Brain STimulation for Arm Recovery After Stroke 2

Обзор

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

Вмешательства

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

Первичные конечные точки

• Upper extremity section of the Fugl-Meyer Assessment [Срок оценки: at 90 days post-stroke]

Вторичные конечные точки (10)

• Upper extremity section of the Fugl-Meyer Assessment [Срок оценки: at 12 months post-stroke]
• Action Research Arm Test [Срок оценки: at 90 days and 12 months post-stroke]
• modified Rankin Scale [Срок оценки: at 90 days and 12 months post-stroke]
• Hand section of Stroke Impact Scale [Срок оценки: at 90 days and 12 months post-stroke]
• Participation section of Stroke Impact Scale [Срок оценки: at 90 days and 12 months post-stroke]
• EuroQol-5D [Срок оценки: at 90 days and 12 months post-stroke]
• Nine Hole Peg Test [Срок оценки: at 90 days and 12 months post-stroke]
• Ipsilesional corticospinal excitability [Срок оценки: within 12 hours after the 10th cTBS session]
• iMTA medical consumption questionnaire [Срок оценки: at 6 and 12 months post-stroke]
• iMTA productivity cost questionnaire [Срок оценки: At 6 and 12 months post-stroke]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 16 центров

• Tolbrug — 's-Hertogenbosch
• Reade — Amsterdam
• Revalidatie Friesland — Beetsterzwaag
• Revant — Breda
• MRC Aardenburg — Doorn
• Libra Blixembosch — Eindhoven
• University Medical Center Groningen — Groesbeek
• Merem — Hilversum
• … и ещё 8 центров

Идентификаторы

NCT: NCT06265766 · NL85511.041.24 · 85511

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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