Reducing Cognitive Impairment in Glioma with Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: real repetitive transcranial magnetic stimulation (rTMS), sham repetitive transcranial magnetic stimulation (rTMS), cognitive strategy training.
- Who it may be relevant to
- Registry conditions: Cognitive Impairment, Glioma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
TRUE-GRIT: Reducing Cognitive Impairment in Glioma with Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
Overview
The TRUE-GRIT study will assess the feasibility of a study protocol investigating the efficacy of a combination therapy consisting of cognitive strategy training (CST) and repetitive transcranial magnetic stimulation (rTMS) to reduce cognitive impairment in adult glioma patients. This study is part of the GRIP-project, a project aimed at investigating interventions for improving quality of life in brain tumor patients.
Interventions
- Device real repetitive transcranial magnetic stimulation (rTMS)
real rTMS -- 3 sessions a week/7 weeks (21 sessions) - Device sham repetitive transcranial magnetic stimulation (rTMS)
sham rTMS - 3 sessions a week/7 weeks (21 sessions) - Behavioral cognitive strategy training
7 weekly sessions with a trained neuropsychologist.
Primary outcome measures
- Number of patients completing intervention and study protocol [Time frame: Baseline versus directly post-intervention (max. 11 weeks after baseline)]
Secondary outcome measures (1)
- Tolerability and side effects of the combination therapy [Time frame: Weekly during the intervention (7 weeks)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- VU University Medical Centers, location VUmc — Amsterdam
Identifiers
NCT: NCT06043765 · NL82233.029.22