Executive DysfunctionNIBSNCT02740530
Improving Mobility and Cognition in Older Adults Using Non-Invasive Brain Stimulation
A study testing Magstim® Rapid 2 machine in people with Executive Dysfunction and Gait Performance, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This study aims to test the efficacy of a type of non-invasive brain stimulation (NIBS), known as repetitive transcranial magnetic (rTMS) stimulation, in improving mobility, particularly gait stability and variability, and executive dysfunction in older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Executive Dysfunction, Gait Performance, Repetitive Transcranial Magnetic Stimulation
- What is being tested?
- Magstim® Rapid 2 machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to May 2023
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having executive dysfunction (defined as score below 11 out of a possible 13 in the "Montreal Cognitive Assessment -MoCA- executive score index")
- Age 60 years and older
- English speaking
- Able to ambulate 10m independently without any gait aid (eg. walker, cane)
Who cannot join
- Unable to understand or communicate in English
- Parkinsonism or any neurological disorder with residual motor deficit (eg. Major stroke, epilepsy)
- Musculoskeletal disorder detected by clinical examination which affects gait performance -Active osteoarthritis affecting lower limbs (American College of Rheumatology criteria)
- Severe depression operationalized as Geriatric Depression Scale (GDS) score>10
- TMS specific exclusion criteria:
- Persons with metal anywhere in the head, excluding the mouth, including shrapnel, and screws and clips from surgical procedures
Show all 11Show fewer
- Persons with cardiac pacemakers, implanted medication pumps, electrodes inside the heart
- Unstable heart disease
- Persons with increased intracranial pressure, as in acute large infarctions or trauma
- Previous major stroke, history seizure, Parkinson D, Huntington D.
- History of schizophrenia/schizo-affective disorder, substance use disorder within 1 year of study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Mobility and Cognition in Older Adults: Establishment of an Interdisciplinary Clinical Research Program Using Non-Invasive Brain Stimulation
This study aims to test the efficacy of a type of non-invasive brain stimulation (NIBS), known as repetitive transcranial magnetic (rTMS) stimulation, in improving mobility, particularly gait stability and variability, and executive dysfunction in older adults. The study will be conducted in forty older adults (≥60 years) with a diagnosis of executive dysfunction.
Read the detailed description
The proposed study using rTMS will build upon the investigators previous work demonstrating the link between cognitive impairment, particularly executive dysfunction, and mobility/gait abnormalities in older adults, even in those labeled as "cognitively normal". Emerging evidence demonstrates that executive dysfunction is an early phenomenon in the pathway to mobility disability and subtle changes in executive function are independently associated with future falls. The investigators have piloted studies showing that pharmacological enhancement of executive function, can improve gait-motor performance and, potentially, reduce mobility decline and risk of falls. This supports the rationale for a promising intervention: enhancing cognition to prevent mobility decline and reduce risk of falls. The long-term goal is to create a clinical research program to apply rTMS as an early novel intervention for cognitive/motor interaction to ultimately delay the onset of cognitive and mobility disabilities and their devastating consequences, dementia and falls, in older adults. However, it is first necessary to study a smaller group of seniors to plan for recruitment, study retention and compliance, and to gather preliminary data as proof of principle before proceeding to a larger clinical trial.
- Being tested
- Magstim® Rapid 2 machine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magstim® Rapid 2 machineDevice
Also called MAGSTIM® RAPID II SYSTEM License number 69773
See Arms description
| Study group | Role | What they receive |
|---|---|---|
| rTMS Active | Experimental | High frequency pulsed repetitive magnetic stimulation at 100 % resting motor threshold will be delivered using a figure of 8 air film cooled coil attached to the Magstim® Rapid 2 machine. Resting motor threshold will be determined minimum energy needed to elicit the a reliable visible contraction in the contra-lateral first interosseous muscle using single pulse rTMS applied to the area between C1-C3 using the 10-20 international EEG electrode system. For stimulation, the coil will be positioned on the scalp corresponding to F4 then F3 electrode position using the 10-20 international EEG system. Real stimulation will consist of delivering 1200 pulses at 20 hz frequency to F4 location followed by the same stimulation to F3. The total time needed to deliver pulses is 20 minutes. Receives: Device: Magstim® Rapid 2 machine |
| rTMS Sham | Placebo comparator | Sham stimulation will also involve delivering the same stimulus but with angulation of the coil at 45 degrees, which will give similar scalp sensation but unlikely to deliver magnetic stimulation to the cortex Receives: Device: Magstim® Rapid 2 machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait velocity - cm/s
Measured: Seven days
Secondary outcomes (1)
Executive function, assessed as time to take to complete Trail Making A and B (TMT A and B) in seconds.
