Passive-Aggressive Personality DisorderBReTIANCT05748808
Use of Biofeedback and Virtual Reality as Facilitators of Emotional Recognition in the Treatment of Aggressive Outbursts
A study testing Use of biofeedback and virtual reality in the treatment of aggressive outbursts in people with Passive-Aggressive Personality Disorder, run by University of Seville at 1 site in Spain.
Trial summary
The methodology will be applied for the treatment of aggressive episodes. Many people show this kind of behavior associated with several psychological disorders like austistic spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Passive-Aggressive Personality Disorder
- What is being tested?
- Use of biofeedback and virtual reality in the treatment of aggressive outbursts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2024to 1 Sep 2025
- 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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Previous diagnosis of ADHD, Asperger syndrome or oppositional defiant disorder (ODD) combined with a lack of control of their aggressiveness.
- Positive impulsivity result obtained with any of the fol- lowing tests: score lower than 25 in CACIA [13], lower than 50 in CAPI-A [14], greater than 75 in Stroop [15] or greater than 115 in WCST [16].
- Intermittent outburst episodes (verbal aggression includ- ing both arguments and temper tantrums, and physical aggression towards self or others) with a frequency of once a week in the two months prior to the beginning of the intervention.
Who cannot join
- Participants will be excluded if they report (a) current (past month) psychopharmacotherapy, (b) a history of bipolar or psychotic disorder, or (c) a traumatic head injury with a loss of consciousness in excess of 60 minutes.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad de Sevilla
Seville, 41012
Isabel M Gomez-Gonzalez, PhD, +34954552787, igomez@us.es
Alberto J Molina-Cantero, PhD, +34954552787, almolina@us.es
About this study
The methodology will be applied for the treatment of aggressive episodes. Many people show this kind of behavior associated with several psychological disorders like austistic spectrum disorder (ASD). It will be studied the effect of aggressive outbursts on several physiological signals (heart rate (HR), breathing rate (BR), electroencephalography (EEG), etc). The use of those signals in a biofeedback loop could help patients recognize their internal states and avoid imminent aggression. The study want to verify the efficacy of a cognitive therapy that includes biofeedback and virtual reality (VR) and find out the most significant physiological features that are affected by these episodes.
Read the detailed description
The first goal is to register the scene together with physiological values before, during and after at least up to four aggressive outbursts at home.
Next an outburst is induced and physiological signals before, during and after the aggressive episode are recorded. After it the participants go to a new relaxation phase for another 10-minute period using the VR.
In following sessions, they are trained to identify their physiological response when they are relaxed and when an outburst is coming. To do that, the VR system receives and shows the physiological information on the virtual scenario.
In following sessions, teenagers are then treated with cognitive, behavioral and emotional self-regulation therapies, which have proven their effectiveness for managing anger and learning positive coping skills. The underlying theory is that people can minimize their negative feelings and behaviors when they are aware of their irrational beliefs and work to change their minds, by focusing on them continuously.
At the end of the experiment, the number of aggressive episodes in the last weeks of the intervention will be measured.
The differences between the new scores, with respect to the initial ones, will be used to assess the efficacy of the intervention.
- Conditions
- Passive-Aggressive Personality Disorder
- Being tested
- Use of biofeedback and virtual reality in the treatment of aggressive outbursts
- Keywords
- Aggressive episodes, Emotional dysregulation, Physiological signals, Virtual reality, Biofeedback
- Medical subject headings
- Passive-Aggressive Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of biofeedback and virtual reality in the treatment of aggressive outburstsBehavioural
Participants are trained to identify their physiological response when they are relaxed and when an outburst is coming. They are treated with cognitive, behavioral and emotional self-regulation therapies for managing anger and learning positive coping skills. Biofeedback toghether with virtual reality help them to improve their recognition and control of emotions.
| Study group | Role | What they receive |
|---|---|---|
| Tweens and teens | Experimental | Kids between 10 and 16. ADHD, Asperger or ODD, with lack of aggressiveness control. Receives: Behavioral: Use of biofeedback and virtual reality in the treatment of aggressive outbursts |
| Control group | No intervention | children who will not receive the experimental treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability (HRV)
The HRV is especially interesting because it allows as-sessing the activity of the parasympathetic and sympathetic pathways of the autonomic nervous system. We used a wearable placed in the chest with Ag/AgCl electrodes for ECG, placed following the Einthoven's II lead positions. The position of R wave is determined using an appropriate algorithm and then time difference between two consecutive R waves is calculated, this time difference is used to calculed HR.
