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

NCT07150169 | Not Yet Recruiting

• 1 other identifier: NL-009409
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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

Keywords

stroke; transcranial magnetic stimulation; cognitive impairment; TMS; TMS disruption; fMRI

Outcome Measures

Primary Outcomes (1)

• Change in n-back test performance

  during TMS disruption

Study Arms (2)

Active TMS disruption

EXPERIMENTAL

Active TMS disruption delivered at 110% RMT

Device: Active TMS disruption

Sham TMS disruption

SHAM COMPARATOR

Active TMS disruption delivered at 20% RMT

Device: Sham TMS disruption

Interventions

Active TMS disruption DEVICE

Active TMS disruption delivered to the personalized target

Active TMS disruption

Sham TMS disruption DEVICE

Sham TMS disruption delivered to the personalized target

Sham TMS disruption

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jord Vink: lead

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Jord Vink, PhD

CONTACT

+31302535521; j.j.vink-5@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: We will perform a prospective mechanistic sham-controlled crossover intervention study.

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 2, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share