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2022
- Study completionMay 2023
Why it stopped: Unforeseen challenges that rendered Recruitment more challenging than expected. Thus, recruitment is terminated earlier to proceed with data analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Executive DysfunctionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Montero Odasso, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Manuel Montero Odasso, MD,PhD, Principal investigator, Lawson Health Research Institute, Western University, St. Joseph's Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740530
- Sponsor's protocol ID
- 107526
- Acronym
- NIBS
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2016
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the proof of principle nature of this study, our data will be crucial to establish efficacy of the intervention and furhet apply for funding for larger, clinical trial to test efectiveness
Publications
Montero-Odasso M, Verghese J, Beauchet O, Hausdorff JM. Gait and cognition: a complementary approach to understanding brain function and the risk of falling. J Am Geriatr Soc. 2012 Nov;60(11):2127-36. doi: 10.1111/j.1532-5415.2012.04209.x. Epub 2012 Oct 30.
PubMed 23110433Montero-Odasso M, Hachinski V. Preludes to brain failure: executive dysfunction and gait disturbances. Neurol Sci. 2014 Apr;35(4):601-4. doi: 10.1007/s10072-013-1613-4. Epub 2013 Dec 24.
PubMed 24366243Shaw FE. Prevention of falls in older people with dementia. J Neural Transm (Vienna). 2007;114(10):1259-64. doi: 10.1007/s00702-007-0741-5. Epub 2007 Jun 8.
PubMed 17557130Oliver D, Connelly JB, Victor CR, Shaw FE, Whitehead A, Genc Y, Vanoli A, Martin FC, Gosney MA. Strategies to prevent falls and fractures in hospitals and care homes and effect of cognitive impairment: systematic review and meta-analyses. BMJ. 2007 Jan 13;334(7584):82. doi: 10.1136/bmj.39049.706493.55. Epub 2006 Dec 8.
PubMed 17158580Shaw FE, Bond J, Richardson DA, Dawson P, Steen IN, McKeith IG, Kenny RA. Multifactorial intervention after a fall in older people with cognitive impairment and dementia presenting to the accident and emergency department: randomised controlled trial. BMJ. 2003 Jan 11;326(7380):73. doi: 10.1136/bmj.326.7380.73.
PubMed 12521968Connolly KR, Helmer A, Cristancho MA, Cristancho P, O'Reardon JP. Effectiveness of transcranial magnetic stimulation in clinical practice post-FDA approval in the United States: results observed with the first 100 consecutive cases of depression at an academic medical center. J Clin Psychiatry. 2012 Apr;73(4):e567-73. doi: 10.4088/JCP.11m07413.
PubMed 22579164Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
PubMed 19833552Andrews SC, Hoy KE, Enticott PG, Daskalakis ZJ, Fitzgerald PB. Improving working memory: the effect of combining cognitive activity and anodal transcranial direct current stimulation to the left dorsolateral prefrontal cortex. Brain Stimul. 2011 Apr;4(2):84-9. doi: 10.1016/j.brs.2010.06.004. Epub 2010 Jul 11.
PubMed 21511208Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.
PubMed 15999258Luber B, Kinnunen LH, Rakitin BC, Ellsasser R, Stern Y, Lisanby SH. Facilitation of performance in a working memory task with rTMS stimulation of the precuneus: frequency- and time-dependent effects. Brain Res. 2007 Jan 12;1128(1):120-9. doi: 10.1016/j.brainres.2006.10.011. Epub 2006 Nov 20.
PubMed 17113573Barr MS, Farzan F, Rajji TK, Voineskos AN, Blumberger DM, Arenovich T, Fitzgerald PB, Daskalakis ZJ. Can repetitive magnetic stimulation improve cognition in schizophrenia? Pilot data from a randomized controlled trial. Biol Psychiatry. 2013 Mar 15;73(6):510-7. doi: 10.1016/j.biopsych.2012.08.020. Epub 2012 Oct 3.
PubMed 23039931Doruk D, Gray Z, Bravo GL, Pascual-Leone A, Fregni F. Effects of tDCS on executive function in Parkinson's disease. Neurosci Lett. 2014 Oct 17;582:27-31. doi: 10.1016/j.neulet.2014.08.043. Epub 2014 Aug 30.
PubMed 25179996Reis J, Robertson EM, Krakauer JW, Rothwell J, Marshall L, Gerloff C, Wassermann EM, Pascual-Leone A, Hummel F, Celnik PA, Classen J, Floel A, Ziemann U, Paulus W, Siebner HR, Born J, Cohen LG. Consensus: Can transcranial direct current stimulation and transcranial magnetic stimulation enhance motor learning and memory formation? Brain Stimul. 2008 Oct;1(4):363-9. doi: 10.1016/j.brs.2008.08.001. Epub 2008 Oct 7.
