AgingNCT04732533
Feasibility of Home-based tES for Older Adults at Risk of Falling
A study testing tES (transcranial electrical stimulation) in people with Aging and Accidental Falls, run by Hebrew SeniorLife at 1 site in United States.
Trial summary
In this project, the investigators propose to demonstrate the feasibility of remotely-monitored, caregiver (or spouse)-administered, home-based tES (transcranial electrical stimulation) intervention to improve mobility in ambulatory older adults with recent falls. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Accidental Falls
- What is being tested?
- tES (transcranial electrical stimulation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Inclusion criteria will be the same for PF/PA pairs in both Phase 1 and Phase 2 of the study. All participant pairs who complete either Phase 1 or 2 will be eligible to complete Phase 3. All participant teams who complete Phase 3 in its entirety will be eligible to complete Phase 4
- PF group:
- Aged 60+
- Self-report of one or more falls within the past year, and/or concern of falling in the future, and/or self-report of Parkinson's disease.
- Able to read, write, and communicate in English
- Able to identify an eligible PA to participate with them in the study
Show all 11Show fewer
- PA group:
- At least 21 years of age
- Able to read, write, and communicate in English
- Self-reported computer proficiency and willingness to learn how to use tDCS
- Stated availability during weekdays throughout the study period to administer tDCS to the PF
Who cannot join
- Exclusion criteria will be the same for PF/PA pairs in both Phase 1 and Phase 2 of the study.
- PF group:
- Evidence of cognitive impairment that would likely interfere with one's ability to understand the study protocol, risks/benefits, and testing procedures. This will be defined as self-reported diagnosis of Alzheimer's disease or dementia, a score of ≤19 on the Telephone Interview for Cognitive Status (TICS) at the time of telephone screening, a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen, or an inability to understand study procedures following review of the Informed Consent form.
- Inability to stand or ambulate unassisted for at least 25 feet.
- Contraindications to tDCS, including a reported seizure within the past two years, use of neuro-active drugs, the risk of metal objects in the brain, skull, or head, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant), or the presence of any active, uncontrolled dermatological condition, such as eczema, on the scalp.
- PA group:
- Mild cognitive impairment defined by a TICS score ≤34 during the phone screen, a MoCA score ≤24 during the in-person screen, or insufficient understanding of study procedures following review of the Informed Consent form.
- Poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tDCS.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hebrew Rehabilitation Center
Roslindale, Massachusetts, 02131
About this study
In this project, the investigators propose to demonstrate the feasibility of remotely-monitored, caregiver (or spouse)-administered, home-based tES (transcranial electrical stimulation) intervention to improve mobility in ambulatory older adults with recent falls. This is a four-phase feasibility study in older, ambulatory adult participants at risk of falling due to a loss of balance (participant faller, PF) together with a willing and able participant administrator (PA) that is available during weekdays to administer tES to the PF.
Phase 1 is focused on the development and refinement of our training materials for home-based tDCS (transcranial direct current stimulation) for PF/PA pairs. The objectives of this phase:
Read more
- Identify areas of confusion and challenges for older adults.
- Refine our training materials to accompany the home-based tDCS system.
In Phase 2, the investigators will complete a pilot trial in 12 PF/PA pairs to assess the feasibility of deploying home-based tES in larger clinical trials, and to prepare for the development and implementation of such trials. The objectives of this phase:
- Determine the mean/range number of visits needed for in-person training.
- Compliance and retention with the study protocol.
- Safety/side effects of home-based tES, as compared to previously established laboratory-based tES data.
The investigators hypothesize that adult PAs are able to successfully administer home-based tES to PFs. The investigators also expect that PF/PA pairs will exhibit excellent adherence to the intervention and that the prevalence and severity of reported tDCS side-effects will be similar to that observed in previous laboratory-based studies.
In Phase 3, the investigators will complete a pilot trial in up to 18 PF/PA pairs; i.e., those who have previously successfully completed either Phase 1 or Phase 2. The study objectives/aims for Phase 3 are:
- Further explore compliance and retention with the study protocol over a longer time period
- Identify safety/side effects of home-based tES over a longer time-period as compared to previously established laboratory-based tDCS interventions.
In Phase 3, the investigators hypothesize that adult PA's who have previously demonstrated the ability to successfully administer tES at home, will retain competence and compliance with administration over a longer period, up to 1 year.
In Phase 4, we will complete a pilot trial in up to 18 PF/PA teams; those who have previously successfully completed Phase 3. The study objective/aims for Phase 4 will be to:
- Identify Safety, effectiveness and adherence to home-based tES over longer period of time as compared to previously established laboratory-based tES interventions.
