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

November 13, 2024 updated by: Linda Douw

TRUE-GRIT: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Behavioral: cognitive strategy training
7 weekly sessions with a trained neuropsychologist.
Device: real repetitive transcranial magnetic stimulation (rTMS)
real rTMS -- 3 sessions a week/7 weeks (21 sessions)
Sham Comparator: 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).
Behavioral: cognitive strategy training
7 weekly sessions with a trained neuropsychologist.
Device: sham repetitive transcranial magnetic stimulation (rTMS)
sham rTMS - 3 sessions a week/7 weeks (21 sessions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline versus directly post-intervention (max. 11 weeks after baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Weekly during the intervention (7 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline versus directly post-intervention (max. 11 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linda Douw

Investigators

  • Principal Investigator: Linda Douw, PhD, Amsterdam UMC, location VUmc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 15, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL82233.029.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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