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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06043765
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Linda Douw, Amsterdam UMC, location VUmc

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number of patients completing intervention and study protocol [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043765


Contacts
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Contact: Maxine Gorter, MSc +31615413273 gripopcognitie@amsterdamumc.nl

Locations
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Netherlands
VU University Medical Centers, location VUmc
Amsterdam, Netherlands, 1081 HV
Sponsors and Collaborators
Amsterdam UMC, location VUmc
Investigators
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Principal Investigator: Linda Douw, PhD Amsterdam UMC, location VUmc
Additional Information:
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Responsible Party: Linda Douw, Associate Professor, Amsterdam UMC, location VUmc
ClinicalTrials.gov Identifier: NCT06043765    
Other Study ID Numbers: NL82233.029.22
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Linda Douw, Amsterdam UMC, location VUmc:
repetitive transcranial magnetic stimulation (rTMS)
cognitive strategy training (CST)
cognitive impairment
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Glioma
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders