Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training

Study Overview
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Brief Summary
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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.

Official Title
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TRUE-GRIT: Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training

Conditions
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Cognitive Impairment, Glioma

Intervention / Treatment
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* Device: repetitive transcranial magnetic stimulation (rTMS)
* Behavioral: cognitive strategy training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive strategy training + real rTMS<br>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) | Device: repetitive transcranial magnetic stimulation (rTMS)<br>* real rTMS versus sham rTMS<br>Behavioral: cognitive strategy training<br>* 7 weekly sessions with a trained neuropsychologist.<br>|
| Sham Comparator: Cognitive strategy training + sham rTMS<br>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). | Device: repetitive transcranial magnetic stimulation (rTMS)<br>* real rTMS versus sham rTMS<br>Behavioral: cognitive strategy training<br>* 7 weekly sessions with a trained neuropsychologist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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repetitive transcranial magnetic stimulation (rTMS), cognitive strategy training (CST), cognitive impairment