Effects of Individualized iTBS on Upper Limb Function After Stroke

April 18, 2024 updated by: Qilu Hospital of Shandong University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: sham iTBS
In this arm, the treatment procedure is similar to the standard iTBS unless the coil is perpendicular to the scalp.
Device: 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.
Other Names:
  • physical therapy
  • occupational therapy
Experimental: indvidualized 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.
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.
Other Names:
  • physical therapy
  • occupational therapy
Active Comparator: 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.
Device: 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.
Other Names:
  • physical therapy
  • occupational therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment-upper extremity
Time Frame: 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.
Befor and after the treatment, and 1 month after the treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin Scale
Time Frame: 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.
Befor and after the treatment, and 1 month after the treatment.
Action Research Arm Test
Time Frame: 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).
Befor and after the treatment, and 1 month after the treatment.
handrip test
Time Frame: Befor and after the treatment, and 1 month after the treatment.
Hand grip test will be finished with a dynamometer.
Befor and after the treatment, and 1 month after the treatment.
functional nearinfrared spectroscopy
Time Frame: 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.
Befor and after the treatment, and 1 month after the treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Investigators

  • Principal Investigator: Yonghui Wang, professor, Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

November 19, 2023

First Submitted That Met QC Criteria

November 19, 2023

First Posted (Actual)

November 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202307-023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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