NCT06468176 Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients With Grade 2 or 3 Diffuse Glioma
| NCT ID | NCT06468176 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle |
| Condition | Glioma, Malignant |
| Study Type | INTERVENTIONAL |
| Enrollment | 187 participants |
| Start Date | 2024-07-05 |
| Primary Completion | 2027-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 187 participants in total. It began in 2024-07-05 with a primary completion date of 2027-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Diffuse low-grade glioma are rare brain tumors affecting young subjects (median age at diagnosis 38 years for grade 2 and 49 years for grade 3). Cognitive symptoms are common in these patients, including memory, attention and executive function disorders. These disorders may have a deleterious impact on patients' professional, family and social lives, and have a negative impact on their quality of life. The benefits of cognitive rehabilitation have been demonstrated in other neurological pathologies. Furthermore, due to limited access to rehabilitation by neuropsychologists, some studies have evaluated the impact of digital cognitive rehabilitation programs. However, it cannot replace human support.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years old, no age limit; * Histo-molecular diagnosis of grade 2 or 3 diffuse glioma according to World Health Organization (WHO) Classification 2016, regardless of oncological treatments previously received; * Patient in satisfactory general condition for the study, defined by a WHO performance index ≤ 2 (ECOG-Performance Status (PS) ≤ 2); * Neurosurgical excision (excluding biopsy) performed ≥ 12 months previously; * In the case of oncological treatment, patient who has completed his sessions (radiotherapy, chemotherapy) for ≥ 6 months; * Patient presenting a cognitive complaint defined as a response rated at least "Fairly" to at least one of the 2 items (n°20 and 25) assessing cognitive complaint in the EORTC QLQ-C30 questionnaire (i.e., defined as a score on the "Cognitive Functioning" scale ≤ 66.67); * Fluent in French; * Affiliation to the French Social Security System; * Possible regular use of a digital tool with Internet access; * Signature of informed consent prior to any study procedure. Exclusion Criteria: * Visual or auditory deficit not corrected to normal and/or preventing use of computer tools (i.e., homonymous lateral hemianopia is not a criterion for non-inclusion) ; * Concurrent participation in a study with cognition as primary endpoint (e.g., "POLCA", " POLO " clinical trials) ; * Legal incapacity or physical, psychological, social or geographical conditions preventing the patient from signing the consent form or completing the study ; * Unstable or uncontrolled psychiatric syndrome (i.e., psychotropic treatments are not a criterion for non-inclusion if doses are stable) ; * Known severe cognitive impairment (e.g., neurodegenerative disease, sequelae of head trauma, etc.) or defined by a score ≤ 20 on the MoCA test or impacting the ability to use digital tools at home ; * Oncological treatment (radiotherapy and/or chemotherapy and/or surgery) planned within 4 months of inclusion. Targeted anti-Isocitrate DeHydrogenase (IDH) therapies are authorized.
Contact & Investigator
Amelie DARLIX, MD
STUDY CHAIR
Institut de Cancérologie de Montpellier (ICM)
Frequently Asked Questions
Who can join the NCT06468176 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioma, Malignant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06468176 currently recruiting?
Yes, NCT06468176 is actively recruiting participants. Contact the research team at Aurore.Moussion@icm.unicancer.fr for enrollment information.
Where is the NCT06468176 trial being conducted?
This trial is being conducted at Montpellier, France, Amiens, France, Bordeaux, France, Lyon, France and 4 additional locations.
Who is sponsoring the NCT06468176 clinical trial?
NCT06468176 is sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. The principal investigator is Amelie DARLIX, MD at Institut de Cancérologie de Montpellier (ICM). The trial plans to enroll 187 participants.