We used 30s-length sliding windows with an overlap of 50%. The instantaneous HR is given by the average HR in such a window after removing the outliers.
Measured: 1 hour
electrodermal activity (EDA)
EDA is a measure of conductivity of human skin cause by the sweating, and can provide an indication of changes in human sympathetic nervous system (SNS). To process EDA data, we use Ledalab tools, configured with Continuous Decomposition Analysis (CDA) to recover the characteristics of the underlying signal of the sudomotor nerve; with Standard trough-to-peak (TTP), which analyzes maximums and minimums of the data window; and with Global that offers general values of the data. Recorded data are adapted to Ledalab input format by adding events in the time points when the experimenter introduces a tag. We shall use a two-second window with an overlap of 50% and a sensitivity of 1 μS.
Measured: 1 hour
Electroencephalography (EEG)
The EEG portrays the functioning of the brain. The recording of those signals will be done at a sampling rate of 125 Hz by OpenBCI. In this study it will be used the 16-channel configuration at a sampling rate of 125Hz and the following electrode placement: FP1, FP2, F1, F2, F5, F6, Cz, C3, C4, T7, T8, Pz, P3, P4, O1, O2 (Figure 5). Additional reference and ground electrodes will be placed on the right ear and Fpz positions respectively.
Measured: 1 hour
Breathing Rate (BR)
Number of breaths a person takes per minute.
Measured: 1 hour
Skin Temperature (ST)
The temperature of the skin. A minimum window length of 1 min guarantees a spectral resolution of 0.017 Hz at a sampling frequency of 13 Hz.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Sep 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Passive-Aggressive Personality DisorderStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto para el Estudio de la Biología de la Reproducción Humana
- Responsible party
- Principal investigator, Isabel Gómez González, University of Seville
- Investigators
- Isabel M Gomez-Gonzalez, Phd, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748808
- Sponsor's protocol ID
- BReTIA
- Acronym
- BReTIA
- Status last verified
- Oct 2024
- First submitted
- 19 Jan 2023
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
G. Alsina Masmitja, "Deficits de atencion y trastornos de conducta," Deficits de atencion y trastornos de conducta, pp. 1-259, 2014.
Schonenberg M, Schneidt A, Wiedemann E, Jusyte A. Processing of Dynamic Affective Information in Adults With ADHD. J Atten Disord. 2019 Jan;23(1):32-39. doi: 10.1177/1087054715577992. Epub 2015 Mar 30.
PubMed 25823741Fahlgren MK, Puhalla AA, Sorgi KM, McCloskey MS. Emotion processing in intermittent explosive disorder. Psychiatry Res. 2019 Mar;273:544-550. doi: 10.1016/j.psychres.2019.01.046. Epub 2019 Jan 14.
PubMed 30710810Persico AM, Ricciardello A, Lamberti M, Turriziani L, Cucinotta F, Brogna C, Vitiello B, Arango C. The pediatric psychopharmacology of autism spectrum disorder: A systematic review - Part I: The past and the present. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Aug 30;110:110326. doi: 10.1016/j.pnpbp.2021.110326. Epub 2021 Apr 20.
PubMed 33857522B. M. Appelhans and L. J. Luecken, "Heart rate variability as an index of regulated emotional responding," Review of general psychology, vol. 10, no. 3, pp. 229-240, 2006.
Costescu C, Sogor M, Thill S, Rosan A. Emotional Dysregulation in Preschoolers with Autism Spectrum Disorder-A Sample of Romanian Children. Int J Environ Res Public Health. 2021 Oct 12;18(20):10683. doi: 10.3390/ijerph182010683.
