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Survivors of Childhood CancerWINNERSNCT06312969

Technological Gaming in Cancer Survivors (WINNERS)

A study testing Video game based training in people with Survivors of Childhood Cancer, run by Antonio Pérez Martínez at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

HYPOTHESIS 1. Neurocognitive deficits in cancer survivors are underestimated. They represent a very limiting long-term side effect in this group of patients. 2. An individualized, planned and limited intervention using technological gaming can improve neurocognitive function in these pediatric patients by taking… Read more about this study

Who is it for?
Ages 8 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Survivors of Childhood Cancer
What is being tested?
Video game based training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteSpain
Study dates
23 Feb 2023to Feb 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 8 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Patients between 8 and 17 years of age at the time of recruitment.
  • Have completed treatment between 1 and 6 years prior to recruitment.
  • Have had one of the following diagnoses:
  • Patients with CNS disease (posterior fossa tumors and supratentorial gliomas smaller than 1 cm affecting associative areas).
  • Patients with hematologic malignancies (leukemia or lymphoma).
  • Patients with solid tumors.
Show all 14Show fewer
  • Patients with non-malignant hematological diseases and indication for allogeneic hematopoietic progenitor transplantation.
  • Having received at least one of the following treatments:
  • Central nervous system surgery.
  • Central nervous system radiotherapy.
  • Intrathecal/intraventricular chemotherapy.
  • Neurotoxic systemic chemotherapy.
  • Hematopoietic stem cell transplantation.
  • Informed consent signed by parent/guardian.

Who cannot join

  • Active oncologic disease or relapse of active oncologic disease.
  • Prior neurological or psychiatric pathology that may preclude trial or treatment evaluations:
  • Psychological or neurocognitive illness or sequelae that preclude neuropsychological assessment or are expected to significantly artifact MRI results (examples: significant decrease in visual acuity, CNS surgical scar that artifacts imaging results, severe cognitive delay that precludes testing, etc.).
  • Psychological or neurocognitive illnesses or sequelae that prevent or contraindicate the use of video games (epilepsy that prevents the use of screens, significant decrease in visual acuity, etc.).
  • Mild or self-limiting neurological or psychiatric pathology that does not interfere with trial diagnosis and treatment (headache, epilepsy in remission with effective treatment, mild cognitive delay, etc.) will be allowed.
  • Current or recent (less than 1 year) use of other cognitive stimulation or brain training that may interfere with study results.
  • Refusal to abstain from the use of the study treatment games in case of being assigned to group B (control group).
  • Medical treatment that may significantly interfere with neuropsychological, imaging or biomarker assessments.

Trial locations and contacts

1 site in 1 country.

Carlos Gonzalez-Perez, MD contact

0034917277223

carlos.gonzalez2@salud.madrid.org

Spain1 site, 1 recruiting

  • Hospital La Paz

    Madrid, 28046

    Carlos Gonzalez-Perez, MD, 0034917277223, carlos.gonzalez2@salud.madrid.org

    Antonio Perez-Martinez, PhD, MD

    Recruiting

Other trials in Spain

About this study

Official title: Cognitive Training Through Technological Gaming To Ameliorate Cognitive Effects Related To Childhood Cancer Treatment (WINNERS)

HYPOTHESIS

  1. Neurocognitive deficits in cancer survivors are underestimated. They represent a very limiting long-term side effect in this group of patients.
  2. An individualized, planned and limited intervention using technological gaming can improve neurocognitive function in these pediatric patients by taking advantage of the plasticity of the central nervous system (CNS) in the pediatric age.
  3. Changes can be demonstrated not only at the cognitive level, but also at the structural and functional level using neuroimaging techniques after our intervention.
  4. In addition to the aforementioned benefits, this therapeutic tool can improve some clinical-analytical markers used in the follow-up of cancer survivors, such as immunological markers like lymphocyte populations and inflammatory cytokines.
  5. The neurocognitive effects of this therapy are not only produced at the time of the intervention, but remain until months after the intervention.
  6. The positive impact of the treatment is not only observed in the patients, but also in the psychological and emotional state of the family members.
Read more

VARIABLES

  1. Clinically relevant improvement with moderate or large effect size in the following parameters as measured by neuropsychological tests.
  2. Statistically significant changes in neuroimaging tests.
  3. Statistically significant changes in immune and inflammatory biomarkers before and after treatment.

