Cerebral PalsyNCT03016923
Functional Electrical Stimulation (FES) for Upper Extremity Hemiplegia in Children With Cerebral Palsy
A study testing FES Therapy in people with Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital.
Trial summary
The proposed pilot study seeks to explore the effectiveness of Functional Electrical Stimulation (FES) to improve upper limb function in children and youth (aged 6 to 18 years) with hemiplegic cerebral palsy, as measured by the QUEST grasp score and other secondary outcome measures obtained pre- and post-intervention… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- FES Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to 25 Aug 2017
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of hemiplegic CP
- Age between 6 to 18 years
- Ability to cooperate, understand and follow instructions during the administration of FES paired with intensive hand therapy
- Baseline total QUEST score between 20-80 out of 100 points
- Be seizure-free for a required period of at least 1 year with or without medication , and have no prior history of known cardiac arrhythmias/stimulants
- No pacemaker or implanted metallic or electronic device
- No edema, skin rash, allergy or wound on the affected upper limb where FES will be administered.
- No Botulinum toxin upper limb injections within 6-months of study entry, and no Constraint-induced movement therapy (CIMT) within 4 months of study entry. Participants should also refrain from receiving these treatments throughout the duration of the study.
Who cannot join
- The participant's forearm is too small to accommodate the standard FES electrodes.
- The participant's muscles do not respond to the electrical stimulation as tested at the baseline assessment visit. Response to electrical stimulation will be tested at the baseline visit and is described in detail in the section entitled "Muscle Responsiveness Testing" below. Based on the Muscle Responsiveness Testing procedures and criteria, the withdrawal criteria for non-response to electrical stimulation is defined as:
- More than 3 muscle groups out of 11 not- responding to FES or
- The participant reports a discomfort level score of 8 or 10 on the FACES scale (Appendix A) for any of the 11 muscle groups.
- Participant receives any other active occupational therapy or hemiplegic hand intervention during the FES intervention period.
- Participant attends less than 36/48 FES intervention sessions.
- Participant develops new-onset seizures during the FES intervention period.
About this study
Official title: An Evaluation of the Effectiveness of Functional Electrical Stimulation Paired With Intensive Therapy to Improve Hand Function in Children With Hemiplegic Cerebral Palsy
The proposed pilot study seeks to explore the effectiveness of Functional Electrical Stimulation (FES) to improve upper limb function in children and youth (aged 6 to 18 years) with hemiplegic cerebral palsy, as measured by the QUEST grasp score and other secondary outcome measures obtained pre- and post-intervention in a case series study design.
Read the detailed description
Functional electrical stimulation (FES) has increasingly gained interest as a therapeutic intervention for the improvement of motor function in individuals with disabilities. FES involves the administration of electrical pulses to stimulate motor neurons and initiate muscle contractions, It has been used primarily for individuals with spinal cord injury or those who have experienced a stroke leading to the loss of or decreased motor function of the limbs. The repeated application of FES to the affected limb has been shown to enable individuals with hemiplegia to voluntarily control movements of the affected upper limb. A new FES system, has recently been developed and indicated for use for the improvement of arm and hand function in patients with hemiplegia due to stroke or spinal cord injury. FES is a non-invasive therapy that involves transcutaneous delivery of electrical stimulation to the affected upper limb, patient participation and the assistance of therapists to improve voluntary arm and hand movements such as reaching and grasping.
The new FES system has shown effectiveness in both adults with acute stroke and children with chronic acquired stroke. In a randomized controlled trial, FES paired with intensive therapy compared to intensive therapy alone was shown to significantly improve hand function for adults with acute stroke. Participants in the trial had limited mobility or complete immobility of the affected arm and those who received FES paired with intensive therapy had clinically significant improvements in hand movements compared to those who only received intensive therapy. Recently, transcutaneous FES paired with intensive hand therapy (3 one-hour sessions per week for 16 weeks) has more recently been shown to improve hand function in children with chronic acquired stroke.
The efficacy of FES seen in patients with stroke opens up the possibility for its use in other similar populations, including children with hemiplegic cerebral palsy (HCP). However, there is currently limited research on the efficacy of FES with this population. In a preliminary study, the use of FES alone over a treatment period of 6 weeks in children with HCP was shown to significantly improve wrist movement. However, most of the research to date on the effects of FES on children with HCP has been focused on gait and lower limb function. There is currently a lack of evidence on the effectiveness of FES paired with intensive therapy on hand function in children with HCP. FES paired with intensive therapy holds significant potential to improve the hand function of children with HCP and warrants further investigation.
Therefore, the proposed research seeks to address two main objectives:
- To investigate the effectiveness of FES to improve upper limb function in children with HCP.
- To assess the effects of FES on upper limb function in children with HCP at six months post-intervention.