PubMed 34682429Liddell BJ, Kemp AH, Steel Z, Nickerson A, Bryant RA, Tam N, Tay AK, Silove D. Heart rate variability and the relationship between trauma exposure age, and psychopathology in a post-conflict setting. BMC Psychiatry. 2016 May 10;16:133. doi: 10.1186/s12888-016-0850-5.
PubMed 27165346Liao YC, Guo NW, Su BY, Chen SJ, Tsai HF, Lee KY. Frontal Beta Activity in the Meta-Intention of Children With Attention Deficit Hyperactivity Disorder. Clin EEG Neurosci. 2021 Mar;52(2):136-143. doi: 10.1177/1550059420933142. Epub 2020 Jun 22.
PubMed 32567956Shereena EA, Gupta RK, Bennett CN, Sagar KJV, Rajeswaran J. EEG Neurofeedback Training in Children With Attention Deficit/Hyperactivity Disorder: A Cognitive and Behavioral Outcome Study. Clin EEG Neurosci. 2019 Jul;50(4):242-255. doi: 10.1177/1550059418813034. Epub 2018 Nov 20.
PubMed 30453757V. Delvigne, L. Ris, T. Dutoit, H. Wannous, and J.-P. Vandeborre, "Vera: Virtual environments recording attention," in 2020 IEEE 8th International Conference on Serious Games and Applications for Health (SeGAH). IEEE, 2020, pp. 1-7.
S. Adabla, L. Nabors, and K. Hamblin, "A scoping review of virtual real- ity interventions for youth with attention-deficit/hyperactivity disorder," Advances in Neurodevelopmental Disorders, vol. 5, no. 3, pp. 304-315, 2021.
Karami B, Koushki R, Arabgol F, Rahmani M, Vahabie AH. Effectiveness of Virtual/Augmented Reality-Based Therapeutic Interventions on Individuals With Autism Spectrum Disorder: A Comprehensive Meta-Analysis. Front Psychiatry. 2021 Jun 23;12:665326. doi: 10.3389/fpsyt.2021.665326. eCollection 2021.
PubMed 34248702A. Capafons and F. Silva, "Cuestionario de autocontrol infantil y adolescente (rev.)," Madrid: TEA, 2001
J. M. Andreu, "Cuestionario de agresividad premeditada e impulsiva en adolescentes," Madrid: Tea Ediciones, 2010
Scarpina F, Tagini S. The Stroop Color and Word Test. Front Psychol. 2017 Apr 12;8:557. doi: 10.3389/fpsyg.2017.00557. eCollection 2017.
PubMed 28446889
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Biofeedback and Virtual Reality as Facilitators of Emotional Recognition in the Treatment of Aggressive Outbursts
- ClinicalTrials.gov ID
- NCT05748808
- Acronym / sponsor ID
- BReTIA / BReTIA
- Conditions
- Passive-Aggressive Personality Disorder
- Keywords
- Aggressive episodes, Emotional dysregulation, Physiological signals, Virtual reality, Biofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Instituto para el Estudio de la Biología de la Reproducción Humana
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 1 Mar 2023 (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.
The methodology will be applied for the treatment of aggressive episodes. Many people show this kind of behavior associated with several psychological disorders like austistic spectrum disorder (ASD). It will be studied the effect of aggressive outbursts on several physiological signals (heart rate (HR), breathing rate (BR), electroencephalography (EEG), etc). The use of those signals in a biofeedback loop could help patients recognize their internal states and avoid imminent aggression. The study want to verify the efficacy of a cognitive therapy that includes biofeedback and virtual reality (VR) and find out the most significant physiological features that are affected by these episodes.
Detailed description
The first goal is to register the scene together with physiological values before, during and after at least up to four aggressive outbursts at home.
Next an outburst is induced and physiological signals before, during and after the aggressive episode are recorded. After it the participants go to a new relaxation phase for another 10-minute period using the VR.
In following sessions, they are trained to identify their physiological response when they are relaxed and when an outburst is coming. To do that, the VR system receives and shows the physiological information on the virtual scenario.
