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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive strategy training + real rTMS | Experimental | Verum rTMS to PPC contralateral to the tumor (3000 10Hz pulses at 110% RMT, 30 10-s trains, 30s inter-trial interval, 20 mins total) |
|
| Cognitive strategy training + sham rTMS | Sham Comparator | Sham rTMS to PPC contralateral to the tumor (3000 10Hz pulses at 110% RMT, 30 10-s trains, 30s inter-trial interval, 20 mins total). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| real repetitive transcranial magnetic stimulation (rTMS) | Device | real rTMS -- 3 sessions a week/7 weeks (21 sessions) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients completing intervention and study protocol | The feasibility will be assessed by number of patients completing the intervention and obligatory study measurements | Baseline versus directly post-intervention (max. 11 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability and side effects of the combination therapy | Tolerability and side-effects will be assessed with an in-house-made questionnaire (with yes/no and open questions) | Weekly during the intervention (7 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory outcomes: neurocognitive functioning, pre- and post-treatment brain activity, connectivity and network topology. | 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. | Baseline versus directly post-intervention (max. 11 weeks after baseline) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maxine Gorter, MSc | Contact | +31615413273 | gripopcognitie@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Linda Douw, PhD | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU University Medical Centers, location VUmc | Recruiting | Amsterdam | 1081 HV | Netherlands |
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| Label | URL |
|---|---|
| Website of the GRIP project, of which TRUE-GRIT is part of (in Dutch) | View source |
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| sham repetitive transcranial magnetic stimulation (rTMS) | Device | sham rTMS - 3 sessions a week/7 weeks (21 sessions) |
|
| cognitive strategy training | Behavioral | 7 weekly sessions with a trained neuropsychologist. |
|
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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