Back to resultsReducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training (TRUE-GRIT)
Primary Purpose
Cognitive Impairment, Glioma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation (rTMS)
cognitive strategy training
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Impairment focused on measuring repetitive transcranial magnetic stimulation (rTMS), cognitive strategy training (CST), cognitive impairment
Eligibility 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
Sites / Locations
- VU University Medical Centers, location VUmc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Cognitive strategy training + real rTMS
Cognitive strategy training + sham rTMS
Arm 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)
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).
Outcomes
Primary Outcome Measures
Number of patients completing intervention and study protocol
The feasibility will be assessed by number of patients completing the intervention and obligatory study measurements
Secondary Outcome Measures
Tolerability and side effects of the combination therapy
Tolerability and side-effects will be assessed with an in-house-made questionnaire (with yes/no and open questions)
Full Information
NCT ID
NCT06043765
First Posted
September 8, 2023
Last Updated
September 15, 2023
Sponsor
Amsterdam UMC, location VUmc
1. Study Identification
Unique Protocol Identification Number
NCT06043765
Brief Title
Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
Acronym
TRUE-GRIT
Official Title
TRUE-GRIT: Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
August 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Glioma
Keywords
repetitive transcranial magnetic stimulation (rTMS), cognitive strategy training (CST), cognitive impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive strategy training + real rTMS
Arm Type
Experimental
Arm 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)
Arm Title
Cognitive strategy training + sham rTMS
Arm Type
Sham Comparator
Arm 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).
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation (rTMS)
Intervention Description
real rTMS versus sham rTMS
Intervention Type
Behavioral
Intervention Name(s)
cognitive strategy training
Intervention Description
7 weekly sessions with a trained neuropsychologist.
Primary Outcome Measure Information:
Title
Number of patients completing intervention and study protocol
Description
The feasibility will be assessed by number of patients completing the intervention and obligatory study measurements
Time Frame
Baseline versus directly post-intervention (max. 11 weeks after baseline)
Secondary Outcome Measure Information:
Title
Tolerability and side effects of the combination therapy
Description
Tolerability and side-effects will be assessed with an in-house-made questionnaire (with yes/no and open questions)
Time Frame
Weekly during the intervention (7 weeks)
Other Pre-specified Outcome Measures:
Title
Exploratory outcomes: neurocognitive functioning, pre- and post-treatment brain activity, connectivity and network topology.
Description
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.
Time Frame
Baseline versus directly post-intervention (max. 11 weeks after baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maxine Gorter, MSc
Phone
+31615413273
Email
gripopcognitie@amsterdamumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Douw, PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
VU University Medical Centers, location VUmc
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.amc.nl/web/research/trials-collaborations/het-grip-programma.htm
Description
Website of the GRIP project, of which TRUE-GRIT is part of (in Dutch)
Learn more about this trial
Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
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