STUDY DESIGN In this clinical trial, randomized versus control group, unblinded, the aim is to demonstrate the neuropsychological, structural and functional benefit of an intervention using video games in child cancer survivors.

POPULATION OF THE STUDY The target population participating in the study will include patients of either sex aged 8-17 years who completed cancer treatment 1-5 years ago. They must have received treatment with neurotoxic potential: intrathecal/intraventricular chemotherapy, high-dose chemotherapy with crossing of the blood-brain barrier, CNS radiotherapy or hematopoietic stem cell transplantation (HSCT).

Read the detailed description

BACKGROUND AND RATIONALE Several authors have described specific cognitive damage following cancer treatments (often chemotherapy and radiotherapy), which has been termed "chemo-brain". This condition produces alterations in different neurocognitive fields such as memory, learning, concentration, reasoning, executive functions, attention and visuospatial skills.

In this research project the investigator team propose an intervention aimed at one of the most limiting adverse effects of cancer and its treatment such as neurocognitive deficits through technological game platforms and brain training used in a directed, controlled and supervised manner.

HYPOTHESIS

  1. Neurocognitive deficits in cancer survivors are underestimated. They represent a very limiting long-term side effect in this group of patients.
  2. An individualized, planned and limited intervention using technological gaming can improve neurocognitive function in these pediatric patients by taking advantage of the plasticity of the central nervous system (CNS) in the pediatric age.
  3. Changes can be demonstrated not only at the cognitive level, but also at the structural and functional level using neuroimaging techniques after our intervention.
  4. In addition to the aforementioned benefits, this therapeutic tool can improve some clinical-analytical markers used in the follow-up of cancer survivors, such as immunological markers like lymphocyte populations and inflammatory cytokines.
  5. The neurocognitive effects of this therapy are not only produced at the time of the intervention, but remain until months after the intervention.
  6. The positive impact of the treatment is not only observed in the patients, but also in the psychological and emotional state of the family members.

VARIABLES

  1. Clinically relevant improvement with moderate or large effect size in the following parameters as measured by neuropsychological tests: TAVECI/TAVEC, CATA, TONI-4 (form A), Digits, SDMT, ROCF, TFV, Stroop, Vocabulary
  2. Statistically significant changes in neuroimaging tests. The following variables will be measured:
  3. Structural imaging: volume measurement and Voxel Based Morphometry
  4. Diffusion Imaging: diffusion maps and structural connectivity
  5. Functional imaging: resting state and task based fMRI
  6. Statistically significant changes in immune and inflammatory biomarkers before and after treatment:
  7. Study of lymphocyte populations by parametric flow cytometry: T lymphocytes, B lymphocytes, natural killer (NK) lymphocytes, NK T lymphocytes
  8. Study of inflammatory cytokines by LUMINEX: IL-2, IL-4, IL-6, TNF alpha, IFN gamma, IL-10, IL-17TH, IL-1R antagonist

STUDY DESIGN

In this clinical trial, randomized versus control group, unblinded, the aim is to demonstrate the neuropsychological, structural and functional benefit of an intervention using video games in child cancer survivors, patients will follow the following phases:

  • Informed consent
  • Recruitment, inclusion and exclusion criteria.
  • Initial T0 assessment
  • Randomization
  • Treatment phase for the intervention group. Waiting phase for control group
  • Early post-treatment evaluation T+3
  • Late post-treatment evaluation T+6

POPULATION OF THE STUDY The target population participating in the study will include patients of either sex aged 8-17 years who completed cancer treatment 1-5 years ago. They must have received treatment with neurotoxic potential: intrathecal/intraventricular chemotherapy, high-dose chemotherapy with crossing of the blood-brain barrier, CNS radiotherapy or hematopoietic stem cell transplantation (HSCT).

TREATMENT OF THE STUDY Type of intervention

Cognitive training through 3 types of video games:

  • "Serious games" or "brain-training games".
  • Exer-gaming
  • Skill-training games Method of administration

The patient will receive the treatment for a period of 12 weeks, in which they will commit to use the video games of the intervention with the following pattern:

  • "Brain-training game": sessions of 7-12 minutes with a frequency of 4 days a week.
  • "Exer-gaming": sessions of 15-20 minutes 2 days a week.
  • "Skill-training games": sessions of 15-20 minutes 2 days a week.

SAMPLE SIZE It is planned to recruit 56 patients (28 patients for each group, of which 14 will be from the 8-12 years age group and 14 will be from the 13-17 years age group). Recruitment will be for 12 months, with a follow-up period for each patient of 6 months.

Being tested
Video game based training
Keywords
Cancer Survivors, Survivors of Childhood Cancer, Chemotherapy-related Cognitive Impairment, Functional Magnetic Resonance Imaging (fMRI), Video Games, Exergaming
Medical subject headings
Chemotherapy-Related Cognitive Impairment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video game based trainingBehavioural

    Type of intervention: Cognitive training through 3 types of video games:

    • "Serious games" or "brain-training games".
    • Exer-gaming
    • Skill-training games

    Method of administration: The patient will receive the treatment for a period of 12 weeks, in which they will commit to use the video games of the intervention with the following pattern:

    • "Brain-training game": sessions of 7-12 minutes with a frequency of 4 days a week.
    • "Exer-gaming": sessions of 15-20 minutes 2 days a week.
    • "Skill-training games": sessions of 15-20 minutes 2 days a week.
Study groups in NCT06312969
Study groupRoleWhat they receive
Intervention group with video game-based trainingExperimentalCognitive training through 3 types of video games: * "Serious games" or "brain-training games". * Exer-gaming * Skill-training games Method of administration The patient will receive the treatment for a period of 12 weeks, in which they will commit to use the video games of the intervention with the following pattern: * "Brain-training game": sessions of 7-12 minutes with a frequency of 4 days a week. * "Exer-gaming": sessions of 15-20 minutes 2 days a week. * "Skill-training games": sessions of 15-20 minutes 2 days a week.
Receives: Behavioral: Video game based training
Waiting group (no training)No interventionPatients in waiting group will not receive treatment whilst the 3 month period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SDMT Test

    To evaluate the benefits of treatment at the neurocognitive level by means of neuropsychological tests.

    Measured: Baseline

  2. Change in SDMT Test

    To evaluate the benefits of treatment at the neurocognitive level by means of neuropsychological tests.

    Measured: At 3 months after recruitment

  3. Change in SDMT Test

    To evaluate the benefits of treatment at the neurocognitive level by means of neuropsychological tests.

    Measured: At 6 months after recruitment

  4. "DIGITOS" Test

    To evaluate the benefits of treatment at the neurocognitive level (processing speed)

    Measured: Baseline

  5. Change in "DIGITOS" Test

    To evaluate the benefits of treatment at the neurocognitive level (processing speed)

    Measured: At 3 months after recruitment

  6. Change in "DIGITOS" Test

    To evaluate the benefits of treatment at the neurocognitive level (processing speed)

    Measured: At 6 months after recruitment

  7. "TONI-4" test

    To evaluate the benefits of treatment at the neurocognitive level (non-verbal intelligence)

    Measured: Baseline

  8. Change in "TONI-4" test

    To evaluate the benefits of treatment at the neurocognitive level (non-verbal intelligence)

    Measured: At 3 months after recruitment

  9. Change in "TONI-4" test

    To evaluate the benefits of treatment at the neurocognitive level (non-verbal intelligence)

