Brain stimulation to improve arm recovery after a stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a sham‑controlled interventional study comparing active continuous theta burst stimulation (cTBS) to a sham procedure given early after a first unilateral stroke alongside standard rehabilitation. Eligible adults start treatment within 21 days of stroke and have unilateral upper limb weakness meeting motricity index criteria. Outcomes include measures of upper limb function such as the Action Research Arm Test and measures of activity, participation, and length of stay in rehabilitation. The intervention builds on a phase II trial (B‑STARS) that showed a clinically meaningful 17% absolute improvement in ARAT score and shorter rehabilitation stays.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age, 18 years or older
* First-ever unilateral ischemic stroke or intracerebral hemorrhage in a cerebral hemisphere or the brainstem;
* Unilateral upper limb paresis with a motricity index between 9 and 99;
* Possibility to start cTBS treatment within 21 days after stroke onset;
* Signed informed consent.

Exclusion Criteria:

* Upper limb paresis 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;
* Other contra-indications that may potentially be harmful as determined by the treating rehabilitation physician;
* 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.

Where it's running

• Reade
  Amsterdam, Netherlands Recruiting
• Revalidatie Friesland
  Beetsterzwaag, Netherlands Recruiting
• Revant
  Breda, Netherlands Recruiting
• Libra Blixembosch
  Eindhoven, Netherlands Recruiting
• Merem
  Hilversum, Netherlands Recruiting
• Adelante
  Hoensbroek, Netherlands Recruiting

Study contacts

• Study coordinator: Jord Vink, PhD
• Email: j.j.vink-5@umcutrecht.nl
• Phone: +31634959811

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

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• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

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• Remote Ischaemic Conditioning for Fatigue After Stroke 2

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• Dual-task balance training plus computer-based cognitive training after stroke

  In adults who recently had a stroke, the study tests whether adding computerized cognitive exercises to balance training improves balance and other recovery outcomes.

  Recruiting Matia Foundation · San Sebastián, GUIPUZCOA · NCT07913620

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.