Effects of Individualized iTBS on Upper Limb Function After Stroke

Stroke Clinical Trial

Official title:

Effects of Individualized iTBS on Upper Limb Function After Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06147167
• Other study ID #: KYLL-202307-023
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: July 2023
• Source: Qilu Hospital of Shandong University
• Contact: Yonghui Wang, professor
• Phone: 86-18560083581
• Email: yonghuiw6606[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 159
• Est. completion date: September 30, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Stroke
• Upper Extremity Paresis

Intervention

Device:
• individualized intermittent theta burst sitmulation (iTBS)
Participants undergo daily sessions of individualized intermittent theta-burst stimulation (iTBS) administered with the MagStim stimulator (Rapid2, MagStim, Whiteland, United States). The intervention spans five days a week and extends over a three-week period. In this group, participants receive a personalized iTBS protocol comprising three pulses of stimulation delivered at 50 Hz, repeated every 200 ms. The stimulation frequency is tailored based on the electroencephalogram (EEG) results and is administered every 10 seconds, with a total duration of 190 seconds. The treatment is administered once a day for five days a week and continues for three weeks, with an immediate cessation in case of any discomfort. This study design ensures a meticulous and tailored approach to iTBS administration.
• standard iTBS
The MagStim stimulator (Rapid2, MagStim, Whiteland, United States) was employed in the current study. The intermittent theta-burst stimulation (iTBS) protocol utilized three pulses of stimulation delivered at a frequency of 50 Hz, with a repetition rate of every 200 ms. These pulses were organized into 2-second trains, repeated every 10 seconds, resulting in a cumulative duration of 190 seconds (equivalent to a total of 600 pulses). Notably, the administration of the treatment ceased promptly in the event of any participant discomfort.
• sham stimulation
The device and protocol are identical to the standard iTBS, with the only difference being the orientation of the coil, which is perpendicular to the scalp.

Locations

Country	Name	City	State
China	Qilu hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

References & Publications (7)

Cash RFH, Cocchi L, Anderson R, Rogachov A, Kucyi A, Barnett AJ, Zalesky A, Fitzgerald PB. A multivariate neuroimaging biomarker of individual outcome to transcranial magnetic stimulation in depression. Hum Brain Mapp. 2019 Nov 1;40(16):4618-4629. doi: 10.1002/hbm.24725. Epub 2019 Jul 22. — View Citation

Cassidy JM, Wodeyar A, Wu J, Kaur K, Masuda AK, Srinivasan R, Cramer SC. Low-Frequency Oscillations Are a Biomarker of Injury and Recovery After Stroke. Stroke. 2020 May;51(5):1442-1450. doi: 10.1161/STROKEAHA.120.028932. Epub 2020 Apr 17. — View Citation

Ferrarelli F, Phillips ML. Examining and Modulating Neural Circuits in Psychiatric Disorders With Transcranial Magnetic Stimulation and Electroencephalography: Present Practices and Future Developments. Am J Psychiatry. 2021 May 1;178(5):400-413. doi: 10.1176/appi.ajp.2020.20071050. Epub 2021 Mar 3. — View Citation

Ge R, Humaira A, Gregory E, Alamian G, MacMillan EL, Barlow L, Todd R, Nestor S, Frangou S, Vila-Rodriguez F. Predictive Value of Acute Neuroplastic Response to rTMS in Treatment Outcome in Depression: A Concurrent TMS-fMRI Trial. Am J Psychiatry. 2022 Jul;179(7):500-508. doi: 10.1176/appi.ajp.21050541. Epub 2022 May 18. — View Citation

Klooster DCW, Ferguson MA, Boon PAJM, Baeken C. Personalizing Repetitive Transcranial Magnetic Stimulation Parameters for Depression Treatment Using Multimodal Neuroimaging. Biol Psychiatry Cogn Neurosci Neuroimaging. 2022 Jun;7(6):536-545. doi: 10.1016/j.bpsc.2021.11.004. Epub 2021 Nov 17. — View Citation

Kong G, Wei L, Wang J, Zhu C, Tang Y. The therapeutic potential of personalized connectivity-guided transcranial magnetic stimulation target over group-average target for depression. Brain Stimul. 2022 Sep-Oct;15(5):1063-1064. doi: 10.1016/j.brs.2022.07.054. Epub 2022 Aug 2. No abstract available. — View Citation

Siddiqi SH, Trapp NT, Shahim P, Hacker CD, Laumann TO, Kandala S, Carter AR, Brody DL. Individualized Connectome-Targeted Transcranial Magnetic Stimulation for Neuropsychiatric Sequelae of Repetitive Traumatic Brain Injury in a Retired NFL Player. J Neuropsychiatry Clin Neurosci. 2019 Summer;31(3):254-263. doi: 10.1176/appi.neuropsych.18100230. Epub 2019 Apr 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment-upper extremity	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.	Befor and after the treatment, and 1 month after the treatment.
Secondary	modified Rankin Scale	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.	Befor and after the treatment, and 1 month after the treatment.
Secondary	Action Research Arm Test	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).	Befor and after the treatment, and 1 month after the treatment.
Secondary	handrip test	Hand grip test will be finished with a dynamometer.	Befor and after the treatment, and 1 month after the treatment.
Secondary	functional nearinfrared spectroscopy	The functional nearinfrared spectroscopy (fNIRS) is used to explore the motor network of the participants.	Befor and after the treatment, and 1 month after the treatment.