- Further explore the proof of Concept for the home-based tES interventions
In Phase 4 we hypothesize that adult PA's who have previously demonstrated the ability to successfully administer tES at home, will adhere with the study protocol over a longer period of time, up to 3 years.
Read the detailed description
In older adults, falls are costly, consequential and correlated with both physical and cognitive decline. Most falls occur when standing or walking, especially when completing these tasks in complex environments or while simultaneously performing additional cognitive tasks. To this end, older adults with worse cognitive "executive" function have worse mobility and are more likely to fall.
Transcranial Electrical Stimulation (tES), which includes both transcranial Direct Current Stimulation (tDCS) and transcranial Alternating Current Stimulation (tACS), holds promise as a therapy to improve dual task standing and walking and other "high-level" aspects of mobility in older adults. tES is a low cost technique, is very safe with only minimal side effects, is portable and is very easy to administer. However, tES must be administered numerous times per week for several consecutive weeks in order to induce lasting therapeutic benefit. As each tES session must currently be administered in clinical or laboratory settings, such interventions are not currently available to many older adults--especially those who 1) live far away from the clinical/laboratory, and/or 2) have physical and/or cognitive limitations that make it difficult to organize and utilize transportation.
- Conditions
- Aging, Accidental Falls
- Being tested
- tES (transcranial electrical stimulation)
- Keywords
- Mobility, Dual Task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tES (transcranial electrical stimulation)Other
Phase 1: The participant will receive 10, 20-minute sessions of tDCS on Monday-Friday, at approximately the same time of day, over two consecutive weeks.
Phase 2: The participant will receive 22, 20-minute sessions of tES. 10 sessions will take place over the first two weeks on Monday-Friday, at approximately the same time of day. This will be followed by 3 tES sessions per week over four weeks.
Phase 3: The participant will receive up to 260, 20-minute sessions of tES. The participant can complete up to 5 tDCS sessions per week over 52 weeks.
Phase 4: The participant will receive up to 780, 20-minute sessions of tES. The participant can complete up to 5 tDCS sessions per week over 156 weeks.
| Study group | Role | What they receive |
|---|---|---|
| tES (transcranial electrical stimulation) | Experimental | All participants in phase 1 received the tDCS (transcranial direct current stimulation) intervention. For each new potential participant recruited into Phase 2, 3 or 4, the type of tES intervention, either tDCS or a combination of tDCS and tACS (transcranial alternating current stimulation) will be determined at the discretion of the study PI in consultation with the participant.
The tDCS intervention will be administered with the goal of facilitating the excitability of the left dlPFC (dorsolateral prefrontal cortex).
The combination of tDCS and tACS intervention will be administered with the goals of 1) using tDCS to facilitate the excitability of the left dlPFC using the parameters outlined in the preceding paragraph, and at the same time, 2) using tACS targeting the left angular gyrus at gamma frequency 40 Hz. Receives: Other: tES (transcranial electrical stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening to enrollment ratio ("percent", 0-100, higher ratio means a better outcome)
The number of screenings needed to enroll one participant
Measured: The whole data collection period of phase 2 (~ 6 weeks for the whole study)
Intervention adherence rate ("percent", 0-100, higher ratio means a better outcome)
Number of tDCS sessions completed
Measured: The whole data collection period (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
Side effects
The number, type, severity and duration of reported side effects
Measured: The whole data collection period (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
Training sessions
The number of training sessions needed for PAs to successfully and comfortably administer home-based tDCS
Measured: The whole data collection period (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
Secondary outcomes (6)
Change from baseline in the dual task cost to gait speed (reduced dual task cost after intervention means a better outcome)
The change from baseline in the degree to which performing a secondary cognitive task diminishes gait speed
Measured: The whole data collection period (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
Change from baseline in the dual task cost to standing postural sway speed (reduced dual task cost after intervention means a better outcome)
The change from baseline in the degree to which performing a secondary cognitive task diminishes the control of standing posture.
Measured: Before and after the intervention (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
Change from baseline in Trail Making Test B - A (reduced time after intervention means a better outcome)
The change from baseline in cognitive executive function
Measured: Before and after the intervention (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
Change from baseline in gait speed (increased value after intervention means a better outcome)
The change from baseline in gait speed
Measured: Before and after the intervention (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
Change from baseline in Timed Up-and-Go (TUG) (reduced time after intervention means a better outcome)
The change from baseline in overall mobility function
Measured: Before and after the intervention (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
Change from baseline in Montreal Cognitive Assessment (MoCA) total score (increased score after intervention means a better outcome)
The change from baseline in global cognitive function
Measured: Before and after the intervention (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start25 Jan 2021
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, open-label intervention.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brad Manor, PhD, Principal investigator, Hebrew SeniorLife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732533
- Sponsor's protocol ID
- 2018-16
- Other IDs
- Pro00044339
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2021
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The HSL Institute for Aging Research will promote the development of new research and new investigators by making the data available to outside investigators. The database will include longitudinal demographic, clinical, functional, and physiologic from all participants. All data will be stripped of primary identifiers and entered into a master database. All data collection procedures, variable definitions and codes, field locations, and frequencies will be documented in a separate file.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Home-based tES for Older Adults at Risk of Falling
- ClinicalTrials.gov ID
- NCT04732533
- Acronym / sponsor ID
- 2018-16
- Conditions
- Aging, Accidental Falls
- Keywords
- Mobility, Dual Task
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 1 Feb 2021 (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.
