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NCT Number: NCT06043765

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

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.

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Glioma Mental Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neurocognitive Disorders Neuroectodermal Tumors

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VU University Medical Centers, location VUmc

Amsterdam, 1081 HV, Netherlands

Location status: Recruiting

Location contact

Maxine Gorter, MSc

CONTACT

[email protected]

00314444444

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

real repetitive transcranial magnetic stimulation (rTMS)

Device

real rTMS -- 3 sessions a week/7 weeks (21 sessions)

SHAM repetitive transcranial magnetic stimulation (rTMS)

Device

sham rTMS - 3 sessions a week/7 weeks (21 sessions)

cognitive strategy training

Behavioral

7 weekly sessions with a trained neuropsychologist.

Primary outcomes

  1. Number of patients completing intervention and study protocol

    Time frame: Baseline versus directly post-intervention (max. 11 weeks after baseline)

    The feasibility will be assessed by number of patients completing the intervention and obligatory study measurements

Secondary outcomes

  1. Tolerability and side effects of the combination therapy

    Time frame: Weekly during the intervention (7 weeks)

    Tolerability and side-effects will be assessed with an in-house-made questionnaire (with yes/no and open questions)

Other outcomes

  1. Exploratory outcomes: neurocognitive functioning, pre- and post-treatment brain activity, connectivity and network topology.

    Time frame: Baseline versus directly post-intervention (max. 11 weeks after baseline)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maxine Gorter, MSc

CONTACT

[email protected]

+31615413273

Sponsors and collaborators

Lead sponsor

Linda Douw

Other

Registry information

Official study title

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

Acronym: TRUE-GRIT

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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