PubMed 20633394Elder GJ, Taylor JP. Transcranial magnetic stimulation and transcranial direct current stimulation: treatments for cognitive and neuropsychiatric symptoms in the neurodegenerative dementias? Alzheimers Res Ther. 2014 Nov 10;6(9):74. doi: 10.1186/s13195-014-0074-1. eCollection 2014.
PubMed 25478032Miniussi C, Cappa SF, Cohen LG, Floel A, Fregni F, Nitsche MA, Oliveri M, Pascual-Leone A, Paulus W, Priori A, Walsh V. Efficacy of repetitive transcranial magnetic stimulation/transcranial direct current stimulation in cognitive neurorehabilitation. Brain Stimul. 2008 Oct;1(4):326-36. doi: 10.1016/j.brs.2008.07.002. Epub 2008 Oct 7.
PubMed 20633391
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mobility and Cognition in Older Adults: Establishment of an Interdisciplinary Clinical Research Program Using Non-Invasive Brain Stimulation
- ClinicalTrials.gov ID
- NCT02740530
- Acronym / sponsor ID
- NIBS / 107526
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unforeseen challenges that rendered Recruitment more challenging than expected. Thus, recruitment is terminated earlier to proceed with data analysis.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Mar 2022 (actual)
- Study completion
- May 2023 (actual)
- First posted
- 15 Apr 2016 (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 aims to test the efficacy of a type of non-invasive brain stimulation (NIBS), known as repetitive transcranial magnetic (rTMS) stimulation, in improving mobility, particularly gait stability and variability, and executive dysfunction in older adults. The study will be conducted in forty older adults (≥60 years) with a diagnosis of executive dysfunction.
Detailed description
The proposed study using rTMS will build upon the investigators previous work demonstrating the link between cognitive impairment, particularly executive dysfunction, and mobility/gait abnormalities in older adults, even in those labeled as "cognitively normal". Emerging evidence demonstrates that executive dysfunction is an early phenomenon in the pathway to mobility disability and subtle changes in executive function are independently associated with future falls. The investigators have piloted studies showing that pharmacological enhancement of executive function, can improve gait-motor performance and, potentially, reduce mobility decline and risk of falls. This supports the rationale for a promising intervention: enhancing cognition to prevent mobility decline and reduce risk of falls. The long-term goal is to create a clinical research program to apply rTMS as an early novel intervention for cognitive/motor interaction to ultimately delay the onset of cognitive and mobility disabilities and their devastating consequences, dementia and falls, in older adults. However, it is first necessary to study a smaller group of seniors to plan for recruitment, study retention and compliance, and to gather preliminary data as proof of principle before proceeding to a larger clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS Active | Experimental | Device: Magstim® Rapid 2 machineHigh frequency pulsed repetitive magnetic stimulation at 100 % resting motor threshold will be delivered using a figure of 8 air film cooled coil attached to the Magstim® Rapid 2 machine. Resting motor threshold will be determined minimum energy needed to elicit the a reliable visible contraction in the contra-lateral first interosseous muscle using single pulse rTMS applied to the area between C1-C3 using the 10-20 international EEG electrode system. For stimulation, the coil will be positioned on the scalp corresponding to F4 then F3 electrode position using the 10-20 international EEG system. Real stimulation will consist of delivering 1200 pulses at 20 hz frequency to F4 location followed by the same stimulation to F3. The total time needed to deliver pulses is 20 minutes. |
| rTMS Sham | Placebo comparator | Device: Magstim® Rapid 2 machineSham stimulation will also involve delivering the same stimulus but with angulation of the coil at 45 degrees, which will give similar scalp sensation but unlikely to deliver magnetic stimulation to the cortex |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having executive dysfunction (defined as score below 11 out of a possible 13 in the "Montreal Cognitive Assessment -MoCA- executive score index")
- Age 60 years and older
- English speaking
- Able to ambulate 10m independently without any gait aid (eg. walker, cane)
Key exclusion criteria (11 listed)
- Unable to understand or communicate in English
- Parkinsonism or any neurological disorder with residual motor deficit (eg. Major stroke, epilepsy)
- Musculoskeletal disorder detected by clinical examination which affects gait performance -Active osteoarthritis affecting lower limbs (American College of Rheumatology criteria)
- Severe depression operationalized as Geriatric Depression Scale (GDS) score>10
- Persons with metal anywhere in the head, excluding the mouth, including shrapnel, and screws and clips from surgical procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magstim® Rapid 2 machineAlso: MAGSTIM® RAPID II SYSTEM License number 69773See Arms description | Device | rTMS Active, rTMS Sham |
Primary outcome
Gait velocity - cm/s
Time frame: Seven days
1 secondary outcome
Executive function, assessed as time to take to complete Trail Making A and B (TMT A and B) in seconds.