    Measured: At 6 months after recruitment

  10. "ROCF" test

    To evaluate the benefits of treatment at the neurocognitive level (visuo-constructional ability and non-verbal memory)

    Measured: Baseline

  11. Change in "ROCF" test

    To evaluate the benefits of treatment at the neurocognitive level (visuo-constructional ability and non-verbal memory)

    Measured: At 3 months after recruitment

  12. Change in "ROCF" test

    To evaluate the benefits of treatment at the neurocognitive level (visuo-constructional ability and non-verbal memory)

    Measured: At 6 months after recruitment

  13. "TFV" test

    To evaluate the benefits of treatment at the neurocognitive level (verbal fluency)

    Measured: Baseline

  14. Change in "TFV" test

    To evaluate the benefits of treatment at the neurocognitive level (verbal fluency)

    Measured: At 3 months after recruitment

  15. Change in "TFV" test

    To evaluate the benefits of treatment at the neurocognitive level (verbal fluency)

    Measured: At 6 months after recruitment

  16. "STROOP" test

    To evaluate the benefits of treatment at the neurocognitive level (selective attention and inhibitory control)

    Measured: Baseline

  17. Change in "STROOP" test

    To evaluate the benefits of treatment at the neurocognitive level (selective attention and inhibitory control)

    Measured: At 3 months after recruitment

  18. Change in "STROOP" test

    To evaluate the benefits of treatment at the neurocognitive level (selective attention and inhibitory control)

    Measured: At 6 months after recruitment

  19. "TAVECI" test

    To evaluate the benefits of treatment at the neurocognitive level (verbal learning)

    Measured: Baseline

  20. Change in "TAVECI" test

    To evaluate the benefits of treatment at the neurocognitive level (verbal learning)

    Measured: At 3 months after recruitment

  21. Change in "TAVECI" test

    To evaluate the benefits of treatment at the neurocognitive level (verbal learning)

    Measured: At 6 months after recruitment

  22. "CPT3"

    To evaluate the benefits of treatment at the neurocognitive level (performance in attention tasks)

    Measured: Baseline

  23. Change in "CPT3"

    To evaluate the benefits of treatment at the neurocognitive level (performance in attention tasks)

    Measured: At 3 months after recruitment

  24. Change in "CPT3"

    To evaluate the benefits of treatment at the neurocognitive level (performance in attention tasks)

    Measured: At 6 months after recruitment

  25. "BRIEF" survey

    To evaluate the benefits of treatment at the neurocognitive level (assessment of executive functions by parents)

    Measured: Baseline

  26. Change in "BRIEF" survey

    To evaluate the benefits of treatment at the neurocognitive level (assessment of executive functions by parents)

    Measured: At 3 months after recruitment

  27. Change in "BRIEF" survey

    To evaluate the benefits of treatment at the neurocognitive level (assessment of executive functions by parents)

    Measured: At 6 months after recruitment

  28. "BASC" survey

    To evaluate the benefits of treatment at the neurocognitive level (Behavior Assesment)

    Measured: Baseline

  29. Change in "BASC" survey

    To evaluate the benefits of treatment at the neurocognitive level (Behavior Assesment)

    Measured: At 3 months after recruitment

  30. Change in "BASC" survey

    To evaluate the benefits of treatment at the neurocognitive level (Behavior Assesment)

    Measured: At 6 months after recruitment

  31. Statistically significant changes in neuroimaging tests

    Changes in structural imaging (white matter volume, gray matter volume and total intracranial volume, brain lobe volume and voxel-based morphometry), in diffusion (diffusion maps and structural connectivity) and in functional imaging (resting-state fMRI and task-based fMRI).

    Measured: At 3 months after recruitment

  32. Statistically significant changes in neuroimaging tests

    Changes in structural imaging (white matter volume, gray matter volume and total intracranial volume, brain lobe volume and voxel-based morphometry), in diffusion (diffusion maps and structural connectivity) and in functional imaging (resting-state fMRI and task-based fMRI).

