Clinical trial NCT06265766: Brain STimulation for Arm Recovery After Stroke 2
Official title: Brain STimulation for Arm Recovery After Stroke 2
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Transcranial magnetic stimulation
Continuous theta burst stimulation
Upper limb recovery
TMS
cTBS
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 454
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Upper extremity section of the Fugl-Meyer Assessment
timeFrame: at 90 days post-stroke
Secondary outcomes:
measure: Upper extremity section of the Fugl-Meyer Assessment
timeFrame: at 12 months post-stroke
measure: Action Research Arm Test
timeFrame: at 90 days and 12 months post-stroke
measure: modified Rankin Scale
timeFrame: at 90 days and 12 months post-stroke
measure: Hand section of Stroke Impact Scale
timeFrame: at 90 days and 12 months post-stroke
measure: Participation section of Stroke Impact Scale
timeFrame: at 90 days and 12 months post-stroke
measure: EuroQol-5D
timeFrame: at 90 days and 12 months post-stroke
measure: Nine Hole Peg Test
timeFrame: at 90 days and 12 months post-stroke
measure: Ipsilesional corticospinal excitability
timeFrame: within 12 hours after the 10th cTBS session
measure: iMTA medical consumption and productivity cost questionnaire
timeFrame: at 6 and 12 months post-stroke
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Reade
city: Beetsterzwaag
country: Netherlands
facility: Revalidatie Friesland
city: Breda
country: Netherlands
facility: Revant
city: Den Bosch
country: Netherlands
facility: Tolbrug
city: Den Haag
country: Netherlands
facility: Basalt
city: Doorn
country: Netherlands
facility: MRC Aardenburg
city: Eindhoven
country: Netherlands
facility: Libra Blixembosch
city: Groesbeek
country: Netherlands
facility: University Medical Center Groningen
city: Hilversum
country: Netherlands
facility: Merem
city: Hoensbroek
country: Netherlands
facility: Adelante
city: Leiden
country: Netherlands
facility: Basalt
city: Nijmegen
country: Netherlands
facility: Sint Maartenskliniek
city: Tilburg
country: Netherlands
facility: Libra Leijpark
city: Utrecht
country: Netherlands
facility: De Hoogstraat
city: Wijk Aan Zee
country: Netherlands
facility: Heliomare
city: Zwolle
country: Netherlands
facility: Vogellanden
Study officials:
References: