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

Not Applicable

Recruiting

• Conditions: Glioma; Cognitive Impairment
• Interventions: Device: repetitive transcranial magnetic stimulation (rTMS); Behavioral: cognitive strategy training

• Registration Number: NCT06043765
• Lead Sponsor: Linda Douw

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-21
• Study Start: 2024-03-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-18
• Primary Completion: 2025-12
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive strategy training + real rTMS	repetitive transcranial magnetic stimulation (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)
Cognitive strategy training + real rTMS	cognitive strategy training	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)
Cognitive strategy training + sham rTMS	repetitive transcranial magnetic stimulation (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).
Cognitive strategy training + sham rTMS	cognitive strategy training	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).

Primary Outcome Measures

Name	Time	Method
Number of patients completing intervention and study protocol	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 Outcome Measures

Name	Time	Method
Tolerability and side effects of the combination therapy	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)

Trial Locations

Locations (1)

VU University Medical Centers, location VUmc; 🇳🇱 Amsterdam, Netherlands