Brain stimulation to help arm recovery after stroke
Tests repeated brain stimulation with a device in adults recovering from stroke.
Plain-language title generated from the registry record
Registry title: Brain STimulation for Arm Recovery After Stroke 2
Key facts
- Where
- 's-Hertogenbosch, Amsterdam, Beetsterzwaag, Breda, Doorn, Eindhoven, Groesbeek, Hilversum, Hoensbroek, Leiden, Nijmegen, The Hague, Tilburg, Utrecht, Wijk aan Zee, and Zwolle, NetherlandsSee the 16 sites
Where in Netherlands
- Tolbrug's-Hertogenbosch, NetherlandsNot yet recruiting
- ReadeAmsterdam, NetherlandsTaking people
- Revalidatie FrieslandBeetsterzwaag, NetherlandsTaking people
- RevantBreda, NetherlandsTaking people
- MRC AardenburgDoorn, NetherlandsNot yet recruiting
- Libra BlixemboschEindhoven, NetherlandsTaking people
- University Medical Center GroningenGroesbeek, NetherlandsNot yet recruiting
- MeremHilversum, NetherlandsTaking people
- AdelanteHoensbroek, NetherlandsTaking people
- BasaltLeiden, NetherlandsTaking people
- Sint MaartenskliniekNijmegen, NetherlandsTaking people
- BasaltThe Hague, NetherlandsTaking people
- Libra LeijparkTilburg, NetherlandsTaking people
- De HoogstraatUtrecht, NetherlandsTaking people
- HeliomareWijk aan Zee, NetherlandsTaking people
- VogellandenZwolle, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jord Vink
- Trial code
- NCT06265766
- Record updated
- 27 August 2025
- Original description
Rationale: Every year, about 40,000 people in the Netherlands have a stroke. After the initial admission to the hospital, about 15% of stroke survivors is admitted to a rehabilitation center because of remaining disabilities. Three out of four of these patients have upper limb dysfunction, hampering activities of daily living. Upper limb function plays a critical role in the performance of most daily life activities. In our phase II trial B-STARS, continuous theta burst stimulation (cTBS) treatment led to an absolute additional recovery of upper limb function of 17%, as measured with the Action Research Arm Test (ARAT) score three months after stroke. This improvement exceeds the minimal clinically important difference of 10%. cTBS treatment also resulted in a significant improvement in measures of activities and participation (of similar magnitude) and a reduction in the mean length of stay at the rehabilitation center by 18 days.Read full original descriptionShow less
Brain STimulation for Arm Recovery After Stroke 2
Rationale: Every year, about 40,000 people in the Netherlands have a stroke. After the initial admission to the hospital, about 15% of stroke survivors is admitted to a rehabilitation center because of remaining disabilities. Three out of four of these patients have upper limb dysfunction, hampering activities of daily living. Upper limb function plays a critical role in the performance of most daily life activities. In our phase II trial B-STARS, continuous theta burst stimulation (cTBS) treatment led to an absolute additional recovery of upper limb function of 17%, as measured with the Action Research Arm Test (ARAT) score three months after stroke. This improvement exceeds the minimal clinically important difference of 10%. cTBS treatment also resulted in a significant improvement in measures of activities and participation (of similar magnitude) and a reduction in the mean length of stay at the rehabilitation center by 18 days.
Objective: To assess the effectiveness and cost effectiveness of cTBS treatment in promoting upper limb recovery after stroke in patients admitted to a rehabilitation center.
Study design: A phase III, multi-center, double-blind, randomized, sham-controlled, clinical trial.
Study population: 454 patients aged 18 years or older with a first-ever ischemic stroke or intracerebral hemorrhage and a unilateral arm paresis, defined by a Motricity Index between 9 and 99, in whom cTBS treatment can be started within 3 weeks after stroke onset.
Intervention: 10 daily sessions of cTBS delivered over the contralesional primary motor cortex during a period of 2 weeks, delivered immediately before regular care physical therapy of the affected upper limb.
Main study parameters/endpoints: The primary endpoint will be the score on the upper extremity section of the Fugl-Meyer assessment (FM-UE) at 90 days after stroke. Secondary endpoints will include the score on the FM-UE at one year and the scores on the Action Research Arm Test, Nine Hole Peg Test, Stroke Impact Scale, EuroQol 5 Dimensions and modified Rankin Scale at 90 days and one year after stroke
Inclusion: 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: Upper limb paresis prior to stroke onset; 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; Absolute contra-indication to TMS; 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.