Brain STimulation for Arm Recovery After Stroke 2

Stroke Clinical Trial

— B-STARS2  

Official title:

Brain STimulation for Arm Recovery After Stroke 2

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06265766
• Other study ID #: NL85511.041.24
• Secondary ID: 85511
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: February 2024
• Source: UMC Utrecht
• Contact: Jord Vink, PhD
• Phone: +31634959811
• Email: j.j.vink-5[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 454
• Est. completion date: December 31, 2029
• Est. primary completion date: March 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Netherlands	Reade	Amsterdam
Netherlands	Revalidatie Friesland	Beetsterzwaag
Netherlands	Revant	Breda
Netherlands	Tolbrug	Den Bosch
Netherlands	Basalt	Den Haag
Netherlands	MRC Aardenburg	Doorn
Netherlands	Libra Blixembosch	Eindhoven
Netherlands	University Medical Center Groningen	Groesbeek
Netherlands	Merem	Hilversum
Netherlands	Adelante	Hoensbroek
Netherlands	Basalt	Leiden
Netherlands	Sint Maartenskliniek	Nijmegen
Netherlands	Libra Leijpark	Tilburg
Netherlands	De Hoogstraat	Utrecht
Netherlands	Heliomare	Wijk Aan Zee
Netherlands	Vogellanden	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Jord Vink

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper extremity section of the Fugl-Meyer Assessment	The score ranges from 0 to 66 points with a higher score indicating better outcome	at 90 days post-stroke
Secondary	Upper extremity section of the Fugl-Meyer Assessment	The score ranges from 0 to 66 points with a higher score indicating better outcome	at 12 months post-stroke
Secondary	Action Research Arm Test	The score ranges from 0 to 57 points with a higher score indicating better outcome	at 90 days and 12 months post-stroke
Secondary	modified Rankin Scale	The score ranges from 0 to 6 points with a lower score indicating better outcome	at 90 days and 12 months post-stroke
Secondary	Hand section of Stroke Impact Scale	The score ranges from 0 to 25 points with a higher score indicating better outcome	at 90 days and 12 months post-stroke
Secondary	Participation section of Stroke Impact Scale	The score ranges from 0 to 40 points with a higher score indicating better outcome	at 90 days and 12 months post-stroke
Secondary	EuroQol-5D	The score ranges from 0 to 5 points per item with a higher score indicating better outcome	at 90 days and 12 months post-stroke
Secondary	Nine Hole Peg Test	The outcome ranges from 0 to 50 seconds with a shorter outcome indicating better outcome	at 90 days and 12 months post-stroke
Secondary	Ipsilesional corticospinal excitability	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	within 12 hours after the 10th cTBS session
Secondary	iMTA medical consumption and productivity cost questionnaire	These questionnaires aim to identify costs associated with medical consumption and productivity loss of paid work.	at 6 and 12 months post-stroke