The effect of modafinil on fatigue, cognition and functional connectivity in low-grade glioma patients: a double-blind randomized trial.
Phase 3
Recruiting
- Conditions
- brain tumorfatigue10029211
- Registration Number
- NL-OMON31528
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 64
Inclusion Criteria
(1) Reported severe fatigue (score > 35) on the Checklist Individual Strength (CIS), (2) histologically proven LGG without signs of tumor recurrence in the last year, and (3) written informed consent.
Exclusion Criteria
(1) anti-tumor treatment other than antiepileptic drugs (e.g. chemotherapy, radiotherapy, corticosteroids), (2) psychiatric disease or symptoms, (3) insufficient mastery of the English or Dutch language, (4) inability to communicate adequately.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The CIS will be used as main study parameter, as a measure of fatigue. Quality<br /><br>of Life will be assessed by means of the SF-36, BCM20, and MOS. The CES-D will<br /><br>be administered to investigate levels of depression. A neuropsychological test<br /><br>battery assessing a range of cognitive functions will be administered. MEG<br /><br>recordings will take place during resting state, which means no-task and<br /><br>eyes-closed; analyses will be done with synchronization likelihood. Assessment<br /><br>of all parameters will take place at baseline (pretreatment; t0), t1<br /><br>(immediately after six weeks of first treatment with placebo or modafinil) and<br /><br>t2 (immediately after six weeks of second treatment with placebo or modafinil).</p><br>
- Secondary Outcome Measures
Name Time Method <p>n.a.</p><br>