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

Jord Vink

Status: Not yet enrolling

Conditions: Stroke

Treatments: Device: Active TMS disruption; Device: Sham TMS disruption

Study type: Interventional

Funder types: Other

Identifiers

NCT07150169

NL-009409

Details and patient eligibility

About

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

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years;
2. First-ever ischemic stroke or intracerebral haemorrhage in a cerebral hemisphere or the brainstem;
3. Cognitive impairment based on assessment by the treating rehabilitation physician.
4. Able to perform n-back task at inclusion.
5. Inclusion possible within 10 weeks after stroke onset;
6. Signed informed consent.

Exclusion criteria

1. Known cognitive impairment prior to stroke onset;
2. 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;
3. Incompetence or severe impairments that can impede study participation as determined by the treating rehabilitation physician (i.e. extreme fatigue, severe communication deficits);
4. Life expectancy shorter than one year.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Active TMS disruption

Experimental group

Description:

Active TMS disruption delivered at 110% RMT

Treatment:

Device: Active TMS disruption

Sham TMS disruption

Sham Comparator group

Description:

Active TMS disruption delivered at 20% RMT

Treatment:

Device: Sham TMS disruption