Clinical trial NCT06147167: Effects of Individualized iTBS on Upper Limb Function After Stroke
Official title: Effects of Individualized iTBS on Upper Limb Function After Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Upper Extremity Paresis
Stroke
Keywords: intermittent theta burst stimulation;
upper extremity paresis;
functional nearinfrared spectroscopy
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This research constitutes a single-center, double-blind, randomized controlled study. Upon enrollment, baseline information is established through the assessment of upper limb function using the Fugl Meyer Assessment (FMA), the modified Rankin Scale, the Action Research Arm Test (ARAT), and a handgrip test. Additionally, functional near-infrared spectroscopy (fNIRS) is employed to assess brain function, providing insights into the patient's motor network.

Participants in the study are randomly assigned to one of three groups: individualized iTBS, standard iTBS, and sham stimulation. All participants undergo physical therapy and occupational therapy tailored to their functional evaluation. After three weeks of treatment, participants are required to complete the aforementioned assessments, with a follow-up evaluation scheduled one month post-treatment.

Eligibility criteria: Inclusion Criteria:

1. aging from 18-80
2. diagnosed as first-happened stroke,duration of the disease ranged from 1-3 months
3. upper extremity impairment
4. with mini-mental state examination\>15
5. agree to participate in this study and sigh the informed consent

Exclusion Criteria:

1. with stroke history
2. have metal device within the body
3. with history of upper extremity trauma,fracture, and/or burn
4. serious conditions and can not finish the examination and treatment

Primary outcomes:
measure: Fugl-Meyer Assessment-upper extremity
timeFrame: Befor and after the treatment, and 1 month after the treatment.
Secondary outcomes:
measure: modified Rankin Scale
timeFrame: Befor and after the treatment, and 1 month after the treatment.
measure: Action Research Arm Test
timeFrame: Befor and after the treatment, and 1 month after the treatment.
measure: handrip test
timeFrame: Befor and after the treatment, and 1 month after the treatment.
measure: functional nearinfrared spectroscopy
timeFrame: Befor and after the treatment, and 1 month after the treatment.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yonghui Wang, professor
role: PRINCIPAL_INVESTIGATOR
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