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

NCT ID: NCT07150169

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-11-01

Brief 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). 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

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Active TMS disruption

Active TMS disruption delivered at 110% RMT

Group Type: EXPERIMENTAL

Active TMS disruption

Intervention Type: DEVICE

Active TMS disruption delivered to the personalized target

Sham TMS disruption

Active TMS disruption delivered at 20% RMT

Group Type: SHAM_COMPARATOR

Sham TMS disruption

Intervention Type: DEVICE

Sham TMS disruption delivered to the personalized target

Interventions

Active TMS disruption

Active TMS disruption delivered to the personalized target

Intervention Type: DEVICE

Sham TMS disruption

Sham TMS disruption delivered to the personalized target

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jord Vink

OTHER

Sponsor Role: lead

Responsible Party

Jord Vink

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Jord Vink, PhD

Role: CONTACT

j.j.vink-5@umcutrecht.nl

+31302535521

Other Identifiers

NL-009409

Identifier Type: -

Identifier Source: org_study_id