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

August 20, 2025 updated by: Jord Vink

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

454

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • 's-Hertogenbosch, Netherlands
        • Not yet recruiting
        • Tolbrug
        • Contact:
          • Cynthia Klinkers
      • Amsterdam, Netherlands
      • Beetsterzwaag, Netherlands
      • Breda, Netherlands
        • Recruiting
        • Revant
        • Contact:
          • Marissa Riemens
      • Doorn, Netherlands
        • Not yet recruiting
        • MRC Aardenburg
        • Contact:
          • Lisa Kruisheer
      • Eindhoven, Netherlands
        • Recruiting
        • Libra Blixembosch
        • Contact:
          • Daphne Stranders
      • Groesbeek, Netherlands
        • Not yet recruiting
        • University Medical Center Groningen
        • Contact:
          • Henk Meulenbelt
      • Hilversum, Netherlands
        • Recruiting
        • Merem
        • Contact:
          • Maijke van Bloemendaal
        • Contact:
          • Karin Peek
      • Hoensbroek, Netherlands
      • Leiden, Netherlands
        • Recruiting
        • Basalt
        • Contact:
          • Annelies Mantje
      • Nijmegen, Netherlands
        • Recruiting
        • Sint Maartenskliniek
        • Contact:
          • Nelleke Kooiman
      • The Hague, Netherlands
      • Tilburg, Netherlands
        • Recruiting
        • Libra Leijpark
        • Contact:
          • Iris Habets
      • Utrecht, Netherlands
        • Recruiting
        • De Hoogstraat
        • Contact:
          • Mirjam Kouwenhoven
      • Wijk aan Zee, Netherlands
        • Recruiting
        • Heliomare
        • Contact:
          • Deborah Wit
      • Zwolle, Netherlands
        • Recruiting
        • Vogellanden
        • Contact:
          • Bente Visser

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active cTBS
Active cTBS delivered with an active TMS coil
Device: Active cTBS
10 sessions of active cTBS delivered to the contralesional primary motor cortex, started within 3 weeks after stroke.
Sham Comparator: Sham cTBS
Sham cTBS delivered with a sham TMS coil
Device: Sham cTBS
10 sessions of sham cTBS delivered to the contralesional primary motor cortex, started within 3 weeks after stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 90 days post-stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 12 months post-stroke
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
at 90 days and 12 months post-stroke
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
at 90 days and 12 months post-stroke
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
at 90 days and 12 months post-stroke
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
at 90 days and 12 months post-stroke
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
at 90 days and 12 months post-stroke
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
at 90 days and 12 months post-stroke
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
within 12 hours after the 10th cTBS session
iMTA medical consumption questionnaire
Time Frame: at 6 and 12 months post-stroke
This questionnaire aims to identify costs associated with medical consumption
at 6 and 12 months post-stroke
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.
At 6 and 12 months post-stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jord Vink

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2024

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL85511.041.24
  • 85511 (Other Identifier: ABR number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Anonymized patient data can be made available on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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