Brain stimulation to improve arm recovery after a stroke
Brain STimulation for Arm Recovery After Stroke 2
This study will test whether short bursts of transcranial magnetic stimulation (continuous theta burst, cTBS) added to usual rehabilitation help adults who recently had a first unilateral stroke regain arm function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 454 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 16 sites ('s-Hertogenbosch and 15 other locations) |
| Trial ID | NCT06265766 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with a first-ever unilateral ischemic stroke or intracerebral hemorrhage, unilateral upper limb paresis (motricity index 9–99), able to start cTBS within 21 days of stroke, and able to give informed consent are ideal candidates.
Not a fit: People with prior upper limb paresis, contraindications to TMS (including certain implanted metal devices), a history of epilepsy, severe impairments that prevent participation, or life expectancy under one year are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding cTBS to early rehabilitation could meaningfully improve arm function and shorten time spent in rehabilitation for people after stroke.
How similar studies have performed: A preceding phase II trial (B‑STARS) reported a 17% absolute additional improvement in ARAT at three months and reduced rehabilitation length of stay, indicating promising prior results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
's-Hertogenbosch and 15 other locations
- Tolbrug — 's-Hertogenbosch, Netherlands (Not_yet_recruiting)
- Reade — Amsterdam, Netherlands (Recruiting)
- Revalidatie Friesland — Beetsterzwaag, Netherlands (Recruiting)
- Revant — Breda, Netherlands (Recruiting)
- MRC Aardenburg — Doorn, Netherlands (Not_yet_recruiting)
- Libra Blixembosch — Eindhoven, Netherlands (Recruiting)
- University Medical Center Groningen — Groesbeek, Netherlands (Not_yet_recruiting)
- Merem — Hilversum, Netherlands (Recruiting)
- Adelante — Hoensbroek, Netherlands (Recruiting)
- Basalt — Leiden, Netherlands (Recruiting)
- Sint Maartenskliniek — Nijmegen, Netherlands (Recruiting)
- Basalt — The Hague, Netherlands (Recruiting)
- Libra Leijpark — Tilburg, Netherlands (Recruiting)
- De Hoogstraat — Utrecht, Netherlands (Recruiting)
- Heliomare — Wijk aan Zee, Netherlands (Recruiting)
- Vogellanden — Zwolle, Netherlands (Recruiting)
Study contacts
- Study coordinator: Jord Vink, PhD
- Email: j.j.vink-5@umcutrecht.nl
- Phone: +31634959811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.