Effects of Individualized iTBS on Upper Limb Function After Stroke

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQilu Hospital of Shandong University

About this trial

The primary objective of this clinical study is to assess the comparative efficacy of individualized intermittent theta burst stimulation (iTBS) in contrast to standard iTBS for individuals post-stroke experiencing upper limb impairment. The key inquiries addressed in this study encompass:

Enhancement of Upper Limb Function: The primary investigation seeks to determine whether individualized iTBS yields superior improvements in upper limb functionality compared to standard iTBS.

Long-Term Effects: This study endeavors to explore the sustained effects of both individualized and standard iTBS on upper limb function over an extended duration.

Neural Mechanisms Investigation: Functional near-infrared spectroscopy (fNIRS) will be employed to elucidate the neural mechanisms underlying the impact of iTBS on the enhancement of upper limb function.

Post-stroke individuals with upper limb impairment will undergo pre-treatment assessments, including motor function evaluations and fNIRS tests. Subsequently, they will be randomized into three groups: individualized iTBS, standard iTBS, and sham stimulation. Participants will undergo post-treatment assessments and follow-up evaluations.

The research team aims to discern disparities in the efficacy of different iTBS modalities. The central hypothesis posits that individualized iTBS will demonstrate superior efficacy in enhancing post-stroke upper limb function, with sustained effects persisting for a minimum of one month.

Eligibility criteria

Qualifiers

aging from 18-80

diagnosed as first-happened stroke,duration of the disease ranged from 1-3 months

upper extremity impairment

with mini-mental state examination>15

Disqualifiers

with stroke history

have metal device within the body

with history of upper extremity trauma,fracture, and/or burn

serious conditions and can not finish the examination and treatment

Trial design

Treatments tested in this trial

  • individualized intermittent theta burst sitmulation (iTBS)
  • standard iTBS
  • sham stimulation

Treatment groups

159 Participants
are divided into 3 treatment groups