTS is 57 points (possible range 0 to 57).
Measured: One week before the intervention. One week after the intervention. One month after the intervention.
Changes in Quebec User Evaluation of Satisfaction with Assistive Technology (QTEST)
The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) was designed to measure the level of satisfaction attribute to assistive technologies. It does so using 27 variables which are scored in terms of perceived importance and satisfaction.
For each of the 12 items, rate your satisfaction with your assistive device and the related services you experienced by using the following scale of 1 to 5.
For each of the 12 items, the user has to rate their satisfaction with the assistive device and the related services their experienced by using the following scale of 1 to 5.
1 - Not satisfied at all. 2- Not very satisfied. 3 - More or less satisfied. 4 - Quite satisfied. 5 -Very satisfied.
Measured: One week before the intervention. One week after the intervention. One month after the intervention.
Changes in the Self-Assessment Manikin (SAM)
To assess the emotional response of user to different stimulus.
Measured: One week before the intervention. One week after the intervention. One month after the intervention.
Changes in isometric force
To evaluate the isometric strength of the patient
Measured: One week before the intervention. One week after the intervention. One month after the intervention.
Changes in range of movement
To evaluate the range of movement performed by the patient
Measured: One week before the intervention. One week after the intervention. One month after the intervention.
Changes in Lawton & Brody
Assessment basic and instrumental activities of daily life. It evaluates the following categories and subcategories. For each of the latest, the subject has to circle the item description that most closely resembles their highest functional level (either 0 or 1): A. Ability to Use Telephone; B. Shopping; C.Food Preparation; D.Housekeeping; E. Laundry; F. Mode of Transportation; G. Responsibility for Own Medications; H. Ability to Handle Finances.
Measured: One week before the intervention. One week after the intervention. One month after the intervention.
Changes in Box and Block
The Box and Block Test assesses unilateral gross manual dexterity. Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition. One hundred and fifty, 2.5 cm, colored, wooden cubes or blocks are placed in one compartment or the other. The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. Patient's hand must cross over the partition in order for a point to be given, and blocks that drop or bounce out of the second.
Measured: One week before the intervention. One week after the intervention. One month after the intervention.
Changes in System Usability Scale (SUS)
The System Usability Scale (SUS) provides a "quick and dirty", reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
When a SUS is used, participants are asked to score the following 10 items with one of five responses that range from Strongly Agree to Strongly disagree:
I think that I would like to use this system frequently. I found the system unnecessarily complex. I thought the system was easy to use. I think that I would need the support of a technical person to be able to use this system.
I found the various functions in this system were well integrated. I thought there was too much inconsistency in this system. I would imagine that most people would learn to use this system very quickly. I found the system very cumbersome to use. I felt very confident using the system. I needed to learn a lot of things before I could get going with this system.
Measured: One week before the intervention. One week after the intervention. One month after the intervention.

Secondary outcomes (1)

Changes in Motor Evoked Potentials (MEPs).
To assess the motor evoked potential.
Measured: One week before the intervention. One week after the intervention. One month after the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 2018May 2019

First posted25 Apr 2018
Study start12 Mar 2018
Primary completion16 Feb 2019 (estimated)
Study completionMay 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for StrokeStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 16 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03508037
Sponsor's protocol ID: CSEULS-PI-106/2016
Status last verified: Apr 2018
First submitted: 22 Mar 2018
Last updated: 21 Sep 2018
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

