Actively Recruiting
Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients With Grade 2 or 3 Diffuse Glioma
Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2025-12-19
187
Participants Needed
8
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients With Grade 2 or 3 Diffuse Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Institut régional du Cancer de Montpellier
Montpellier, Hérault, France, 34298
Actively Recruiting
2
CHU Amiens
Amiens, France
Not Yet Recruiting
3
CHU Bordeaux
Bordeaux, France
Not Yet Recruiting
4
CHU Lyon
Lyon, France
Not Yet Recruiting
5
Hôpital de la Timone
Marseille, France
Not Yet Recruiting
6
CHU Nancy
Nancy, France
Not Yet Recruiting
7
CHU Nîmes
Nîmes, France
Not Yet Recruiting
8
Institut Claudius Régaud
Toulouse, France, 31059
Not Yet Recruiting
Research Team
A
Aurore MOUSSION
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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