StrokeARTS-BCINCT01287975
Brain Computer Interface (BCI) Technology for Stroke Hand Rehabilitation
A study testing Occupational Therapy, BCI Haptic Knob and Haptic Knob in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
This study is carried out to find out if Brain Computer Interface (BCI) technology or BCI technology coupled with robotic technology using a Haptic Knob will benefit patients with arm paralysis after stroke. BCI uses EEG-based motor imagery to detect user's thinking abilities which control motor movement. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Occupational Therapy, BCI Haptic Knob and Haptic Knob
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2011to Jun 2013
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 21-80 years with first-ever clinical stroke, within 1-24 months onset.
- Stroke type: ischemic or haemorhagic.
- Fugl-Meyer motor score of the upper limb range from 10-50 or
- Motor power MRC grade 3-5 in shoulder abductors and elbow flexors, and 0-3 in wrist dorsiflexors and finger flexors
- Ability to pay attention and maintain supported sitting for 1 hour continuously.
- Able to give own consent and understand simple instructions
- Fulfills BCI and Haptic knob physical screening trial.
Who cannot join
- Functional status: severe aphasia or inattention, unstable medical conditions which may affect participation (e.g. unresolved sepsis, postural hypotension, end stage renal failure) or anticipated life expectancy of <1 year due to malignancy or neurodegenerative disorder)
- Hemispatial neglect (visual or sensory) or severe visual impairment despite visual aids.
- Epilepsy, severe depression or psychiatric disorder.
- Recurrent stroke
- Skull defect as this would affect physical fit of EEG cap interface.
- Local arm factors: Severe spasticity Modified Ashworth scale >2 in any region, visual analogue scale (VAS score) >4/10, fixed joint contracture , patients with poor skin conditions, infections or eczema which may potentially be worsened by robotic shell contact.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Tan Tock Seng Hospital Rehabilitation Centre
Singapore, 569766
About this study
Official title: ARTS-BCI: Advanced Brain Computer Interface (BCI) Technology for Wrist and Hand Rehabilitation After Stroke
This study is carried out to find out if Brain Computer Interface (BCI) technology or BCI technology coupled with robotic technology using a Haptic Knob will benefit patients with arm paralysis after stroke. BCI uses EEG-based motor imagery to detect user's thinking abilities which control motor movement. Haptic Knob is a novel robotic device, which specifically trains the wrist and hand with intensive repetitions in a supported environment.
Read the detailed description
Physical therapy approaches are the de facto rehabilitation for stroke, which involve human therapists to assist stroke patients in recovering their motor ability. Modern rehabilitation technologies include robotics, functional electrical stimulation, transcranial magnetic stimulation and virtual reality. Robotic rehabilitation alleviates the labor-intensive aspects of physical rehabilitation by human therapists and could potentially improve the productivity of stroke rehabilitation. However, it is fundamentally based on movement repetition with visual feedback that helps stroke patients improve motor ability in their weak stroke-affected arms and legs. However, the robot is still able to move the weak part of the patient even if the patient is not attentive towards the training and thus the robotic training becomes a passive activity. In contrast, BCI-based robotic training works by ensuring active engagement by the hemiparetic patients in making a volitional movement. In addition, hemiplegic or locked-in stroke patients who do not have any motor power on the affected limbs are then able to engage and perform a volitional movement on these affected limbs.
BCI-based robotic rehabilitation fills this gap by detecting the motor intent of hemiplegic patients from the Electroencephalogram (EEG) signals to drive the robotic rehabilitation. This BCI-based robotic rehabilitation for stroke research project was jointly conducted by Tan Tock Seng Hospital (TTSH), National Neuroscience Institute (NNI) and Institute for Infocomm Research (I2R). Preliminary clinical trials performed at TTSH have shown that stroke patients can operate the BCI as effective as healthy subjects.
Specifically, this research project will address the following gaps in the area of rehabilitation for stroke:
- Single-modal BCI - The current system employs a single modal non-invasive EEG-based BCI that detects motor intent using at least 2.5 seconds of EEG data. Hence, the research of an advanced multi-modal BCI such as synergizing near-infrared spectroscopy with EEG to yield a more responsive and effective BCI-based robotic rehabilitation system is proposed.
- Standard therapy - The current system employs a standard therapy for all the stroke patients. However, physiotherapists and occupational therapists usually adopt a more individualized therapy for each stroke patients. Hence, research on an individualized therapy for each stroke patient according to his or her learning rate and neurological insult is proposed.
