Cognitive Impairment, Glioma
Conditions
Keywords
repetitive transcranial magnetic stimulation (rTMS), cognitive strategy training (CST), cognitive impairment
Brief summary
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
DEVICEreal repetitive transcranial magnetic stimulation (rTMS)
real rTMS -- 3 sessions a week/7 weeks (21 sessions)
sham rTMS - 3 sessions a week/7 weeks (21 sessions)
BEHAVIORALcognitive strategy training
7 weekly sessions with a trained neuropsychologist.
Sponsors
Linda Douw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients completing intervention and study protocol | Baseline versus directly post-intervention (max. 11 weeks after baseline) | The feasibility will be assessed by number of patients completing the intervention and obligatory study measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability and side effects of the combination therapy | Weekly during the intervention (7 weeks) | Tolerability and side-effects will be assessed with an in-house-made questionnaire (with yes/no and open questions) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory outcomes: neurocognitive functioning, pre- and post-treatment brain activity, connectivity and network topology. | Baseline versus directly post-intervention (max. 11 weeks after baseline) | Exploratory parameters are measured as they will be of relevance for a subsequent RCT in case of proven feasibility. Measurements: MRI, MEG, neuropsychological assessment and questionnaires. |
Countries
Netherlands
Contacts
Primary ContactMaxine Gorter, MSc
Outcome results
None listed