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

NCT06043765 | Recruiting

• 1 other identifier: NL82233.029.22
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Impairment; Glioma

Keywords

repetitive transcranial magnetic stimulation (rTMS); cognitive strategy training (CST); cognitive impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tolerability and side effects of the combination therapy

  Weekly during the intervention (7 weeks)

Other Outcomes (1)

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

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

Study Arms (2)

Cognitive strategy training + real rTMS

EXPERIMENTAL

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)

Device: real repetitive transcranial magnetic stimulation (rTMS); Behavioral: cognitive strategy training

Cognitive strategy training + sham rTMS

SHAM COMPARATOR

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).

Device: sham repetitive transcranial magnetic stimulation (rTMS); Behavioral: cognitive strategy training

Interventions

real repetitive transcranial magnetic stimulation (rTMS) DEVICE

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

Cognitive strategy training + real rTMS

sham repetitive transcranial magnetic stimulation (rTMS) DEVICE

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

Cognitive strategy training + sham rTMS

cognitive strategy training BEHAVIORAL

7 weekly sessions with a trained neuropsychologist.

Cognitive strategy training + real rTMS; Cognitive strategy training + sham rTMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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 dosage (for at least 8 weeks) of anti-epileptic medication

You may not qualify if:

• 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

Sponsors & Collaborators

• Linda Douw: lead

Study Sites (1)

VU University Medical Centers, location VUmc

Amsterdam, 1081 HV, Netherlands

RECRUITING

Related Links

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

MeSH Terms

Conditions

Cognitive Dysfunction; Glioma

Condition Hierarchy (Ancestors)

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

Study Officials

• Linda Douw, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxine Gorter, MSc

CONTACT

+31615413273; gripopcognitie@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 21, 2023
• Study Start: March 24, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)