NCT06265766

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
454

participants targeted

Target at P75+ for not_applicable stroke

Timeline
45mo left

Started Dec 2024

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Dec 2024Dec 2029

First Submitted

Initial submission to the registry

January 31, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

December 9, 2024

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

4.3 years

First QC Date

January 31, 2024

Last Update Submit

August 20, 2025

Conditions

Stroke

Keywords

StrokeTranscranial magnetic stimulationContinuous theta burst stimulationUpper limb recoveryTMScTBS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Upper extremity section of the Fugl-Meyer Assessment

    at 12 months post-stroke

  • Action Research Arm Test

    at 90 days and 12 months post-stroke

  • modified Rankin Scale

    at 90 days and 12 months post-stroke

  • Hand section of Stroke Impact Scale

    at 90 days and 12 months post-stroke

  • Participation section of Stroke Impact Scale

    at 90 days and 12 months post-stroke

  • +5 more secondary outcomes

Study Arms (2)

Active cTBS

EXPERIMENTAL

Active cTBS delivered with an active TMS coil

Device: Active cTBS

Sham cTBS

SHAM COMPARATOR

Sham cTBS delivered with a sham TMS coil

Device: Sham cTBS

Interventions

Active cTBSDEVICE

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

Active cTBS
Sham cTBSDEVICE

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

Sham cTBS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Tolbrug

's-Hertogenbosch, Netherlands

NOT YET RECRUITING

Reade

Amsterdam, Netherlands

RECRUITING

Revalidatie Friesland

Beetsterzwaag, Netherlands

RECRUITING

Revant

Breda, Netherlands

RECRUITING

MRC Aardenburg

Doorn, Netherlands

NOT YET RECRUITING

Libra Blixembosch

Eindhoven, Netherlands

RECRUITING

University Medical Center Groningen

Groesbeek, Netherlands

NOT YET RECRUITING

Merem

Hilversum, Netherlands

RECRUITING

Adelante

Hoensbroek, Netherlands

RECRUITING

Basalt

Leiden, Netherlands

RECRUITING

Sint Maartenskliniek

Nijmegen, Netherlands

RECRUITING

Basalt

The Hague, Netherlands

RECRUITING

Libra Leijpark

Tilburg, Netherlands

RECRUITING

De Hoogstraat

Utrecht, Netherlands

RECRUITING

Heliomare

Wijk aan Zee, Netherlands

RECRUITING

Vogellanden

Zwolle, Netherlands

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Jord Vink, PhD

CONTACT

+31634959811j.j.vink-5@umcutrecht.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Sham cTBS treatment is delivered with a sham TMS-coil.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
dr.

Study Record Dates

First Submitted

January 31, 2024

First Posted

February 20, 2024

Study Start

December 9, 2024

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Anonymized patient data can be made available on request

Locations

NL(16)