Cognitive ImpairmentTRUE-GRITNCT06043765
Reducing Cognitive Impairment in Glioma with Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
A study testing real repetitive transcranial magnetic stimulation (rTMS) and cognitive strategy training in people with Cognitive Impairment and Glioma, run by Linda Douw at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cognitive Impairment, Glioma
- What is being tested?
- real repetitive transcranial magnetic stimulation (rTMS) and cognitive strategy training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Mar 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
VU University Medical Centers, location VUmc
Amsterdam, 1081 HV
Maxine Gorter, MSc, 00314444444, gripopcognitie@amsterdamumc.nl
About this study
Official title: TRUE-GRIT: Reducing Cognitive Impairment in Glioma with Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
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.
- Conditions
- Cognitive Impairment, Glioma
- Being tested
- real repetitive transcranial magnetic stimulation (rTMS), sham repetitive transcranial magnetic stimulation (rTMS), cognitive strategy training
- Keywords
- repetitive transcranial magnetic stimulation (rTMS), cognitive strategy training (CST), cognitive impairment
- Medical subject headings
- Cognitive Dysfunction, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real repetitive transcranial magnetic stimulation (rTMS)Device
real rTMS -- 3 sessions a week/7 weeks (21 sessions)
sham repetitive transcranial magnetic stimulation (rTMS)Device
sham rTMS - 3 sessions a week/7 weeks (21 sessions)
cognitive strategy trainingBehavioural
7 weekly sessions with a trained neuropsychologist.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive strategy training + real rTMS | Experimental | 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) Receives: Device: real repetitive transcranial magnetic stimulation (rTMS); Behavioral: cognitive strategy training |
| Cognitive strategy training + sham rTMS | Sham comparator | 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). Receives: Device: sham repetitive transcranial magnetic stimulation (rTMS); Behavioral: cognitive strategy training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients completing intervention and study protocol
The feasibility will be assessed by number of patients completing the intervention and obligatory study measurements
Measured: Baseline versus directly post-intervention (max. 11 weeks after baseline)
Secondary outcomes (1)
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)
Measured: Weekly during the intervention (7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start24 Mar 2024
- Primary completionDec 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linda Douw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Linda Douw, Amsterdam UMC, location VUmc
- Investigators
- Linda Douw, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043765
- Sponsor's protocol ID
- NL82233.029.22
- Acronym
- TRUE-GRIT
- Status last verified
- Nov 2024
- First submitted
- 8 Sep 2023
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRUE-GRIT: Reducing Cognitive Impairment in Glioma with Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
- ClinicalTrials.gov ID
- NCT06043765
- Acronym / sponsor ID
- TRUE-GRIT / NL82233.029.22
- Conditions
- Cognitive Impairment, Glioma
- Keywords
- repetitive transcranial magnetic stimulation (rTMS), cognitive strategy training (CST), cognitive impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Linda DouwUniversity, hospital or other
- Study start
- 24 Mar 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive strategy training + real rTMS | Experimental | Device: real repetitive transcranial magnetic stimulation (rTMS), Behavioral: cognitive strategy trainingVerum rTMS to PPC contralateral to the tumor (3000 10Hz pulses at 110% RMT, 30 10-s trains, 30s inter-trial interval, 20 mins total) |
| Cognitive strategy training + sham rTMS | Sham comparator | Device: sham repetitive transcranial magnetic stimulation (rTMS), Behavioral: cognitive strategy trainingSham rTMS to PPC contralateral to the tumor (3000 10Hz pulses at 110% RMT, 30 10-s trains, 30s inter-trial interval, 20 mins total). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real repetitive transcranial magnetic stimulation (rTMS)real rTMS -- 3 sessions a week/7 weeks (21 sessions) | Device | Cognitive strategy training + real rTMS |
| sham repetitive transcranial magnetic stimulation (rTMS)sham rTMS - 3 sessions a week/7 weeks (21 sessions) | Device | Cognitive strategy training + sham rTMS |
| cognitive strategy training7 weekly sessions with a trained neuropsychologist. | Behavioural | Cognitive strategy training + real rTMS, Cognitive strategy training + sham rTMS |
Primary outcome
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
1 secondary outcome
Tolerability and side effects of the combination therapy
Time frame: Weekly during the intervention (7 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Website of the GRIP project, of which TRUE-GRIT is part of (in Dutch)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda Douw, PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real repetitive transcranial magnetic stimulation (rTMS) and cognitive strategy training in people with Cognitive Impairment and Glioma, run by Linda Douw at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxine Gorter, MSc (+31615413273, gripopcognitie@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients completing intervention and study protocol (time frame: Baseline versus directly post-intervention (max. 11 weeks after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.