Individualized Magnetic Stimulation for Post-stroke Cognitive Recovery: Optimization, Validation & Efficacy

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Mental Disorders Nervous System Diseases Neurocognitive Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Active TMS disruption

Device

Active TMS disruption delivered to the personalized target

Sham TMS disruption

Device

Sham TMS disruption delivered to the personalized target

Primary outcomes

Change in n-back test performance

Time frame: during TMS disruption

Study contacts

Contact information is provided by the study sponsor or research team.

Jord Vink, PhD

CONTACT

[email protected]

+31302535521

Sponsors and collaborators

Lead sponsor

Jord Vink

Other

Registry information

Acronym: IMPROVE

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Sep 2, 2025
Registry last updated: Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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