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NCT Number: NCT06265766

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tolbrug, 's-Hertogenbosch, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active cTBS

Device

10 sessions of active cTBS delivered to the contralesional primary motor cortex, started within 3 weeks after stroke.

Sham cTBS

Device

10 sessions of sham cTBS delivered to the contralesional primary motor cortex, started within 3 weeks after stroke.

Primary outcomes

  1. Upper extremity section of the Fugl-Meyer Assessment

    Time frame: at 90 days post-stroke

    The score ranges from 0 to 66 points with a higher score indicating better outcome

Secondary outcomes

  1. Upper extremity section of the Fugl-Meyer Assessment

    Time frame: at 12 months post-stroke

    The score ranges from 0 to 66 points with a higher score indicating better outcome

  2. Action Research Arm Test

    Time frame: at 90 days and 12 months post-stroke

    The score ranges from 0 to 57 points with a higher score indicating better outcome

  3. modified Rankin Scale

    Time frame: at 90 days and 12 months post-stroke

    The score ranges from 0 to 6 points with a lower score indicating better outcome

  4. Hand section of Stroke Impact Scale

    Time frame: at 90 days and 12 months post-stroke

    The score ranges from 0 to 25 points with a higher score indicating better outcome

  5. Participation section of Stroke Impact Scale

    Time frame: at 90 days and 12 months post-stroke

    The score ranges from 0 to 40 points with a higher score indicating better outcome

  6. EuroQol-5D

    Time frame: at 90 days and 12 months post-stroke

    The score ranges from 0 to 5 points per item with a higher score indicating better outcome

  7. Nine Hole Peg Test

    Time frame: at 90 days and 12 months post-stroke

    The outcome ranges from 0 to 50 seconds with a shorter outcome indicating better outcome

  8. Ipsilesional corticospinal excitability

    Time frame: within 12 hours after the 10th cTBS session

    Ipsilesional corticospinal excitability is defined as the resting motor threshold of the ipsilesional hemisphere as determined with single pulse TMS. The outcome ranges from 0 to 100% of the machine output

  9. iMTA medical consumption questionnaire

    Time frame: at 6 and 12 months post-stroke

    This questionnaire aims to identify costs associated with medical consumption

  10. iMTA productivity cost questionnaire

    Time frame: At 6 and 12 months post-stroke

    This questionnaire aims to identify costs associated with productivity loss of paid work.

Study contacts

Contact information is provided by the study sponsor or research team.

Jord Vink, PhD

CONTACT

[email protected]

+31634959811

Sponsors and collaborators

Lead sponsor

Jord Vink

Other

Registry information

Acronym: B-STARS2

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Feb 20, 2024
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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