- Only physiological rehabilitation - The current system only performs physiological rehabilitation of motor functions of stroke patients. Currently some validated scales for post-stroke depression such as Beck depression inventory, CES-D, Zung scale, State trait, HADS etc are difficult to administer in stroke patients who cannot participate with assessment due to impaired language or cognitive abilities. Hence an advanced BCI-based rehabilitation system that also detects the mental state of the stroke patient is proposed to cover both physiological and psychological rehabilitation.
- Upper Limb rehabilitation - The current system which uses the clinically-proven MIT Manus robotic rehabilitation system, only performs upper limb rehabilitation for stroke patients in gross reach patterns. Human hand skills, in contrast, consist of more complex manipulation movement patterns which can be intervened by BCI-based robotic rehabilitation. Hence, an advanced BCI-based rehabilitation system that covers the hand function is proposed to cover the rehabilitation of the entire upper extremity.
- Conditions
- Stroke
- Being tested
- Occupational Therapy, BCI Haptic Knob, Haptic Knob
- Keywords
- Stroke Rehabilitation, Brain Computer Interface, Upper Limb Rehabilitation, EEG-based Motor Imagery, Robotic Rehabilitation, Haptic Knob
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational TherapyOther
Use of conventional manual facilitation and function-based training used in conventional occupational therapy training for post-stroke upper limb weakness.
Training is modelled along the neurodevelopmental techniques and will include stretching, tone management, weight bearing exercises, movement facilitation, selfcare training, arm ergometry by arm bicycles and grip strength training.
Training intensity is 1.5 hours for 3 times a week for 6 weeks consecutively.
BCI Haptic KnobDevice
BCI based robotic rehabilitation works by detecting the motor intent of the user from electroencephalogram signals to drive the robotic rehabilitation via Haptic Knob. Training intensity is 1.5 hours for 3 times a week for 6 weeks consecutively.
Haptic KnobDevice
Haptic Knob is an upper limb robot designed for use in robotic-assisted rehabilitation of the stroke wrist and hand. Training intensity is 1.5 hours for 3 times a week for 6 weeks consecutively.
| Study group | Role | What they receive |
|---|---|---|
| Standard Occupational Therapy | Active comparator | Standard Occupational Therapy for Wrist and Hand Training Receives: Other: Occupational Therapy |
| BCI Haptic Knob | Experimental | BCI controlled robotic-assisted training for wrist and hand Receives: Device: BCI Haptic Knob |
| Haptic Knob | Experimental | Robotic-assisted training for wrist and hand Receives: Device: Haptic Knob |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test
Measures the change of upper limb motor function post-stroke
Measured: Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Fugl Myer Upper Limb Motor Assessment
Measures changes in post-stroke upper limb movement
Measured: Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Secondary outcomes (5)
Frenchay Arm Test
To measure performance in functional hand use post stroke
Measured: Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Grip Strength
Use of grip dynamometer to measure changes in grip strength
Measured: Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Modified Ashworth Scale
Measure changes in spasticity of the affected limb
Measured: Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Functional Independence Measure (Motor)
Measures participation in activities of daily living.
Measured: Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Pain Score
Use of visual analogue scale of 0-10 for pain measurement
Measured: Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Infocomm Research
- Responsible party
- Principal investigator, Chua Sui Geok, Karen, Tan Tock Seng Hospital
- Investigators
- Karen SG Chua, MD, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287975
- Sponsor's protocol ID
- SERC Grant No: 092 148 0066
- Acronym
- ARTS-BCI
- Status last verified
- Feb 2018
- First submitted
- 26 Jan 2011
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ang KK, Guan C, Chua KS, Ang BT, Kuah C, Wang C, Phua KS, Chin ZY, Zhang H. Clinical study of neurorehabilitation in stroke using EEG-based motor imagery brain-computer interface with robotic feedback. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:5549-52. doi: 10.1109/IEMBS.2010.5626782.
PubMed 21096475Arvaneh M, Guan C, Ang KK, Ward TE, Chua KSG, Kuah CWK, Ephraim Joseph GJ, Phua KS, Wang C. Facilitating motor imagery-based brain-computer interface for stroke patients using passive movement. Neural Comput Appl. 2017;28(11):3259-3272. doi: 10.1007/s00521-016-2234-7. Epub 2016 Mar 4.
PubMed 29051688Ang KK, Guan C, Phua KS, Wang C, Zhou L, Tang KY, Ephraim Joseph GJ, Kuah CW, Chua KS. Brain-computer interface-based robotic end effector system for wrist and hand rehabilitation: results of a three-armed randomized controlled trial for chronic stroke. Front Neuroeng. 2014 Jul 29;7:30. doi: 10.3389/fneng.2014.00030. eCollection 2014.
