Status:
RECRUITING
Reducing Cognitive Impairment in Glioma with Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
Lead Sponsor:
Linda Douw
Conditions:
Cognitive Impairment
Glioma
Eligibility:
All Genders
18-80 years
Phase:
NA
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 magn...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
March 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06043765
Start Date
March 24 2024
End Date
August 1 2026
Last Update
November 18 2024
Active Locations (1)
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1
VU University Medical Centers, location VUmc
Amsterdam, Netherlands, 1081 HV