Oscar Herrero

+ 34 645 16 31 66

oscar.herrero@cajal.csic.es

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hybrid Robotic System and EEG Based on an Adaptative and Associative Assistance for Rehabilitation of Reaching Movements After Stroke
ClinicalTrials.gov ID: NCT03508037
Acronym / sponsor ID: CSEULS-PI-106/2016
Conditions: Stroke, Impairment Upper Limb
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 16 participants (estimated)
Lead sponsor: Cajal Institute of the Spanish National Research CouncilUniversity, hospital or other
Collaborators: Centro de Referencia Estatal de Atención Al Daño Cerebral, Centro Universitario La Salle
Study start: 12 Mar 2018 (actual)
Primary completion: 16 Feb 2019 (estimated)
Study completion: May 2019 (estimated)
First posted: 25 Apr 2018 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental group	Experimental	Other: Neuromodulation electroencephalographic signals and functional electrical stimulation basedThe subject receives the Functional Electrical Stimulation (FES) when he or she has the intention to move. It is obtained through electroencephalography.
Control group	Active comparator	Other: Neuromodulation electroencephalographic signals and functional electrical stimulation basedThe subject receives the Functional Electrical Stimulation (FES) after o before (0.5 seconds) when he or she has the intention to move. It is obtained through electroencephalography.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

With response to Transcranial Magnetic Stimulation (TMS)
Cortical or sub-cortical stroke patients
With a score in the range of 22-44 on Fugl-Meyer scale or 2-4 on the Motor Assessment Scale
With visible cortical patterns registered by BCI
Subjects that tolerate electrical stimulation and that present a motor response

Key exclusion criteria (5 listed)

Subjects with neurological injury prior to stroke or more than two events
Patients with implanted devices
Patients with severe motor paralysis
Patients with epilepsy
Patient with vision or hearing impairment

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
Neuromodulation electroencephalographic signals and functional electrical stimulation basedAlso: NeuromodulationFirst, the subject performs twenty reaching movements without assistance with the damaged arm resting on a robot (ArmeoSpring), with the aim of finding the Contingent Negative Variation (CNV). Then, he or she executes five courses of twenty movements receiving functional electrical stimulation (FES), either at the moment in which he or she wishes to move (experimental group), or half a second before or after (control group).	Other	Control group, Experimental group

