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

Linda Douw

Status: Enrolling

Conditions: Glioma; Cognitive Impairment

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06043765

NL82233.029.22

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Cognitive strategy training + real rTMS

Experimental group

Description:

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)

Treatment:

Device: real repetitive transcranial magnetic stimulation (rTMS)

Behavioral: cognitive strategy training

Cognitive strategy training + sham rTMS

Sham Comparator group

Description:

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).

Treatment:

Behavioral: cognitive strategy training

Device: sham repetitive transcranial magnetic stimulation (rTMS)