In this project, the investigators propose to demonstrate the feasibility of remotely-monitored, caregiver (or spouse)-administered, home-based tES (transcranial electrical stimulation) intervention to improve mobility in ambulatory older adults with recent falls. This is a four-phase feasibility study in older, ambulatory adult participants at risk of falling due to a loss of balance (participant faller, PF) together with a willing and able participant administrator (PA) that is available during weekdays to administer tES to the PF.
Phase 1 is focused on the development and refinement of our training materials for home-based tDCS (transcranial direct current stimulation) for PF/PA pairs. The objectives of this phase:
- Identify areas of confusion and challenges for older adults.
- Refine our training materials to accompany the home-based tDCS system.
In Phase 2, the investigators will complete a pilot trial in 12 PF/PA pairs to assess the feasibility of deploying home-based tES in larger clinical trials, and to prepare for the development and implementation of such trials. The objectives of this phase:
- Determine the mean/range number of visits needed for in-person training.
- Compliance and retention with the study protocol.
- Safety/side effects of home-based tES, as compared to previously established laboratory-based tES data.
The investigators hypothesize that adult PAs are able to successfully administer home-based tES to PFs. The investigators also expect that PF/PA pairs will exhibit excellent adherence to the intervention and that the prevalence and severity of reported tDCS side-effects will be similar to that observed in previous laboratory-based studies.
In Phase 3, the investigators will complete a pilot trial in up to 18 PF/PA pairs; i.e., those who have previously successfully completed either Phase 1 or Phase 2. The study objectives/aims for Phase 3 are:
- Further explore compliance and retention with the study protocol over a longer time period
- Identify safety/side effects of home-based tES over a longer time-period as compared to previously established laboratory-based tDCS interventions.
In Phase 3, the investigators hypothesize that adult PA's who have previously demonstrated the ability to successfully administer tES at home, will retain competence and compliance with administration over a longer period, up to 1 year.
In Phase 4, we will complete a pilot trial in up to 18 PF/PA teams; those who have previously successfully completed Phase 3. The study objective/aims for Phase 4 will be to:
- Identify Safety, effectiveness and adherence to home-based tES over longer period of time as compared to previously established laboratory-based tES interventions.
- Further explore the proof of Concept for the home-based tES interventions
In Phase 4 we hypothesize that adult PA's who have previously demonstrated the ability to successfully administer tES at home, will adhere with the study protocol over a longer period of time, up to 3 years.
Detailed description
In older adults, falls are costly, consequential and correlated with both physical and cognitive decline. Most falls occur when standing or walking, especially when completing these tasks in complex environments or while simultaneously performing additional cognitive tasks. To this end, older adults with worse cognitive "executive" function have worse mobility and are more likely to fall.
Transcranial Electrical Stimulation (tES), which includes both transcranial Direct Current Stimulation (tDCS) and transcranial Alternating Current Stimulation (tACS), holds promise as a therapy to improve dual task standing and walking and other "high-level" aspects of mobility in older adults. tES is a low cost technique, is very safe with only minimal side effects, is portable and is very easy to administer. However, tES must be administered numerous times per week for several consecutive weeks in order to induce lasting therapeutic benefit. As each tES session must currently be administered in clinical or laboratory settings, such interventions are not currently available to many older adults--especially those who 1) live far away from the clinical/laboratory, and/or 2) have physical and/or cognitive limitations that make it difficult to organize and utilize transportation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, open-label intervention.
| Arm | Type | Receives |
|---|---|---|
| tES (transcranial electrical stimulation) | Experimental | Other: tES (transcranial electrical stimulation)All participants in phase 1 received the tDCS (transcranial direct current stimulation) intervention. For each new potential participant recruited into Phase 2, 3 or 4, the type of tES intervention, either tDCS or a combination of tDCS and tACS (transcranial alternating current stimulation) will be determined at the discretion of the study PI in consultation with the participant. The tDCS intervention will be administered with the goal of facilitating the excitability of the left dlPFC (dorsolateral prefrontal cortex). The combination of tDCS and tACS intervention will be administered with the goals of 1) using tDCS to facilitate the excitability of the left dlPFC using the parameters outlined in the preceding paragraph, and at the same time, 2) using tACS targeting the left angular gyrus at gamma frequency 40 Hz. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Inclusion criteria will be the same for PF/PA pairs in both Phase 1 and Phase 2 of the study. All participant pairs who complete either Phase 1 or 2 will be eligible to complete Phase 3. All participant teams who complete Phase 3 in its entirety will be eligible to complete Phase 4
- Aged 60+
- Self-report of one or more falls within the past year, and/or concern of falling in the future, and/or self-report of Parkinson's disease.
