PTSDNCT06813378
(Neuro)Cognitive Remediation for Adults With OSIs
A study testing (Neuro)Cognitive Remediation in people with PTSD and Cognitive Impairment, run by Nova Scotia Health Authority.
Trial summary
(Neuro)Cognitive remediation (CR) is an intervention for people experiencing cognitive impairments that interfere with their daily functioning. Cognition refers to a person's ability to perceive, process, manipulate and respond to information. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Cognitive Impairment, Cognitive Dysfunction
- What is being tested?
- (Neuro)Cognitive Remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be:
- Clients engaging in treatment at the Nova Scotia OSI Clinic who may benefit from the CR program.
- Be experiencing cognitive challenges which may be improved through the cognitive remediation program, as determined by the treating Occupational Therapist.
Who cannot join
- Participants must not:
- -Be accessing CR treatment modality through an Occupational Therapist
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: (Neuro)Cognitive Remediation for Adults With Operational Stress Injuries
(Neuro)Cognitive remediation (CR) is an intervention for people experiencing cognitive impairments that interfere with their daily functioning. Cognition refers to a person's ability to perceive, process, manipulate and respond to information. Attention, memory, abstract reasoning, and processing speed are all examples of cognitive skills. By focusing on improving these underlying skills, the overall aim of cognitive remediation is to improve the participant's daily satisfaction and success. CR can be achieved through teaching compensatory strategies, restoration of cognition through drill and practice and by utilizing regulative metacognitive strategies. Acquired skills and strategies are then 'bridged' or applied to daily functioning with the assistance of the clinician.
This pilot study intends to assess the impacts of a CR program on a population of Military Veterans, police officers, and retirees within the Nova Scotia Operational Stress Injury Clinic (NSOSIC). Researchers believe this program will improve cognitive functioning and that participants will perceive that the program was beneficial.
Read the detailed description
CR is used in many client populations including acquired brain injury (ABI) , attention deficit hyperactivity disorder (ADHD) and post-traumatic stress disorder (PTSD) . Research has begun a more in-depth exploration into the relationship between psychological diagnoses and cognitive impairments. Difficulties in memory, attention, problem- solving ability, and processing speed have been linked to many mental health diagnoses which results in occupational dysfunction in the areas of daily routine, self-care, productivity, leisure, and relationships. Addressing these cognitive impairments with cognitive remediation can be an important step alongside other therapies in the recovery process.
Although CR programs and strategies have been studied with the populations referenced above, it has not been sufficiently evaluated from a mental health trans-diagnostic perspective for military Veterans and police officers and retirees. Additionally, the particular a combination of compensatory, restorative and regulative cognitive remediation used in the CR program for this research has not been published about for this clinical population that has cognitive impairments, but has been used with other populations of mental health service users .
Qualitative research methods will be the focus of this pilot study as they can provide a detailed understanding of the lived experiences of individuals using a relatively small sample size. Using qualitative research methodologies is also advantageous to answer the current research question as it allows participants to share experiences from their own point of view, rather than relying on the pre-suppositions of researchers, as would likely need to be done if trying to use quantitative research methods. Qualitative data will be obtained through individual semi-structured interviews with all participants of this study. These individual interviews will result in complete transcripts of conversations which can be thoroughly analyzed by researchers. This research will use an interpretive phenomenology framework for analysis, as will be described in the data analysis phase of this document.
Quantitative research methodologies will also be used within this pilot study. Four different psychometric measures will be completed by participants at the start and end of this study:
- Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)- a standardized assessment to screen for cognitive functioning which covers 5 domains: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory.
- World Health Organization Disability Assessment Schedule 2.0 (WHODAS)- a standardized assessment measuring health and disability across cultures which covers 6 domains: cognition, mobility, self-care, getting along, life activities, and participation.
- Patient Health Questionnaire 9 Item (PHQ-9)- A 9-item screening tool used to assess the severity of depression-related symptoms.
- Generalized Anxiety Disorder 7 Item (GAD-7)- a 7-item screening tool used to assess the severity of anxiety-related symptoms.
- Conditions
- PTSD, Cognitive Impairment, Cognitive Dysfunction
- Being tested
- (Neuro)Cognitive Remediation
- Keywords
- PTSD, Military, Veteran, Cognitive Remediation
- Medical subject headings
- Stress Disorders, Post-Traumatic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Neuro)Cognitive RemediationBehavioural
(Neuro)Cognitive remediation is an intervention for people experiencing cognitive impairments that interfere with their daily functioning. Attention, memory, abstract reasoning, and processing speed are all examples of cognitive skills. By focusing on improving these underlying skills, the overall aim of cognitive remediation is to improve the client's daily satisfaction and success. Although cognitive remediation programs and strategies have been studied with other populations, it has not been sufficiently evaluated from a mental health trans-diagnostic perspective for military Veterans and police officers and retirees who this research will study.
