Effects of Individualized iTBS on Upper Limb Function After Stroke
- Conditions
- Upper Extremity ParesisStroke
- Interventions
- Device: individualized intermittent theta burst sitmulation (iTBS)Device: sham stimulationDevice: standard iTBS
- Registration Number
- NCT06147167
- Lead Sponsor
- Qilu Hospital of Shandong University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 159
- 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
- agree to participate in this study and sigh the informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description indvidualized iTBS individualized intermittent theta burst sitmulation (iTBS) 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. sham iTBS sham stimulation In this arm, the treatment procedure is similar to the standard iTBS unless the coil is perpendicular to the scalp. standard iTBS standard iTBS 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.
- Primary Outcome Measures
Name Time Method Fugl-Meyer Assessment-upper extremity Befor and after the treatment, and 1 month after the treatment. Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had stroke. The FMA motor assessments for the upper fucntion with maximum score 66 points, including relflex activity, flexor synergy, extensor synergy, movement combining synergies, movement out of synergy,normal reflex, wrist function, hand function and coordination/speed, and sensory assessment.
- Secondary Outcome Measures
Name Time Method modified Rankin Scale Befor and after the treatment, and 1 month after the treatment. The Modified Rankin Scale (mRS) assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death.
handrip test Befor and after the treatment, and 1 month after the treatment. Hand grip test will be finished with a dynamometer.
Action Research Arm Test Befor and after the treatment, and 1 month after the treatment. The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations.Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).
functional nearinfrared spectroscopy Befor and after the treatment, and 1 month after the treatment. The functional nearinfrared spectroscopy (fNIRS) is used to explore the motor network of the participants.
Trial Locations
- Locations (1)
Qilu hospital of Shandong University
🇨🇳Jinan, Shandong, China