Reducing Cognitive Impairment in Glioma with Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
NCT ID: NCT06043765
Last Updated: 2024-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
16 participants
INTERVENTIONAL
2024-03-24
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cognitive strategy training + real rTMS
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)
real repetitive transcranial magnetic stimulation (rTMS)
real rTMS -- 3 sessions a week/7 weeks (21 sessions)
cognitive strategy training
7 weekly sessions with a trained neuropsychologist.
Cognitive strategy training + sham rTMS
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).
sham repetitive transcranial magnetic stimulation (rTMS)
sham rTMS - 3 sessions a week/7 weeks (21 sessions)
cognitive strategy training
7 weekly sessions with a trained neuropsychologist.
Interventions
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real repetitive transcranial magnetic stimulation (rTMS)
real rTMS -- 3 sessions a week/7 weeks (21 sessions)
sham repetitive transcranial magnetic stimulation (rTMS)
sham rTMS - 3 sessions a week/7 weeks (21 sessions)
cognitive strategy training
7 weekly sessions with a trained neuropsychologist.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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Linda Douw
OTHER
Responsible Party
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Linda Douw
Associate Professor
Principal Investigators
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Linda Douw, PhD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC, location VUmc
Locations
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VU University Medical Centers, location VUmc
Amsterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Website of the GRIP project, of which TRUE-GRIT is part of (in Dutch)
Other Identifiers
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NL82233.029.22
Identifier Type: -
Identifier Source: org_study_id
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