PubMed 25120465Ang KK, Guan C, Chua KS, Phua KS, Wang C, Chin ZY, Zhou L, Tang KY, Joseph GJ, Kuah C. A clinical study of motor imagery BCI performance in stroke by including calibration data from passive movement. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:6603-6. doi: 10.1109/EMBC.2013.6611069.
PubMed 24111256
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARTS-BCI: Advanced Brain Computer Interface (BCI) Technology for Wrist and Hand Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT01287975
- Acronym / sponsor ID
- ARTS-BCI / SERC Grant No: 092 148 0066
- Conditions
- Stroke
- Keywords
- Stroke Rehabilitation, Brain Computer Interface, Upper Limb Rehabilitation, EEG-based Motor Imagery, Robotic Rehabilitation, Haptic Knob
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Institute for Infocomm Research
- Study start
- Jan 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Feb 2011 (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.
This study is carried out to find out if Brain Computer Interface (BCI) technology or BCI technology coupled with robotic technology using a Haptic Knob will benefit patients with arm paralysis after stroke. BCI uses EEG-based motor imagery to detect user's thinking abilities which control motor movement. Haptic Knob is a novel robotic device, which specifically trains the wrist and hand with intensive repetitions in a supported environment.
Detailed description
Physical therapy approaches are the de facto rehabilitation for stroke, which involve human therapists to assist stroke patients in recovering their motor ability. Modern rehabilitation technologies include robotics, functional electrical stimulation, transcranial magnetic stimulation and virtual reality. Robotic rehabilitation alleviates the labor-intensive aspects of physical rehabilitation by human therapists and could potentially improve the productivity of stroke rehabilitation. However, it is fundamentally based on movement repetition with visual feedback that helps stroke patients improve motor ability in their weak stroke-affected arms and legs. However, the robot is still able to move the weak part of the patient even if the patient is not attentive towards the training and thus the robotic training becomes a passive activity. In contrast, BCI-based robotic training works by ensuring active engagement by the hemiparetic patients in making a volitional movement. In addition, hemiplegic or locked-in stroke patients who do not have any motor power on the affected limbs are then able to engage and perform a volitional movement on these affected limbs.
BCI-based robotic rehabilitation fills this gap by detecting the motor intent of hemiplegic patients from the Electroencephalogram (EEG) signals to drive the robotic rehabilitation. This BCI-based robotic rehabilitation for stroke research project was jointly conducted by Tan Tock Seng Hospital (TTSH), National Neuroscience Institute (NNI) and Institute for Infocomm Research (I2R). Preliminary clinical trials performed at TTSH have shown that stroke patients can operate the BCI as effective as healthy subjects.
Specifically, this research project will address the following gaps in the area of rehabilitation for stroke:
- Single-modal BCI - The current system employs a single modal non-invasive EEG-based BCI that detects motor intent using at least 2.5 seconds of EEG data. Hence, the research of an advanced multi-modal BCI such as synergizing near-infrared spectroscopy with EEG to yield a more responsive and effective BCI-based robotic rehabilitation system is proposed.
- Standard therapy - The current system employs a standard therapy for all the stroke patients. However, physiotherapists and occupational therapists usually adopt a more individualized therapy for each stroke patients. Hence, research on an individualized therapy for each stroke patient according to his or her learning rate and neurological insult is proposed.
- Only physiological rehabilitation - The current system only performs physiological rehabilitation of motor functions of stroke patients. Currently some validated scales for post-stroke depression such as Beck depression inventory, CES-D, Zung scale, State trait, HADS etc are difficult to administer in stroke patients who cannot participate with assessment due to impaired language or cognitive abilities. Hence an advanced BCI-based rehabilitation system that also detects the mental state of the stroke patient is proposed to cover both physiological and psychological rehabilitation.
- Upper Limb rehabilitation - The current system which uses the clinically-proven MIT Manus robotic rehabilitation system, only performs upper limb rehabilitation for stroke patients in gross reach patterns. Human hand skills, in contrast, consist of more complex manipulation movement patterns which can be intervened by BCI-based robotic rehabilitation. Hence, an advanced BCI-based rehabilitation system that covers the hand function is proposed to cover the rehabilitation of the entire upper extremity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Occupational Therapy | Active comparator | Other: Occupational TherapyStandard Occupational Therapy for Wrist and Hand Training |
| BCI Haptic Knob | Experimental | Device: BCI Haptic KnobBCI controlled robotic-assisted training for wrist and hand |
| Haptic Knob | Experimental | Device: Haptic KnobRobotic-assisted training for wrist and hand |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 21-80 years with first-ever clinical stroke, within 1-24 months onset.