- Conditions
- Cerebral Palsy
- Being tested
- FES Therapy
- Keywords
- cerebral palsy, hemiplegia, fes, grasping
- Medical subject headings
- Cerebral Palsy, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES TherapyDevice
FES therapy will be administered over the course of 1 hour sessions that will be take place 3 times per week over 16 weeks, for a total of 48 sessions.
| Study group | Role | What they receive |
|---|---|---|
| FES Therapy | Experimental | FES therapy will be administered over the course of 1 hour sessions that will be take place 3 times per week over 16 weeks, for a total of 48 sessions. Receives: Device: FES Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Upper Extremities Skills Test (QUEST) as a measure of Movement patterns and hand function
Measured: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Secondary outcomes (7)
Canadian Occupational Performance Measure (COPM) as a measure of change in a child's self-perception of occupational performance over time
Measured: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Grip Strength Test as a measure of hand and forearm muscular strength
Measured: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Jebsen-Taylor Test of Hand Function (JTTHF) as a measure of hand functions required in activities of daily living
Measured: Change from Baseline (i.e., prior to intervention), at 4 months post-intervention, and at 6 months post-intervention. JTTHF will also be assessed at 4 weeks, 8 weeks, 12 weeks, and 16 weeks during the intervention period.
Children's Hand-use Experience Questionnaire (CHEQ) as a measure of children's experience in using the affected hand in bi-manual activities
Measured: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Proprioception Task as a measure of joint-position sense
Measured: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Two-point Orientation Discrimination (2POD) as a measure of tactile spatial acuity
Measured: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Stereognosis Test as a measure of is the ability to recognize and identify common objects through tactile manipulation without the use of visual cues
Measured: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startMar 2016
- Primary completion25 Aug 2017
- Study completion25 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darcy Fehlings, MD, MSc, Principal investigator, Holland Bloorview Kids Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016923
- Sponsor's protocol ID
- 15-549
- Status last verified
- Apr 2016
- First submitted
- 25 Apr 2016
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kapadia NM, Nagai MK, Zivanovic V, Bernstein J, Woodhouse J, Rumney P, Popovic MR. Functional electrical stimulation therapy for recovery of reaching and grasping in severe chronic pediatric stroke patients. J Child Neurol. 2014 Apr;29(4):493-9. doi: 10.1177/0883073813484088. Epub 2013 Apr 12.
PubMed 23584687Thrasher TA, Zivanovic V, McIlroy W, Popovic MR. Rehabilitation of reaching and grasping function in severe hemiplegic patients using functional electrical stimulation therapy. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):706-14. doi: 10.1177/1545968308317436.
PubMed 18971385Kawashima N, Popovic MR, Zivanovic V. Effect of intensive functional electrical stimulation therapy on upper-limb motor recovery after stroke: case study of a patient with chronic stroke. Physiother Can. 2013 Winter;65(1):20-8. doi: 10.3138/ptc.2011-36.
PubMed 24381377Sheffler LR, Chae J. Neuromuscular electrical stimulation in neurorehabilitation. Muscle Nerve. 2007 May;35(5):562-90. doi: 10.1002/mus.20758.
PubMed 17299744Quandt F, Hummel FC. The influence of functional electrical stimulation on hand motor recovery in stroke patients: a review. Exp Transl Stroke Med. 2014 Aug 21;6:9. doi: 10.1186/2040-7378-6-9. eCollection 2014.
PubMed 25276333Meadmore KL, Exell TA, Hallewell E, Hughes AM, Freeman CT, Kutlu M, Benson V, Rogers E, Burridge JH. The application of precisely controlled functional electrical stimulation to the shoulder, elbow and wrist for upper limb stroke rehabilitation: a feasibility study. J Neuroeng Rehabil. 2014 Jun 30;11:105. doi: 10.1186/1743-0003-11-105.
PubMed 24981060Golomb MR, Garg BP, Saha C, Azzouz F, Williams LS. Cerebral palsy after perinatal arterial ischemic stroke. J Child Neurol. 2008 Mar;23(3):279-86. doi: 10.1177/0883073807309246.
PubMed 18305317Prosser LA, Curatalo LA, Alter KE, Damiano DL. Acceptability and potential effectiveness of a foot drop stimulator in children and adolescents with cerebral palsy. Dev Med Child Neurol. 2012 Nov;54(11):1044-9. doi: 10.1111/j.1469-8749.2012.04401.x. Epub 2012 Aug 27.
PubMed 22924431Wright PA, Granat MH. Therapeutic effects of functional electrical stimulation of the upper limb of eight children with cerebral palsy. Dev Med Child Neurol. 2000 Nov;42(11):724-7. doi: 10.1017/s0012162200001341.
PubMed 11104342Postans NJ, Granat MH. Effect of functional electrical stimulation, applied during walking, on gait in spastic cerebral palsy. Dev Med Child Neurol. 2005 Jan;47(1):46-52. doi: 10.1017/s0012162205000083.