    Measured: At 6 months after recruitment

  33. Immune and inflammatory biomarkers

    Study of lymphocyte populations by parametric flow cytometry (T lymphocytes, B lymphocytes, NK lymphocytes, NK T lymphocytes) and inflammatory cytokines by LUMINEX (IL-2, IL-4, IL-6, TNF alpha, IFN gamma, IL-10, IL-17a, IL-1R antagonist)

    Measured: Baseline

  34. Statistically significant changes in immune and inflammatory biomarkers

    Study of lymphocyte populations by parametric flow cytometry (T lymphocytes, B lymphocytes, NK lymphocytes, NK T lymphocytes) and inflammatory cytokines by LUMINEX (IL-2, IL-4, IL-6, TNF alpha, IFN gamma, IL-10, IL-17a, IL-1R antagonist)

    Measured: At 3 months after recruitment

  35. Statistically significant changes in immune and inflammatory biomarkers

    Study of lymphocyte populations by parametric flow cytometry (T lymphocytes, B lymphocytes, NK lymphocytes, NK T lymphocytes) and inflammatory cytokines by LUMINEX (IL-2, IL-4, IL-6, TNF alpha, IFN gamma, IL-10, IL-17a, IL-1R antagonist)

    Measured: At 6 months after recruitment

Secondary outcomes (2)

  1. Prevalence

    To define the prevalence of neurocognitive deficit in cancer survivors in our population.

    Measured: Baseline

  2. Perception of the family measured by satisfaction survey

    To analyze the psychological and emotional perception of family members after a controlled intervention using video games.

    Measured: Through study completion, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start23 Feb 2023
  3. Primary completionSep 2024 (estimated)
  4. Study completionFeb 2025 (estimated)

Resources

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
Model description
Randomized versus control group clinical trial.
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06312969
Sponsor's protocol ID
2022.301
Acronym
WINNERS
Status last verified
Mar 2024
First submitted
9 Jun 2023
Last updated
15 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all collected IPD

Publications

  • Alonso Puig M, Alonso-Prieto M, Miro J, Torres-Luna R, Plaza Lopez de Sabando D, Reinoso-Barbero F. The Association Between Pain Relief Using Video Games and an Increase in Vagal Tone in Children With Cancer: Analytic Observational Study With a Quasi-Experimental Pre/Posttest Methodology. J Med Internet Res. 2020 Mar 30;22(3):e16013. doi: 10.2196/16013.

    PubMed 32224482

  • Argyriou AA, Assimakopoulos K, Iconomou G, Giannakopoulou F, Kalofonos HP. Either called "chemobrain" or "chemofog," the long-term chemotherapy-induced cognitive decline in cancer survivors is real. J Pain Symptom Manage. 2011 Jan;41(1):126-39. doi: 10.1016/j.jpainsymman.2010.04.021. Epub 2010 Sep 15.

    PubMed 20832978

  • Semendric I, Pollock D, Haller OJ, George RP, Collins-Praino LE, Whittaker AL. Impact of "chemobrain" in childhood cancer survivors on social, academic, and daily living skills: a qualitative systematic review protocol. JBI Evid Synth. 2022 Jan 1;20(1):222-228. doi: 10.11124/JBIES-21-00115.

    PubMed 34341312

  • Dovis S, Van der Oord S, Wiers RW, Prins PJ. Improving executive functioning in children with ADHD: training multiple executive functions within the context of a computer game. a randomized double-blind placebo controlled trial. PLoS One. 2015 Apr 6;10(4):e0121651. doi: 10.1371/journal.pone.0121651. eCollection 2015.

    PubMed 25844638

  • Gerbie MV. Management of the adolescent girl exposed in utero to DES. Pediatr Ann. 1981 Dec;10(12):23-6.

