Combining brain stimulation and cognitive training to improve thinking skills in glioma patients
TRUE-GRIT: Reducing Cognitive Impairment in Glioma with Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
This study is testing if combining brain stimulation with thinking skills training can help adults with glioma improve their cognitive abilities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06043765 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of using a combination of cognitive strategy training (CST) and repetitive transcranial magnetic stimulation (rTMS) to address cognitive impairment in adults diagnosed with glioma. Participants will receive either real or sham rTMS alongside cognitive training aimed at enhancing their cognitive abilities. The study is part of a larger project focused on improving the quality of life for brain tumor patients. The goal is to assess the effectiveness of this dual approach in reducing cognitive deficits associated with glioma.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a histological diagnosis of diffuse glioma and subjective cognitive impairment.
Not a fit: Patients with a Karnofsky performance score below 70 or those currently undergoing other treatments for cognitive complaints may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance cognitive function and quality of life for glioma patients.
How similar studies have performed: While the combination of rTMS and cognitive training is a novel approach, similar studies have shown promise in improving cognitive function in other patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 18 years of age * Histological diagnosis of diffuse glioma (WHO grade 2,3, or 4) * Subjective cognitive impairment, defined as CFQ-score ≥ 44 * Being able to give informed consent and undergo treatment and measurements based on researchers insight * Stable disease, i.e. no oncological treatment for ≤ 2 months prior to inclusion; no radiological progression on the most recent MRI, not older than 6 months, and no clinical progression at inclusion * Stable dosage (for at least 8 weeks) of anti-epileptic medication Exclusion Criteria: * Current pregnancy or have given birth less than three months ago * Current other treatment for cognitive complaints * Karnofsky performance score \<70 * A tumor located in the parietal cortex * TMS exclusion: implanted medical devices (e.g. pacemaker, deep brain stimulator, cochlear implants, medical infusion device, etc.); metal in the body; sleep deprivation * MRI exclusion: extreme claustrophobia or metallic objects in or on the body
Where this trial is running
Amsterdam
- VU University Medical Centers, location VUmc — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Linda Douw, PhD — Amsterdam UMC, location VUmc
- Study coordinator: Maxine Gorter, MSc
- Email: gripopcognitie@amsterdamumc.nl
- Phone: +31615413273
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.