PubMed 15686289Staudt M, Gerloff C, Grodd W, Holthausen H, Niemann G, Krageloh-Mann I. Reorganization in congenital hemiparesis acquired at different gestational ages. Ann Neurol. 2004 Dec;56(6):854-63. doi: 10.1002/ana.20297.
PubMed 15562409
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effectiveness of Functional Electrical Stimulation Paired With Intensive Therapy to Improve Hand Function in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03016923
- Acronym / sponsor ID
- 15-549
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, hemiplegia, fes, grasping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 25 Aug 2017 (actual)
- Study completion
- 25 Aug 2017 (actual)
- First posted
- 11 Jan 2017 (estimated)
- 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 proposed pilot study seeks to explore the effectiveness of Functional Electrical Stimulation (FES) to improve upper limb function in children and youth (aged 6 to 18 years) with hemiplegic cerebral palsy, as measured by the QUEST grasp score and other secondary outcome measures obtained pre- and post-intervention in a case series study design.
Detailed description
Functional electrical stimulation (FES) has increasingly gained interest as a therapeutic intervention for the improvement of motor function in individuals with disabilities. FES involves the administration of electrical pulses to stimulate motor neurons and initiate muscle contractions, It has been used primarily for individuals with spinal cord injury or those who have experienced a stroke leading to the loss of or decreased motor function of the limbs. The repeated application of FES to the affected limb has been shown to enable individuals with hemiplegia to voluntarily control movements of the affected upper limb. A new FES system, has recently been developed and indicated for use for the improvement of arm and hand function in patients with hemiplegia due to stroke or spinal cord injury. FES is a non-invasive therapy that involves transcutaneous delivery of electrical stimulation to the affected upper limb, patient participation and the assistance of therapists to improve voluntary arm and hand movements such as reaching and grasping.
The new FES system has shown effectiveness in both adults with acute stroke and children with chronic acquired stroke. In a randomized controlled trial, FES paired with intensive therapy compared to intensive therapy alone was shown to significantly improve hand function for adults with acute stroke. Participants in the trial had limited mobility or complete immobility of the affected arm and those who received FES paired with intensive therapy had clinically significant improvements in hand movements compared to those who only received intensive therapy. Recently, transcutaneous FES paired with intensive hand therapy (3 one-hour sessions per week for 16 weeks) has more recently been shown to improve hand function in children with chronic acquired stroke.
The efficacy of FES seen in patients with stroke opens up the possibility for its use in other similar populations, including children with hemiplegic cerebral palsy (HCP). However, there is currently limited research on the efficacy of FES with this population. In a preliminary study, the use of FES alone over a treatment period of 6 weeks in children with HCP was shown to significantly improve wrist movement. However, most of the research to date on the effects of FES on children with HCP has been focused on gait and lower limb function. There is currently a lack of evidence on the effectiveness of FES paired with intensive therapy on hand function in children with HCP. FES paired with intensive therapy holds significant potential to improve the hand function of children with HCP and warrants further investigation.
Therefore, the proposed research seeks to address two main objectives:
- To investigate the effectiveness of FES to improve upper limb function in children with HCP.
- To assess the effects of FES on upper limb function in children with HCP at six months post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FES Therapy | Experimental | Device: FES TherapyFES therapy will be administered over the course of 1 hour sessions that will be take place 3 times per week over 16 weeks, for a total of 48 sessions. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Diagnosis of hemiplegic CP
- Age between 6 to 18 years
- Ability to cooperate, understand and follow instructions during the administration of FES paired with intensive hand therapy
- Baseline total QUEST score between 20-80 out of 100 points
- Be seizure-free for a required period of at least 1 year with or without medication , and have no prior history of known cardiac arrhythmias/stimulants
Key exclusion criteria (7 listed)
- The participant's forearm is too small to accommodate the standard FES electrodes.
- The participant's muscles do not respond to the electrical stimulation as tested at the baseline assessment visit. Response to electrical stimulation will be tested at the baseline visit and is described in detail in the section entitled "Muscle Responsiveness Testing" below. Based on the Muscle Responsiveness Testing procedures and criteria, the withdrawal criteria for non-response to electrical stimulation is defined as:
- Participant receives any other active occupational therapy or hemiplegic hand intervention during the FES intervention period.
- Participant attends less than 36/48 FES intervention sessions.
- Participant develops new-onset seizures during the FES intervention period.
