TRUE-GRIT: Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training

• Sponsor: Amsterdam UMC, location VUmc (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06043765
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Impairment; Glioma	Device: repetitive transcranial magnetic stimulation (rTMS); Behavioral: cognitive strategy training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: TRUE-GRIT: Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Aug 1, 2026

Arms and Interventions

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)	Device: repetitive transcranial magnetic stimulation (rTMS); real rTMS versus sham rTMS; Behavioral: cognitive strategy training; 7 weekly sessions with a trained neuropsychologist.
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).	Device: repetitive transcranial magnetic stimulation (rTMS); real rTMS versus sham rTMS; Behavioral: cognitive strategy training; 7 weekly sessions with a trained neuropsychologist.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

Other Outcome Measures

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)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VU University Medical Centers, location VUmc	Amsterdam		Netherlands	1081 HV

Sponsors and Collaborators

• Amsterdam UMC, location VUmc

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Linda Douw, Associate Professor, Amsterdam UMC, location VUmc
• ClinicalTrials.gov Identifier: NCT06043765
• Other Study ID Numbers: NL82233.029.22
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Linda Douw, Associate Professor, Amsterdam UMC, location VUmc: repetitive transcranial magnetic stimulation (rTMS); cognitive strategy training (CST); cognitive impairment
• Additional relevant MeSH terms: Glioma; Cognitive Dysfunction

Study Results

No Results Posted as of Sep 21, 2023