- Stroke type: ischemic or haemorhagic.
- Fugl-Meyer motor score of the upper limb range from 10-50 or
- Motor power MRC grade 3-5 in shoulder abductors and elbow flexors, and 0-3 in wrist dorsiflexors and finger flexors
- Ability to pay attention and maintain supported sitting for 1 hour continuously.
Key exclusion criteria (6 listed)
- Functional status: severe aphasia or inattention, unstable medical conditions which may affect participation (e.g. unresolved sepsis, postural hypotension, end stage renal failure) or anticipated life expectancy of <1 year due to malignancy or neurodegenerative disorder)
- Hemispatial neglect (visual or sensory) or severe visual impairment despite visual aids.
- Epilepsy, severe depression or psychiatric disorder.
- Recurrent stroke
- Skull defect as this would affect physical fit of EEG cap interface.
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 |
|---|---|---|
| Occupational TherapyUse of conventional manual facilitation and function-based training used in conventional occupational therapy training for post-stroke upper limb weakness. Training is modelled along the neurodevelopmental techniques and will include stretching, tone management, weight bearing exercises, movement facilitation, selfcare training, arm ergometry by arm bicycles and grip strength training. Training intensity is 1.5 hours for 3 times a week for 6 weeks consecutively. | Other | Standard Occupational Therapy |
| BCI Haptic KnobBCI based robotic rehabilitation works by detecting the motor intent of the user from electroencephalogram signals to drive the robotic rehabilitation via Haptic Knob. Training intensity is 1.5 hours for 3 times a week for 6 weeks consecutively. | Device | BCI Haptic Knob |
| Haptic KnobHaptic Knob is an upper limb robot designed for use in robotic-assisted rehabilitation of the stroke wrist and hand. Training intensity is 1.5 hours for 3 times a week for 6 weeks consecutively. | Device | Haptic Knob |
Primary outcome
Action Research Arm Test
Time frame: Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Measures the change of upper limb motor function post-stroke
Fugl Myer Upper Limb Motor Assessment
Time frame: Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Measures changes in post-stroke upper limb movement
5 secondary outcomes
Frenchay Arm Test
Time frame: Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Grip Strength
Time frame: Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Modified Ashworth Scale
Time frame: Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Functional Independence Measure (Motor)
Time frame: Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Pain Score
Time frame: Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
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 27 Feb 2018.
- Background: PubMed 21096475Ang KK, Guan C, Chua KS, Ang BT, Kuah C, Wang C, Phua KS, Chin ZY, Zhang H. Clinical study of neurorehabilitation in stroke using EEG-based motor imagery brain-computer interface with robotic feedback. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:5549-52. doi: 10.1109/IEMBS.2010.5626782.
- Background: PubMed 29051688Arvaneh M, Guan C, Ang KK, Ward TE, Chua KSG, Kuah CWK, Ephraim Joseph GJ, Phua KS, Wang C. Facilitating motor imagery-based brain-computer interface for stroke patients using passive movement. Neural Comput Appl. 2017;28(11):3259-3272. doi: 10.1007/s00521-016-2234-7. Epub 2016 Mar 4.
- Background: PubMed 25120465Ang KK, Guan C, Phua KS, Wang C, Zhou L, Tang KY, Ephraim Joseph GJ, Kuah CW, Chua KS. Brain-computer interface-based robotic end effector system for wrist and hand rehabilitation: results of a three-armed randomized controlled trial for chronic stroke. Front Neuroeng. 2014 Jul 29;7:30. doi: 10.3389/fneng.2014.00030. eCollection 2014.
- Background: PubMed 24111256Ang KK, Guan C, Chua KS, Phua KS, Wang C, Chin ZY, Zhou L, Tang KY, Joseph GJ, Kuah C. A clinical study of motor imagery BCI performance in stroke by including calibration data from passive movement. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:6603-6. doi: 10.1109/EMBC.2013.6611069.
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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.
Karen SG Chua, MD principal investigator
Tan Tock Seng 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 Occupational Therapy, BCI Haptic Knob and Haptic Knob in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 7 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 27 Feb 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 Singapore. 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?
Action Research Arm Test (time frame: Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01287975, which also lists 4 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 27 Feb 2018.