Effects of Individualized iTBS on Upper Limb Function After Stroke

Shandong University

Status: Not yet enrolling

Conditions: Stroke; Upper Extremity Paresis

Treatments: Device: sham stimulation; Device: individualized intermittent theta burst sitmulation (iTBS); Device: standard iTBS

Study type: Interventional

Funder types: Other

Identifiers

NCT06147167

KYLL-202307-023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 159 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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159 participants in 3 patient groups

indvidualized iTBS

Experimental group

Description:

In this arm of the study, participants undergo individualized intermittent theta burst stimulation (iTBS) subsequent to encephalography (EEG) testing. Three electrodes are strategically positioned on the first dorsal interosseous (FDI) hotspot to record the resting theta frequency, which is subsequently utilized as the theta frequency for theta burst stimulation (TBS). The participants receive this treatment regimen once daily, five times a week, over a total duration of three weeks.

Treatment:

Device: individualized intermittent theta burst sitmulation (iTBS)

standard iTBS

Active Comparator group

Description:

In this particular arm of the study, participants also undergo an initial electroencephalography (EEG) procedure. Subsequently, intermittent theta burst stimulation (iTBS) is administered using the standard theta burst stimulation frequency of 5Hz. The participants receive this treatment once daily, five times a week, over a total duration of three weeks.

Treatment:

Device: standard iTBS

sham iTBS

Sham Comparator group

Description:

In this arm, the treatment procedure is similar to the standard iTBS unless the coil is perpendicular to the scalp.

Treatment:

Device: sham stimulation