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

Cognitive Impairment Clinical Trial

— TRUE-GRIT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06043765
• Other study ID #: NL82233.029.22
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: August 2026

Study information

• Verified date: September 2023
• Source: Amsterdam UMC, location VUmc
• Contact: Maxine Gorter, MSc
• Phone: +31615413273
• Email: gripopcognitie[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: August 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Glioma

Intervention

Device:
• repetitive transcranial magnetic stimulation (rTMS)
real rTMS versus sham rTMS

Behavioral:
• cognitive strategy training
7 weekly sessions with a trained neuropsychologist.

Locations

Country	Name	City	State
Netherlands	VU University Medical Centers, location VUmc	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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)

External Links

•   Website of the GRIP project, of which TRUE-GRIT is part of (in Dutch)