    PubMed 7335401

  • Conklin HM, Ogg RJ, Ashford JM, Scoggins MA, Zou P, Clark KN, Martin-Elbahesh K, Hardy KK, Merchant TE, Jeha S, Huang L, Zhang H. Computerized Cognitive Training for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors: A Randomized Controlled Trial. J Clin Oncol. 2015 Nov 20;33(33):3894-902. doi: 10.1200/JCO.2015.61.6672. Epub 2015 Oct 12.

    PubMed 26460306

  • Conklin HM, Ashford JM, Clark KN, Martin-Elbahesh K, Hardy KK, Merchant TE, Ogg RJ, Jeha S, Huang L, Zhang H. Long-Term Efficacy of Computerized Cognitive Training Among Survivors of Childhood Cancer: A Single-Blind Randomized Controlled Trial. J Pediatr Psychol. 2017 Mar 1;42(2):220-231. doi: 10.1093/jpepsy/jsw057.

    PubMed 27342301

  • Benzing V, Eggenberger N, Spitzhuttl J, Siegwart V, Pastore-Wapp M, Kiefer C, Slavova N, Grotzer M, Heinks T, Schmidt M, Conzelmann A, Steinlin M, Everts R, Leibundgut K. The Brainfit study: efficacy of cognitive training and exergaming in pediatric cancer survivors - a randomized controlled trial. BMC Cancer. 2018 Jan 3;18(1):18. doi: 10.1186/s12885-017-3933-x.

    PubMed 29298678

  • da Silva Alves R, Abdalla DR, Iunes DH, Mariano KOP, Borges JBC, Murta EFC, Michelin MA, Carvalho LC. Influence of an Exergaming Training Program on Reducing the Expression of IL-10 and TGF-beta in Cancer Patients. Games Health J. 2020 Dec;9(6):446-452. doi: 10.1089/g4h.2020.0022. Epub 2020 Jun 4.

    PubMed 32498637

  • Spitzhuttl JS, Kronbichler M, Kronbichler L, Benzing V, Siegwart V, Pastore-Wapp M, Kiefer C, Slavova N, Grotzer M, Roebers CM, Steinlin M, Leibundgut K, Everts R. Impact of non-CNS childhood cancer on resting-state connectivity and its association with cognition. Brain Behav. 2021 Jan;11(1):e01931. doi: 10.1002/brb3.1931. Epub 2020 Nov 18.

    PubMed 33205895

  • Lee H, Voss MW, Prakash RS, Boot WR, Vo LT, Basak C, Vanpatter M, Gratton G, Fabiani M, Kramer AF. Videogame training strategy-induced change in brain function during a complex visuomotor task. Behav Brain Res. 2012 Jul 1;232(2):348-57. doi: 10.1016/j.bbr.2012.03.043. Epub 2012 Apr 6.

    PubMed 22504276

  • Richlan F, Schubert J, Mayer R, Hutzler F, Kronbichler M. Action video gaming and the brain: fMRI effects without behavioral effects in visual and verbal cognitive tasks. Brain Behav. 2017 Dec 16;8(1):e00877. doi: 10.1002/brb3.877. eCollection 2018 Jan.

    PubMed 29568680

  • Gonzalez-Perez C, Fernandez-Jimenez E, Moran E, Melero H, Malpica N, Alvarez-Linera J, Alonso Puig M, Plaza D, Perez-Martinez A. Study protocol for a randomized controlled clinical trial of a multifaceted cognitive training program using video games in childhood cancer survivors. PLoS One. 2025 Sep 2;20(9):e0314118. doi: 10.1371/journal.pone.0314118. eCollection 2025.

    PubMed 40892751

Questions about this trial

What is this clinical trial studying?

A study testing Video game based training in people with Survivors of Childhood Cancer, run by Antonio Pérez Martínez 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 14 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: status not confirmed, as of the sponsor's last update on 15 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 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 Carlos Gonzalez-Perez, MD (0034917277223, carlos.gonzalez2@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SDMT Test (time frame: Baseline). The study lists 35 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 NCT06312969, which also lists 13 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 15 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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