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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06043765
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Linda Douw
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Linda Douw, PhD
Principal Investigator Affiliation	Amsterdam UMC, location VUmc
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cognitive Impairment, Glioma
Study Website:	View Trial Website

Arms & Interventions

Arms

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)

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).

Interventions

Device: - real repetitive transcranial magnetic stimulation (rTMS)

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

Device: - sham repetitive transcranial magnetic stimulation (rTMS)

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

Behavioral: - cognitive strategy training

7 weekly sessions with a trained neuropsychologist.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.