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 |
|---|---|---|
| FES TherapyFES therapy will be administered over the course of 1 hour sessions that will be take place 3 times per week over 16 weeks, for a total of 48 sessions. | Device | FES Therapy |
Primary outcome
Quality of Upper Extremities Skills Test (QUEST) as a measure of Movement patterns and hand function
Time frame: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
7 secondary outcomes
Canadian Occupational Performance Measure (COPM) as a measure of change in a child's self-perception of occupational performance over time
Time frame: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Grip Strength Test as a measure of hand and forearm muscular strength
Time frame: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Jebsen-Taylor Test of Hand Function (JTTHF) as a measure of hand functions required in activities of daily living
Time frame: Change from Baseline (i.e., prior to intervention), at 4 months post-intervention, and at 6 months post-intervention. JTTHF will also be assessed at 4 weeks, 8 weeks, 12 weeks, and 16 weeks during the intervention period.
Children's Hand-use Experience Questionnaire (CHEQ) as a measure of children's experience in using the affected hand in bi-manual activities
Time frame: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Proprioception Task as a measure of joint-position sense
Time frame: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Two-point Orientation Discrimination (2POD) as a measure of tactile spatial acuity
Time frame: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Stereognosis Test as a measure of is the ability to recognize and identify common objects through tactile manipulation without the use of visual cues
Time frame: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-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 26 Feb 2018.
- Background: PubMed 23584687Kapadia NM, Nagai MK, Zivanovic V, Bernstein J, Woodhouse J, Rumney P, Popovic MR. Functional electrical stimulation therapy for recovery of reaching and grasping in severe chronic pediatric stroke patients. J Child Neurol. 2014 Apr;29(4):493-9. doi: 10.1177/0883073813484088. Epub 2013 Apr 12.
- Background: PubMed 18971385Thrasher TA, Zivanovic V, McIlroy W, Popovic MR. Rehabilitation of reaching and grasping function in severe hemiplegic patients using functional electrical stimulation therapy. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):706-14. doi: 10.1177/1545968308317436.
- Background: PubMed 24381377Kawashima N, Popovic MR, Zivanovic V. Effect of intensive functional electrical stimulation therapy on upper-limb motor recovery after stroke: case study of a patient with chronic stroke. Physiother Can. 2013 Winter;65(1):20-8. doi: 10.3138/ptc.2011-36.
- Background: PubMed 17299744Sheffler LR, Chae J. Neuromuscular electrical stimulation in neurorehabilitation. Muscle Nerve. 2007 May;35(5):562-90. doi: 10.1002/mus.20758.
- Background: PubMed 25276333Quandt F, Hummel FC. The influence of functional electrical stimulation on hand motor recovery in stroke patients: a review. Exp Transl Stroke Med. 2014 Aug 21;6:9. doi: 10.1186/2040-7378-6-9. eCollection 2014.
- Background: PubMed 24981060Meadmore KL, Exell TA, Hallewell E, Hughes AM, Freeman CT, Kutlu M, Benson V, Rogers E, Burridge JH. The application of precisely controlled functional electrical stimulation to the shoulder, elbow and wrist for upper limb stroke rehabilitation: a feasibility study. J Neuroeng Rehabil. 2014 Jun 30;11:105. doi: 10.1186/1743-0003-11-105.
- Background: PubMed 18305317Golomb MR, Garg BP, Saha C, Azzouz F, Williams LS. Cerebral palsy after perinatal arterial ischemic stroke. J Child Neurol. 2008 Mar;23(3):279-86. doi: 10.1177/0883073807309246.
- Background: PubMed 22924431Prosser LA, Curatalo LA, Alter KE, Damiano DL. Acceptability and potential effectiveness of a foot drop stimulator in children and adolescents with cerebral palsy. Dev Med Child Neurol. 2012 Nov;54(11):1044-9. doi: 10.1111/j.1469-8749.2012.04401.x. Epub 2012 Aug 27.
- Background: PubMed 11104342Wright PA, Granat MH. Therapeutic effects of functional electrical stimulation of the upper limb of eight children with cerebral palsy. Dev Med Child Neurol. 2000 Nov;42(11):724-7. doi: 10.1017/s0012162200001341.
- Background: PubMed 15686289Postans NJ, Granat MH. Effect of functional electrical stimulation, applied during walking, on gait in spastic cerebral palsy. Dev Med Child Neurol. 2005 Jan;47(1):46-52. doi: 10.1017/s0012162205000083.
- Background: PubMed 15562409Staudt M, Gerloff C, Grodd W, Holthausen H, Niemann G, Krageloh-Mann I. Reorganization in congenital hemiparesis acquired at different gestational ages. Ann Neurol. 2004 Dec;56(6):854-63. doi: 10.1002/ana.20297.
- 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.
Darcy Fehlings, MD, MSc principal investigator
Holland Bloorview Kids Rehabilitation Hospital
Questions about this trial
What is this clinical trial studying?
A study testing FES Therapy in people with Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital.
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 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: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Quality of Upper Extremities Skills Test (QUEST) as a measure of Movement patterns and hand function (time frame: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-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 NCT03016923, which also lists 11 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 26 Feb 2018.