Primary outcome

Changes in muscular balance's of upper limb
Time frame: One week before the intervention. One week after the intervention. One month after the intervention. (The duration of the intervention is three weeks).
The function of muscle strength testing is to evaluate the complaint of weakness, often when there is a suspected neurologic disease. It is an integral part of the neurologic exam, especially for patients with stroke, brain injury, and others neurologic problems. The most commonly accepted method of evaluating muscle strength is the Medical Research Council Manual Muscle Testing scale. This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: 0 No muscle activation 1. Trace muscle activation, such as a twitch, without achieving full range of motion 2. Muscle activation with gravity eliminated, achieving full range of motion 3. Muscle activation against gravity, full range of motion 4. Muscle activation against some resistance, full range of motion 5. Muscle activation against examiner's full resistance, full range of motion
Changes in modified scale of Answorth
Time frame: One week before the intervention. One week after the intervention. One month after the intervention.
Modified Ashworth Scale tests resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 6 choices. A score of 1 indicates no resistance, and 6 indicates rigidity. Modified Ashworth Scale Scores: 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension. 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement). 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved. 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Changes in FIM
Time frame: One week before the intervention. One week after the intervention. One month after the intervention.
Provides a uniform system of measurement for disability based on the International Classification of Impairment, Disabilities and Handicaps; measures the level of a patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living. Contains 18 items composed of: 1. 13 motor tasks 2. 5 cognitive tasks (considered basic activities of daily living) Tasks are rated on a 7-point ordinal scale that ranges from total assistance (or complete dependence) to complete independence. Scores range from 18 (lowest) to 126 (highest) indicating level of function. Dimensions assessed include: 1. Eating 2. Grooming 3. Bathing 4. Upper body dressing 5. Lower body dressing 6. Toileting 7. Bladder management 8. Bowel management 9. Bed to chair transfer 10. Toilet transfer 11. Shower transfer 12. Locomotion (ambulatory or wheelchair level) 13. Stairs 14. Cognitive comprehension 15. Expression 16. Social interaction 17. Problem
Changes in Quick Dash
Time frame: One week before the intervention. One week after the intervention. One month after the intervention.
Assessment of symptoms and functionality in upper limb's pathology.
Changes in Action Research Arm Test (ARAT)
Time frame: One week before the intervention. One week after the intervention. One month after the intervention.
Assessment of coordination and manipulative skills in tasks of grasping and reaching objects. The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1) Performs test partially 0) Can perform no part of test Lyle's decision rules: 1. Patients who achieve a maximum score on the first (most difficult) item are credited with having scored 3 on all subsequent items on that scale. 2. If the patient scores less than 3 on the first item, then the second item is assessed. 3. This is the easiest item, and if patients score 0 then they are unlikely to achieve a score above 0 for the remainder of the items and are credited with a zero for the other items. 4. The maximum score on the ARTS is 57 points (possible range 0 to 57).
Changes in Quebec User Evaluation of Satisfaction with Assistive Technology (QTEST)
Time frame: One week before the intervention. One week after the intervention. One month after the intervention.
The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) was designed to measure the level of satisfaction attribute to assistive technologies. It does so using 27 variables which are scored in terms of perceived importance and satisfaction. For each of the 12 items, rate your satisfaction with your assistive device and the related services you experienced by using the following scale of 1 to 5. For each of the 12 items, the user has to rate their satisfaction with the assistive device and the related services their experienced by using the following scale of 1 to 5. 1 - Not satisfied at all. 2- Not very satisfied. 3 - More or less satisfied. 4 - Quite satisfied. 5 -Very satisfied.
Changes in the Self-Assessment Manikin (SAM)
Time frame: One week before the intervention. One week after the intervention. One month after the intervention.
To assess the emotional response of user to different stimulus.
Changes in isometric force
Time frame: One week before the intervention. One week after the intervention. One month after the intervention.
To evaluate the isometric strength of the patient
Changes in range of movement
Time frame: One week before the intervention. One week after the intervention. One month after the intervention.
To evaluate the range of movement performed by the patient
Changes in Lawton & Brody
Time frame: One week before the intervention. One week after the intervention. One month after the intervention.
Assessment basic and instrumental activities of daily life. It evaluates the following categories and subcategories. For each of the latest, the subject has to circle the item description that most closely resembles their highest functional level (either 0 or 1): A. Ability to Use Telephone; B. Shopping; C.Food Preparation; D.Housekeeping; E. Laundry; F. Mode of Transportation; G. Responsibility for Own Medications; H. Ability to Handle Finances.
Changes in Box and Block
Time frame: One week before the intervention. One week after the intervention. One month after the intervention.
The Box and Block Test assesses unilateral gross manual dexterity. Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition. One hundred and fifty, 2.5 cm, colored, wooden cubes or blocks are placed in one compartment or the other. The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. Patient's hand must cross over the partition in order for a point to be given, and blocks that drop or bounce out of the second.
Changes in System Usability Scale (SUS)
Time frame: One week before the intervention. One week after the intervention. One month after the intervention.
The System Usability Scale (SUS) provides a "quick and dirty", reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. When a SUS is used, participants are asked to score the following 10 items with one of five responses that range from Strongly Agree to Strongly disagree: I think that I would like to use this system frequently. I found the system unnecessarily complex. I thought the system was easy to use. I think that I would need the support of a technical person to be able to use this system. I found the various functions in this system were well integrated. I thought there was too much inconsistency in this system. I would imagine that most people would learn to use this system very quickly. I found the system very cumbersome to use. I felt very confident using the system. I needed to learn a lot of things before I could get going with this system.

1 secondary outcome

Changes in Motor Evoked Potentials (MEPs).
Time frame: One week before the intervention. One week after the intervention. One month after the intervention.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
Individual participant dataSharing planned: Undecided

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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.

Oscar Herrero contact

+ 34 645 16 31 66

oscar.herrero@cajal.csic.es

Jose Luis Pons principal investigator

Centro Superior de Investigaciones Científicas (CSIC)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 21 Sep 2018. 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. 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 Oscar Herrero (+ 34 645 16 31 66, oscar.herrero@cajal.csic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in muscular balance's of upper limb (time frame: One week before the intervention. One week after the intervention. One month after the intervention. (The duration of the intervention is three weeks).). The study lists 12 primary outcomes in all. 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 NCT03508037.

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 21 Sep 2018; AzTrials last refreshed its copy on 3 Nov 2026.