Brain STimulation for Arm Recovery After Stroke 2 (B-STARS2)

Jord Vink

Status: Enrolling

Conditions: Stroke

Treatments: Device: Active cTBS; Device: Sham cTBS

Study type: Interventional

Funder types: Other

Identifiers

NCT06265766

NL85511.041.24

85511 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 454 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

454 participants in 2 patient groups

Active cTBS

Experimental group

Description:

Active cTBS delivered with an active TMS coil

Treatment:

Device: Active cTBS

Sham cTBS

Sham Comparator group

Description:

Sham cTBS delivered with a sham TMS coil

Treatment:

Device: Sham cTBS