- Able to read, write, and communicate in English
- Able to identify an eligible PA to participate with them in the study
Key exclusion criteria (8 listed)
- Exclusion criteria will be the same for PF/PA pairs in both Phase 1 and Phase 2 of the study.
- Evidence of cognitive impairment that would likely interfere with one's ability to understand the study protocol, risks/benefits, and testing procedures. This will be defined as self-reported diagnosis of Alzheimer's disease or dementia, a score of ≤19 on the Telephone Interview for Cognitive Status (TICS) at the time of telephone screening, a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen, or an inability to understand study procedures following review of the Informed Consent form.
- Inability to stand or ambulate unassisted for at least 25 feet.
- Contraindications to tDCS, including a reported seizure within the past two years, use of neuro-active drugs, the risk of metal objects in the brain, skull, or head, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant), or the presence of any active, uncontrolled dermatological condition, such as eczema, on the scalp.
- Mild cognitive impairment defined by a TICS score ≤34 during the phone screen, a MoCA score ≤24 during the in-person screen, or insufficient understanding of study procedures following review of the Informed Consent form.
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 |
|---|---|---|
| tES (transcranial electrical stimulation)Phase 1: The participant will receive 10, 20-minute sessions of tDCS on Monday-Friday, at approximately the same time of day, over two consecutive weeks. Phase 2: The participant will receive 22, 20-minute sessions of tES. 10 sessions will take place over the first two weeks on Monday-Friday, at approximately the same time of day. This will be followed by 3 tES sessions per week over four weeks. Phase 3: The participant will receive up to 260, 20-minute sessions of tES. The participant can complete up to 5 tDCS sessions per week over 52 weeks. Phase 4: The participant will receive up to 780, 20-minute sessions of tES. The participant can complete up to 5 tDCS sessions per week over 156 weeks. | Other | tES (transcranial electrical stimulation) |
Primary outcome
Screening to enrollment ratio ("percent", 0-100, higher ratio means a better outcome)
Time frame: The whole data collection period of phase 2 (~ 6 weeks for the whole study)
The number of screenings needed to enroll one participant
Intervention adherence rate ("percent", 0-100, higher ratio means a better outcome)
Time frame: The whole data collection period (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
Number of tDCS sessions completed
Side effects
Time frame: The whole data collection period (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
The number, type, severity and duration of reported side effects
Training sessions
Time frame: The whole data collection period (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
The number of training sessions needed for PAs to successfully and comfortably administer home-based tDCS
6 secondary outcomes
Change from baseline in the dual task cost to gait speed (reduced dual task cost after intervention means a better outcome)
Time frame: The whole data collection period (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
Change from baseline in the dual task cost to standing postural sway speed (reduced dual task cost after intervention means a better outcome)
Time frame: Before and after the intervention (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
Change from baseline in Trail Making Test B - A (reduced time after intervention means a better outcome)
Time frame: Before and after the intervention (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
Change from baseline in gait speed (increased value after intervention means a better outcome)
Time frame: Before and after the intervention (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
Change from baseline in Timed Up-and-Go (TUG) (reduced time after intervention means a better outcome)
Time frame: Before and after the intervention (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
Change from baseline in Montreal Cognitive Assessment (MoCA) total score (increased score after intervention means a better outcome)
Time frame: Before and after the intervention (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Yes. The HSL Institute for Aging Research will promote the development of new research and new investigators by making the data available to outside investigators. The database will include longitudinal demographic, clinical, functional, and physiologic from all participants. All data will be stripped of primary identifiers and entered into a master database. All data collection procedures, variable definitions and codes, field locations, and frequencies will be documented in a separate file.
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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.
Brad Manor, PhD principal investigator
Hebrew SeniorLife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tES (transcranial electrical stimulation) in people with Aging and Accidental Falls, run by Hebrew SeniorLife at 1 site in United States.
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 11 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Screening to enrollment ratio ("percent", 0-100, higher ratio means a better outcome) (time frame: The whole data collection period of phase 2 (~ 6 weeks for the whole study)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.