| Study group | Role | What they receive |
|---|---|---|
| (Neuro)Cognitive Remediation | Experimental | Participants will undergo structured cognitive remediation program under the supervision of an Occupational Therapist. (Neuro)Cognitive Remediation will be achieved through teaching compensatory strategies, restoration of cognition through drill and practice and by utilizing regulative metacognitive strategies. Receives: Behavioral: (Neuro)Cognitive Remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Reported Qualitative Experience
Qualitative data will be obtained through individual semi-structured interviews with all participants of this study. These individual interviews will result in complete transcripts of conversations which can be thoroughly analyzed by researchers. This research will use an interpretive phenomenology framework for analysis, as will be described in the data analysis phase of this document.
Measured: From enrollment to the end of treatment- up to 17 weeks after enrollment.
Secondary outcomes (5)
1. Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)
A standardized assessment to screen for cognitive functioning which covers 5 domains: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory. Total scale scores can range from 40-160, with lower scores indicating a worse outcome.
Measured: From enrollment to the end of treatment- up to 17 weeks after enrollment.
World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
A standardized assessment measuring health and disability across cultures which covers 6 domains: cognition, mobility, self-care, getting along, life activities, and participation. Scores on this measure can range from 0-48, with higher scores representing a worse outcome.
Measured: From enrollment to the end of treatment- up to 17 weeks after enrollment.
Patient Health Questionnaire 9 Item (PHQ-9)
A 9-item screening tool used to assess the severity of depression-related symptoms. Scores range from 0-27 with higher scores indicating higher levels of distress.
Measured: From enrollment to the end of treatment- up to 17 weeks after enrollment.
Generalized Anxiety Disorder 7 Item (GAD-7)
A 7-item screening tool used to assess the severity of anxiety-related symptoms. Scores range from 0-21 with higher scores indicating higher levels of distress.
Measured: From enrollment to the end of treatment- up to 17 weeks after enrollment.
Montreal Cognitive Assessment
a questionnaire administered by a trained clinician used to detect mild cognitive impairments with lower scores indicating cognitive impairment.
Measured: From enrollment to the end of treatment- up to 17 weeks after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- 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
- Model description
- Participants will complete a minimum of 5 and a maximum of 17 one-on-one sessions (1-1.5 hrs in length) with an Occupational Therapist throughout the CR program. This program is designed to be tailored to a participant's individual needs, focusing on their specific cognitive impairments (hence the large range of potential sessions). During these sessions, participants will work with their clinician to learn compensatory strategies and restoration of cognition through a series of drill and practices to overcome their cognitive challenges. This study will use a mixed methods design incorporating both qualitative and quantitative research methods. Upon completion of the program, participants will be asked to complete a one-on-one interview with a researcher lasting approximately one hour. Additionally, participants will complete two psychometric questionnaires before beginning the cognitive remediation program and upon completion of the program.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abraham Rudnick, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813378
- Sponsor's protocol ID
- 65194
- Status last verified
- Jun 2025
- First submitted
- 31 Jan 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Best MW, Bowie CR. A review of cognitive remediation approaches for schizophrenia: from top-down to bottom-up, brain training to psychotherapy. Expert Rev Neurother. 2017 Jul;17(7):713-723. doi: 10.1080/14737175.2017.1331128. Epub 2017 May 24.
PubMed 28511562Fonzo GA, Fine NB, Wright RN, Achituv M, Zaiko YV, Merin O, Shalev AY, Etkin A. Internet-delivered computerized cognitive & affective remediation training for the treatment of acute and chronic posttraumatic stress disorder: Two randomized clinical trials. J Psychiatr Res. 2019 Aug;115:82-89. doi: 10.1016/j.jpsychires.2019.05.007. Epub 2019 May 8.
PubMed 31125916McClure MM, Graff FS, Triebwasser J, Perez-Rodriguez MM, Rosell DR, Szeszko PR, Chu KW, New AS, Siever LJ, Hazlett EA. Neuroimaging predictors of response to cognitive remediation and social skills training: A pilot study in veterans with schizophrenia. Psychiatry Res Neuroimaging. 2019 Nov 30;293:110988. doi: 10.1016/j.pscychresns.2019.110988. Epub 2019 Oct 8.
PubMed 31655369Randolph C, Tierney MC, Mohr E, Chase TN. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 1998 Jun;20(3):310-9. doi: 10.1076/jcen.20.3.310.823.
PubMed 9845158Stevenson CS, Whitmont S, Bornholt L, Livesey D, Stevenson RJ. A cognitive remediation programme for adults with Attention Deficit Hyperactivity Disorder. Aust N Z J Psychiatry. 2002 Oct;36(5):610-6. doi: 10.1046/j.1440-1614.2002.01052.x.