In following sessions, teenagers are then treated with cognitive, behavioral and emotional self-regulation therapies, which have proven their effectiveness for managing anger and learning positive coping skills. The underlying theory is that people can minimize their negative feelings and behaviors when they are aware of their irrational beliefs and work to change their minds, by focusing on them continuously.
At the end of the experiment, the number of aggressive episodes in the last weeks of the intervention will be measured.
The differences between the new scores, with respect to the initial ones, will be used to assess the efficacy of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tweens and teens | Experimental | Behavioral: Use of biofeedback and virtual reality in the treatment of aggressive outburstsKids between 10 and 16. ADHD, Asperger or ODD, with lack of aggressiveness control. |
| Control group | No intervention | –children who will not receive the experimental treatment. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Previous diagnosis of ADHD, Asperger syndrome or oppositional defiant disorder (ODD) combined with a lack of control of their aggressiveness.
- Positive impulsivity result obtained with any of the fol- lowing tests: score lower than 25 in CACIA [13], lower than 50 in CAPI-A [14], greater than 75 in Stroop [15] or greater than 115 in WCST [16].
- Intermittent outburst episodes (verbal aggression includ- ing both arguments and temper tantrums, and physical aggression towards self or others) with a frequency of once a week in the two months prior to the beginning of the intervention.
Key exclusion criteria (1 listed)
- Participants will be excluded if they report (a) current (past month) psychopharmacotherapy, (b) a history of bipolar or psychotic disorder, or (c) a traumatic head injury with a loss of consciousness in excess of 60 minutes.
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 |
|---|---|---|
| Use of biofeedback and virtual reality in the treatment of aggressive outburstsParticipants are trained to identify their physiological response when they are relaxed and when an outburst is coming. They are treated with cognitive, behavioral and emotional self-regulation therapies for managing anger and learning positive coping skills. Biofeedback toghether with virtual reality help them to improve their recognition and control of emotions. | Behavioural | Tweens and teens |
Primary outcome
Heart Rate Variability (HRV)
Time frame: 1 hour
The HRV is especially interesting because it allows as-sessing the activity of the parasympathetic and sympathetic pathways of the autonomic nervous system. We used a wearable placed in the chest with Ag/AgCl electrodes for ECG, placed following the Einthoven's II lead positions. The position of R wave is determined using an appropriate algorithm and then time difference between two consecutive R waves is calculated, this time difference is used to calculed HR. We used 30s-length sliding windows with an overlap of 50%. The instantaneous HR is given by the average HR in such a window after removing the outliers.
electrodermal activity (EDA)
Time frame: 1 hour
EDA is a measure of conductivity of human skin cause by the sweating, and can provide an indication of changes in human sympathetic nervous system (SNS). To process EDA data, we use Ledalab tools, configured with Continuous Decomposition Analysis (CDA) to recover the characteristics of the underlying signal of the sudomotor nerve; with Standard trough-to-peak (TTP), which analyzes maximums and minimums of the data window; and with Global that offers general values of the data. Recorded data are adapted to Ledalab input format by adding events in the time points when the experimenter introduces a tag. We shall use a two-second window with an overlap of 50% and a sensitivity of 1 μS.
Electroencephalography (EEG)
Time frame: 1 hour
The EEG portrays the functioning of the brain. The recording of those signals will be done at a sampling rate of 125 Hz by OpenBCI. In this study it will be used the 16-channel configuration at a sampling rate of 125Hz and the following electrode placement: FP1, FP2, F1, F2, F5, F6, Cz, C3, C4, T7, T8, Pz, P3, P4, O1, O2 (Figure 5). Additional reference and ground electrodes will be placed on the right ear and Fpz positions respectively.
Breathing Rate (BR)
Time frame: 1 hour
Number of breaths a person takes per minute.
Skin Temperature (ST)
Time frame: 1 hour
The temperature of the skin. A minimum window length of 1 min guarantees a spectral resolution of 0.017 Hz at a sampling frequency of 13 Hz.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- BackgroundG. Alsina Masmitja, "Deficits de atencion y trastornos de conducta," Deficits de atencion y trastornos de conducta, pp. 1-259, 2014.
