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TRUE-GRIT: Reducing cognitive impairment in glioma with repetitive transcranial magnetic stimulation and cognitive strategy training

TRUE-GRIT: Reducing cognitive impairment in glioma with repetitive transcranial magnetic stimulation and cognitive strategy training - TRUE-GRIT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53811
Enrollment
16
Registered
2023-06-05
Start date
2024-03-24
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain tumor Glioma

Interventions

Patients will receive 7 weeks of combined rTMS/sham + cognitive strategy training (NRMP). 21 sessions of rTMS (3x times a week) and 7 weekly sessions of cognitive strategy training will be given. Al

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 - Stable disease, i.e. no oncological treatment for

Exclusion criteria

Exclusion criteria: - Current pregnancy or have given birth less than three months ago - Current other treatment for cognitive complaints - Karnofsky performance score

Design outcomes

Primary

MeasureTime frame
Feasibility of a combination therapy and study measurements in glioma patients. Feasibility will be assessed by completed intervention and measurements: how many of the included patients finish the intervention and obligatory measurements at T1.

Secondary

MeasureTime frame
A set of exploratory parameters will be used to investigate the feasibility of measurements aimed at assessing treatment effects in a future RCT. These parameters consist of EMA examining objective and subjective cognitive functioning along the whole study trajectory. Additionally, several measurements will be performed at baseline, directly after and six months after treatment, namely neuropsychological assessments, questionnaires for subjective cognitive functioning, questionnaires concerning quality of life, functioning, fatigue, and psychological wellbeing, neurological examination, advanced neuroimaging and clinical parameters (tumor location, undergone previous treatments, medication use) will be assessed. Additionally, tolerability and side-effects of the rTMS treatment will be assessed.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)