PubMed 12225443Twamley EW, Jak AJ, Delis DC, Bondi MW, Lohr JB. Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) for veterans with traumatic brain injury: pilot randomized controlled trial. J Rehabil Res Dev. 2014;51(1):59-70. doi: 10.1682/JRRD.2013.01.0020.
PubMed 24805894Vanderploeg RD, Cooper DB, Curtiss G, Kennedy JE, Tate DF, Bowles AO. Predicting treatment response to cognitive rehabilitation in military service members with mild traumatic brain injury. Rehabil Psychol. 2018 May;63(2):194-204. doi: 10.1037/rep0000215.
PubMed 29878826
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Neuro)Cognitive Remediation for Adults With Operational Stress Injuries
- ClinicalTrials.gov ID
- NCT06813378
- Acronym / sponsor ID
- 65194
- Conditions
- PTSD, Cognitive Impairment, Cognitive Dysfunction
- Keywords
- PTSD, Military, Veteran, Cognitive Remediation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Feb 2025 (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.
(Neuro)Cognitive remediation (CR) is an intervention for people experiencing cognitive impairments that interfere with their daily functioning. Cognition refers to a person's ability to perceive, process, manipulate and respond to information. Attention, memory, abstract reasoning, and processing speed are all examples of cognitive skills. By focusing on improving these underlying skills, the overall aim of cognitive remediation is to improve the participant's daily satisfaction and success. CR can be achieved through teaching compensatory strategies, restoration of cognition through drill and practice and by utilizing regulative metacognitive strategies. Acquired skills and strategies are then 'bridged' or applied to daily functioning with the assistance of the clinician.
This pilot study intends to assess the impacts of a CR program on a population of Military Veterans, police officers, and retirees within the Nova Scotia Operational Stress Injury Clinic (NSOSIC). Researchers believe this program will improve cognitive functioning and that participants will perceive that the program was beneficial.
Detailed description
CR is used in many client populations including acquired brain injury (ABI) , attention deficit hyperactivity disorder (ADHD) and post-traumatic stress disorder (PTSD) . Research has begun a more in-depth exploration into the relationship between psychological diagnoses and cognitive impairments. Difficulties in memory, attention, problem- solving ability, and processing speed have been linked to many mental health diagnoses which results in occupational dysfunction in the areas of daily routine, self-care, productivity, leisure, and relationships. Addressing these cognitive impairments with cognitive remediation can be an important step alongside other therapies in the recovery process.
Although CR programs and strategies have been studied with the populations referenced above, it has not been sufficiently evaluated from a mental health trans-diagnostic perspective for military Veterans and police officers and retirees. Additionally, the particular a combination of compensatory, restorative and regulative cognitive remediation used in the CR program for this research has not been published about for this clinical population that has cognitive impairments, but has been used with other populations of mental health service users .
Qualitative research methods will be the focus of this pilot study as they can provide a detailed understanding of the lived experiences of individuals using a relatively small sample size. Using qualitative research methodologies is also advantageous to answer the current research question as it allows participants to share experiences from their own point of view, rather than relying on the pre-suppositions of researchers, as would likely need to be done if trying to use quantitative research methods. Qualitative data will be obtained through individual semi-structured interviews with all participants of this study. These individual interviews will result in complete transcripts of conversations which can be thoroughly analyzed by researchers. This research will use an interpretive phenomenology framework for analysis, as will be described in the data analysis phase of this document.
Quantitative research methodologies will also be used within this pilot study. Four different psychometric measures will be completed by participants at the start and end of this study:
- Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)- a standardized assessment to screen for cognitive functioning which covers 5 domains: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory.
- World Health Organization Disability Assessment Schedule 2.0 (WHODAS)- a standardized assessment measuring health and disability across cultures which covers 6 domains: cognition, mobility, self-care, getting along, life activities, and participation.
- Patient Health Questionnaire 9 Item (PHQ-9)- A 9-item screening tool used to assess the severity of depression-related symptoms.
- Generalized Anxiety Disorder 7 Item (GAD-7)- a 7-item screening tool used to assess the severity of anxiety-related symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will complete a minimum of 5 and a maximum of 17 one-on-one sessions (1-1.5 hrs in length) with an Occupational Therapist throughout the CR program. This program is designed to be tailored to a participant's individual needs, focusing on their specific cognitive impairments (hence the large range of potential sessions). During these sessions, participants will work with their clinician to learn compensatory strategies and restoration of cognition through a series of drill and practices to overcome their cognitive challenges. This study will use a mixed methods design incorporating both qualitative and quantitative research methods. Upon completion of the program, participants will be asked to complete a one-on-one interview with a researcher lasting approximately one hour. Additionally, participants will complete two psychometric questionnaires before beginning the cognitive remediation program and upon completion of the program.
| Arm | Type | Receives |
|---|---|---|
| (Neuro)Cognitive Remediation | Experimental | Behavioral: (Neuro)Cognitive RemediationParticipants will undergo structured cognitive remediation program under the supervision of an Occupational Therapist. (Neuro)Cognitive Remediation will be achieved through teaching compensatory strategies, restoration of cognition through drill and practice and by utilizing regulative metacognitive strategies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clients engaging in treatment at the Nova Scotia OSI Clinic who may benefit from the CR program.