Time frame: seven days
Results and safety
The study was stopped early (reason given: Unforeseen challenges that rendered Recruitment more challenging than expected. Thus, recruitment is terminated earlier to proceed with data analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 23110433Montero-Odasso M, Verghese J, Beauchet O, Hausdorff JM. Gait and cognition: a complementary approach to understanding brain function and the risk of falling. J Am Geriatr Soc. 2012 Nov;60(11):2127-36. doi: 10.1111/j.1532-5415.2012.04209.x. Epub 2012 Oct 30.
- Background: PubMed 24366243Montero-Odasso M, Hachinski V. Preludes to brain failure: executive dysfunction and gait disturbances. Neurol Sci. 2014 Apr;35(4):601-4. doi: 10.1007/s10072-013-1613-4. Epub 2013 Dec 24.
- Background: PubMed 17557130Shaw FE. Prevention of falls in older people with dementia. J Neural Transm (Vienna). 2007;114(10):1259-64. doi: 10.1007/s00702-007-0741-5. Epub 2007 Jun 8.
- Background: PubMed 17158580Oliver D, Connelly JB, Victor CR, Shaw FE, Whitehead A, Genc Y, Vanoli A, Martin FC, Gosney MA. Strategies to prevent falls and fractures in hospitals and care homes and effect of cognitive impairment: systematic review and meta-analyses. BMJ. 2007 Jan 13;334(7584):82. doi: 10.1136/bmj.39049.706493.55. Epub 2006 Dec 8.
- Background: PubMed 12521968Shaw FE, Bond J, Richardson DA, Dawson P, Steen IN, McKeith IG, Kenny RA. Multifactorial intervention after a fall in older people with cognitive impairment and dementia presenting to the accident and emergency department: randomised controlled trial. BMJ. 2003 Jan 11;326(7380):73. doi: 10.1136/bmj.326.7380.73.
- Background: PubMed 22579164Connolly KR, Helmer A, Cristancho MA, Cristancho P, O'Reardon JP. Effectiveness of transcranial magnetic stimulation in clinical practice post-FDA approval in the United States: results observed with the first 100 consecutive cases of depression at an academic medical center. J Clin Psychiatry. 2012 Apr;73(4):e567-73. doi: 10.4088/JCP.11m07413.
- Background: PubMed 19833552Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
- Background: PubMed 21511208Andrews SC, Hoy KE, Enticott PG, Daskalakis ZJ, Fitzgerald PB. Improving working memory: the effect of combining cognitive activity and anodal transcranial direct current stimulation to the left dorsolateral prefrontal cortex. Brain Stimul. 2011 Apr;4(2):84-9. doi: 10.1016/j.brs.2010.06.004. Epub 2010 Jul 11.
- Background: PubMed 15999258Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.
- Background: PubMed 17113573Luber B, Kinnunen LH, Rakitin BC, Ellsasser R, Stern Y, Lisanby SH. Facilitation of performance in a working memory task with rTMS stimulation of the precuneus: frequency- and time-dependent effects. Brain Res. 2007 Jan 12;1128(1):120-9. doi: 10.1016/j.brainres.2006.10.011. Epub 2006 Nov 20.
- Background: PubMed 23039931Barr MS, Farzan F, Rajji TK, Voineskos AN, Blumberger DM, Arenovich T, Fitzgerald PB, Daskalakis ZJ. Can repetitive magnetic stimulation improve cognition in schizophrenia? Pilot data from a randomized controlled trial. Biol Psychiatry. 2013 Mar 15;73(6):510-7. doi: 10.1016/j.biopsych.2012.08.020. Epub 2012 Oct 3.
- Background: PubMed 25179996Doruk D, Gray Z, Bravo GL, Pascual-Leone A, Fregni F. Effects of tDCS on executive function in Parkinson's disease. Neurosci Lett. 2014 Oct 17;582:27-31. doi: 10.1016/j.neulet.2014.08.043. Epub 2014 Aug 30.
- Individual participant dataSharing planned: No. Due to the proof of principle nature of this study, our data will be crucial to establish efficacy of the intervention and furhet apply for funding for larger, clinical trial to test efectiveness
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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.
Manuel Montero Odasso, MD,PhD principal investigator
Lawson Health Research Institute, Western University, St. Joseph's Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magstim® Rapid 2 machine in people with Executive Dysfunction and Gait Performance, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 8 Mar 2024. 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 Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unforeseen challenges that rendered Recruitment more challenging than expected. Thus, recruitment is terminated earlier to proceed with data analysis.). Results are not available in the source record.
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?
Gait velocity - cm/s (time frame: Seven days). 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 NCT02740530, which also lists 23 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 8 Mar 2024.