NCT06265766

Brain STimulation for Arm Recovery After Stroke 2

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 454 (estimated)
• Sponsor: Jord Vink · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Active cTBS	10 sessions of active cTBS delivered to the contralesional primary motor cortex, started within 3 weeks after stroke.
DEVICE	Sham cTBS	10 sessions of sham cTBS delivered to the contralesional primary motor cortex, started within 3 weeks after stroke.

Timeline

• Start date: 2024-12-09
• Primary completion: 2029-03-31
• Completion: 2029-12-31
• First posted: 2024-02-20
• Last updated: 2025-08-27

Locations

16 sites across 1 country: Netherlands