- Background: PubMed 25823741Schonenberg M, Schneidt A, Wiedemann E, Jusyte A. Processing of Dynamic Affective Information in Adults With ADHD. J Atten Disord. 2019 Jan;23(1):32-39. doi: 10.1177/1087054715577992. Epub 2015 Mar 30.
- Background: PubMed 30710810Fahlgren MK, Puhalla AA, Sorgi KM, McCloskey MS. Emotion processing in intermittent explosive disorder. Psychiatry Res. 2019 Mar;273:544-550. doi: 10.1016/j.psychres.2019.01.046. Epub 2019 Jan 14.
- Background: PubMed 33857522Persico AM, Ricciardello A, Lamberti M, Turriziani L, Cucinotta F, Brogna C, Vitiello B, Arango C. The pediatric psychopharmacology of autism spectrum disorder: A systematic review - Part I: The past and the present. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Aug 30;110:110326. doi: 10.1016/j.pnpbp.2021.110326. Epub 2021 Apr 20.
- BackgroundB. M. Appelhans and L. J. Luecken, "Heart rate variability as an index of regulated emotional responding," Review of general psychology, vol. 10, no. 3, pp. 229-240, 2006.
- Background: PubMed 34682429Costescu C, Sogor M, Thill S, Rosan A. Emotional Dysregulation in Preschoolers with Autism Spectrum Disorder-A Sample of Romanian Children. Int J Environ Res Public Health. 2021 Oct 12;18(20):10683. doi: 10.3390/ijerph182010683.
- Background: PubMed 27165346Liddell BJ, Kemp AH, Steel Z, Nickerson A, Bryant RA, Tam N, Tay AK, Silove D. Heart rate variability and the relationship between trauma exposure age, and psychopathology in a post-conflict setting. BMC Psychiatry. 2016 May 10;16:133. doi: 10.1186/s12888-016-0850-5.
- Background: PubMed 32567956Liao YC, Guo NW, Su BY, Chen SJ, Tsai HF, Lee KY. Frontal Beta Activity in the Meta-Intention of Children With Attention Deficit Hyperactivity Disorder. Clin EEG Neurosci. 2021 Mar;52(2):136-143. doi: 10.1177/1550059420933142. Epub 2020 Jun 22.
- Background: PubMed 30453757Shereena EA, Gupta RK, Bennett CN, Sagar KJV, Rajeswaran J. EEG Neurofeedback Training in Children With Attention Deficit/Hyperactivity Disorder: A Cognitive and Behavioral Outcome Study. Clin EEG Neurosci. 2019 Jul;50(4):242-255. doi: 10.1177/1550059418813034. Epub 2018 Nov 20.
- BackgroundV. Delvigne, L. Ris, T. Dutoit, H. Wannous, and J.-P. Vandeborre, "Vera: Virtual environments recording attention," in 2020 IEEE 8th International Conference on Serious Games and Applications for Health (SeGAH). IEEE, 2020, pp. 1-7.
- BackgroundS. Adabla, L. Nabors, and K. Hamblin, "A scoping review of virtual real- ity interventions for youth with attention-deficit/hyperactivity disorder," Advances in Neurodevelopmental Disorders, vol. 5, no. 3, pp. 304-315, 2021.
- Background: PubMed 34248702Karami B, Koushki R, Arabgol F, Rahmani M, Vahabie AH. Effectiveness of Virtual/Augmented Reality-Based Therapeutic Interventions on Individuals With Autism Spectrum Disorder: A Comprehensive Meta-Analysis. Front Psychiatry. 2021 Jun 23;12:665326. doi: 10.3389/fpsyt.2021.665326. eCollection 2021.
- Individual participant dataSharing planned: No
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.
Isabel M Gomez-Gonzalez, Phd principal investigator
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of biofeedback and virtual reality in the treatment of aggressive outbursts in people with Passive-Aggressive Personality Disorder, run by University of Seville at 1 site in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 10 Oct 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabel M Gomez-Gonzalez, Phd (+34954552787, igomez@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (HRV) (time frame: 1 hour). The study lists 5 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 NCT05748808, which also lists 24 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 10 Oct 2024.