MedTrace Logo

Brain STimulation for Arm Recovery After Stroke 2

NCT06265766 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2025-08-27

No results posted yet for this study

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

Conditions

Interventions

DEVICE

Active cTBS

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

DEVICE

Sham cTBS

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

Sponsors & Collaborators

  • Jord Vink

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-09
Primary Completion
2029-03-31
Completion
2029-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06265766 on ClinicalTrials.gov