Individualized Magnetic Stimulation for Post-stroke Cognitive Recovery: Optimization, Validation & Efficacy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active TMS disruption, Sham TMS disruption.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Device Active TMS disruption
Active TMS disruption delivered to the personalized target - Device Sham TMS disruption
Sham TMS disruption delivered to the personalized target
Primary outcome measures
- Change in n-back test performance [Time frame: during TMS disruption]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07150169 · NL-009409