StrokeIMPROVENCT07150169
Individualized Magnetic Stimulation for Post-stroke Cognitive Recovery: Optimization, Validation & Efficacy
A study testing Active TMS disruption in people with Stroke, run by Jord Vink.
Trial summary
Rationale: 75% of all stroke survivors suffer from cognitive deficits in the acute phase, with serious implications for their long-term quality of life and societal participation. A promising novel therapy is repetitive transcranial magnetic stimulation (rTMS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Active TMS disruption
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 1 Nov 2027
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- First-ever ischemic stroke or intracerebral haemorrhage in a cerebral hemisphere or the brainstem;
- Cognitive impairment based on assessment by the treating rehabilitation physician.
- Able to perform n-back task at inclusion.
- Inclusion possible within 10 weeks after stroke onset;
- Signed informed consent.
Who cannot join
- Known cognitive impairment prior to stroke onset;
- Absolute contra-indication to TMS: Magnetic sensitive objects implanted in the head or neck area (e.g. cochlear implants, implanted neurostimulator, pacemaker or defibrillator, metal splinters, metal fragments or metal clips), history of epilepsy, pregnancy or other contra-indications that may potentially be harmful as determined by the treating rehabilitation physician;
- Incompetence or severe impairments that can impede study participation as determined by the treating rehabilitation physician (i.e. extreme fatigue, severe communication deficits);
- Life expectancy shorter than one year.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Rationale: 75% of all stroke survivors suffer from cognitive deficits in the acute phase, with serious implications for their long-term quality of life and societal participation. A promising novel therapy is repetitive transcranial magnetic stimulation (rTMS). Only a handful of studies have attempted to promote cognitive functioning after stroke with rTMS. These studies exclusively used a one-size-fits-all approach, which had limited success, as post-stroke cognitive deficits are highly variable. We propose a two-step personalized treatment strategy to identify targets for therapeutic TMS for cognitive rehabilitation after stroke. Step one consits of identification of personalized TMS targets by measuring fMRI activity during a representative cognitive task. In step two, TMS disruption is used to temporarily disrupt activity in the targeted brain region to investigate causal involvement of a brain area in cognitive task performance.
Objective: To validate a proof-of-concept to identify personalized targets for therapeutic TMS for cognitive rehabilitation after stroke.
Read more
Study design: A prospective mechanistic intervention study.
Study population: 10 healthy individuals and 15 stroke patients with cognitive impairment
Intervention: Active and sham TMS disruption of personalized targets
Main study endpoints: The n-back test
- Conditions
- Stroke
- Being tested
- Active TMS disruption, Sham TMS disruption
- Keywords
- stroke, transcranial magnetic stimulation, cognitive impairment, TMS, TMS disruption, fMRI
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active TMS disruptionDevice
Active TMS disruption delivered to the personalized target
Sham TMS disruptionDevice
Sham TMS disruption delivered to the personalized target
| Study group | Role | What they receive |
|---|---|---|
| Active TMS disruption | Experimental | Active TMS disruption delivered at 110% RMT Receives: Device: Active TMS disruption |
| Sham TMS disruption | Sham comparator | Active TMS disruption delivered at 20% RMT Receives: Device: Sham TMS disruption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in n-back test performance
Measured: during TMS disruption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- We will perform a prospective mechanistic sham-controlled crossover intervention study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jord Vink
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jord Vink, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150169
- Sponsor's protocol ID
- NL-009409
- Acronym
- IMPROVE
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized patient data can be made available on request
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Magnetic Stimulation for Post-stroke Cognitive Recovery: Optimization, Validation & Efficacy
- ClinicalTrials.gov ID
- NCT07150169
- Acronym / sponsor ID
- IMPROVE / NL-009409
- Conditions
- Stroke
- Keywords
- stroke, transcranial magnetic stimulation, cognitive impairment, TMS, TMS disruption, fMRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Jord VinkUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 2 Sep 2025 (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.
Rationale: 75% of all stroke survivors suffer from cognitive deficits in the acute phase, with serious implications for their long-term quality of life and societal participation. A promising novel therapy is repetitive transcranial magnetic stimulation (rTMS). Only a handful of studies have attempted to promote cognitive functioning after stroke with rTMS. These studies exclusively used a one-size-fits-all approach, which had limited success, as post-stroke cognitive deficits are highly variable. We propose a two-step personalized treatment strategy to identify targets for therapeutic TMS for cognitive rehabilitation after stroke. Step one consits of identification of personalized TMS targets by measuring fMRI activity during a representative cognitive task. In step two, TMS disruption is used to temporarily disrupt activity in the targeted brain region to investigate causal involvement of a brain area in cognitive task performance.
Objective: To validate a proof-of-concept to identify personalized targets for therapeutic TMS for cognitive rehabilitation after stroke.
Study design: A prospective mechanistic intervention study.
Study population: 10 healthy individuals and 15 stroke patients with cognitive impairment
Intervention: Active and sham TMS disruption of personalized targets
Main study endpoints: The n-back test
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- We will perform a prospective mechanistic sham-controlled crossover intervention study.
| Arm | Type | Receives |
|---|---|---|
| Active TMS disruption | Experimental | Device: Active TMS disruptionActive TMS disruption delivered at 110% RMT |
| Sham TMS disruption | Sham comparator | Device: Sham TMS disruptionActive TMS disruption delivered at 20% RMT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years;
- First-ever ischemic stroke or intracerebral haemorrhage in a cerebral hemisphere or the brainstem;
- Cognitive impairment based on assessment by the treating rehabilitation physician.
- Able to perform n-back task at inclusion.
- Inclusion possible within 10 weeks after stroke onset;
Key exclusion criteria (4 listed)
- Known cognitive impairment prior to stroke onset;
- Absolute contra-indication to TMS: Magnetic sensitive objects implanted in the head or neck area (e.g. cochlear implants, implanted neurostimulator, pacemaker or defibrillator, metal splinters, metal fragments or metal clips), history of epilepsy, pregnancy or other contra-indications that may potentially be harmful as determined by the treating rehabilitation physician;
- Incompetence or severe impairments that can impede study participation as determined by the treating rehabilitation physician (i.e. extreme fatigue, severe communication deficits);
- Life expectancy shorter than one year.
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 |
|---|---|---|
| Active TMS disruptionActive TMS disruption delivered to the personalized target | Device | Active TMS disruption |
| Sham TMS disruptionSham TMS disruption delivered to the personalized target | Device | Sham TMS disruption |
Primary outcome
Change in n-back test performance
Time frame: during TMS disruption
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 2 Sep 2025.
- Individual participant dataSharing planned: No. Anonymized patient data can be made available on request
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Active TMS disruption in people with Stroke, run by Jord Vink.
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 4 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: opening soon, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Jord Vink, PhD (+31302535521, j.j.vink-5@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in n-back test performance (time frame: during TMS disruption). 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 2 Sep 2025.