- Be experiencing cognitive challenges which may be improved through the cognitive remediation program, as determined by the treating Occupational Therapist.
Key exclusion criteria (2 listed)
- -Be accessing CR treatment modality through an Occupational Therapist
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 |
|---|---|---|
| (Neuro)Cognitive Remediation(Neuro)Cognitive remediation is an intervention for people experiencing cognitive impairments that interfere with their daily functioning. Attention, memory, abstract reasoning, and processing speed are all examples of cognitive skills. By focusing on improving these underlying skills, the overall aim of cognitive remediation is to improve the client's daily satisfaction and success. Although cognitive remediation programs and strategies have been studied with other populations, it has not been sufficiently evaluated from a mental health trans-diagnostic perspective for military Veterans and police officers and retirees who this research will study. | Behavioural | (Neuro)Cognitive Remediation |
Primary outcome
Participant Reported Qualitative Experience
Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.
Qualitative data will be obtained through individual semi-structured interviews with all participants of this study. These individual interviews will result in complete transcripts of conversations which can be thoroughly analyzed by researchers. This research will use an interpretive phenomenology framework for analysis, as will be described in the data analysis phase of this document.
5 secondary outcomes
1. Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)
Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.
World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.
Patient Health Questionnaire 9 Item (PHQ-9)
Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.
Generalized Anxiety Disorder 7 Item (GAD-7)
Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.
Montreal Cognitive Assessment
Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.
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 8 Jun 2025.
- Background: PubMed 28511562Best MW, Bowie CR. A review of cognitive remediation approaches for schizophrenia: from top-down to bottom-up, brain training to psychotherapy. Expert Rev Neurother. 2017 Jul;17(7):713-723. doi: 10.1080/14737175.2017.1331128. Epub 2017 May 24.
- Background: PubMed 31125916Fonzo GA, Fine NB, Wright RN, Achituv M, Zaiko YV, Merin O, Shalev AY, Etkin A. Internet-delivered computerized cognitive & affective remediation training for the treatment of acute and chronic posttraumatic stress disorder: Two randomized clinical trials. J Psychiatr Res. 2019 Aug;115:82-89. doi: 10.1016/j.jpsychires.2019.05.007. Epub 2019 May 8.
- Background: PubMed 31655369McClure MM, Graff FS, Triebwasser J, Perez-Rodriguez MM, Rosell DR, Szeszko PR, Chu KW, New AS, Siever LJ, Hazlett EA. Neuroimaging predictors of response to cognitive remediation and social skills training: A pilot study in veterans with schizophrenia. Psychiatry Res Neuroimaging. 2019 Nov 30;293:110988. doi: 10.1016/j.pscychresns.2019.110988. Epub 2019 Oct 8.
- Background: PubMed 9845158Randolph C, Tierney MC, Mohr E, Chase TN. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 1998 Jun;20(3):310-9. doi: 10.1076/jcen.20.3.310.823.
- Background: PubMed 12225443Stevenson CS, Whitmont S, Bornholt L, Livesey D, Stevenson RJ. A cognitive remediation programme for adults with Attention Deficit Hyperactivity Disorder. Aust N Z J Psychiatry. 2002 Oct;36(5):610-6. doi: 10.1046/j.1440-1614.2002.01052.x.
- Background: PubMed 24805894Twamley EW, Jak AJ, Delis DC, Bondi MW, Lohr JB. Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) for veterans with traumatic brain injury: pilot randomized controlled trial. J Rehabil Res Dev. 2014;51(1):59-70. doi: 10.1682/JRRD.2013.01.0020.
- Background: PubMed 29878826Vanderploeg RD, Cooper DB, Curtiss G, Kennedy JE, Tate DF, Bowles AO. Predicting treatment response to cognitive rehabilitation in military service members with mild traumatic brain injury. Rehabil Psychol. 2018 May;63(2):194-204. doi: 10.1037/rep0000215.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing (Neuro)Cognitive Remediation in people with PTSD and Cognitive Impairment, run by Nova Scotia Health Authority.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 8 Jun 2025. 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?
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?
Contact Abraham Rudnick, MD, PhD, MPsych, BMedSc (902-460-6225, abraham.rudnick@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Reported Qualitative Experience (time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.). 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 NCT06813378, which also lists 7 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 Jun 2025.