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Effects of Individualized iTBS on Upper Limb Function After Stroke

Sponsor
Qilu Hospital of Shandong University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06147167
Collaborator
(none)
159
Enrollment
1
Location
3
Arms
26.5
Anticipated Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical study is to compare the effect of indvidualized intermittent theta burst sitmulation (iTBS) with standard iTBS for post-stroke patients with upper limb impairment. The main questions it aims to answer are:

  1. Whether indvidualized iTBS is better in improving the function of upper limb than that with standard iTBS.

  2. In this study, we want to explore the long-term effect of indvidualized iTBS and standard iTBS.

  3. Functional near-infrared spectroscopy (fNIRS) will be applied in this study to understand the neural mechanism of iTBS in improving upper limb function.

Participants screened as post-stroke upper limb impairment will accept motor function evaluation and fNIRS test before and after treatment, and follow-up. And then randomized divided into three groups: indvidualized iTBS, standard iTBS and sham stimulation.

Researchers will compare the effect of different iTBS mode.We hypothesized that the individualized iTBS will be better in improving the upper limb function post-stroke, and the results will continue at least one month.

Condition or Disease Intervention/Treatment Phase
  • Device: individualized intermittent theta burst sitmulation (iTBS)
  • Device: standard iTBS
  • Device: sham stimulation
 N/A

Detailed Description

This study is a single center, keep patient blind, randomized controlled study. After the patient is enrolled, the upper limb section of the Fugl Meyer Assessment (FMA), the improved RANKIN scale, the Action Research Arm Test (ARAT), and handgrip test are completed as baseline information. And the fNIRS is used to test the brain function to understand the patient's motor network.

Enrolled participants will be randomized divided into three groups, individualized iTBS, standard iTBS and sham stimulation. All the participants received physical therapy, occupational thetapy base on the functional evaluation. The participants have to completed the above test after three-weeks' treatment, and 1 month after the treatment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
159 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Individualized iTBS on Upper Limb Function After Stroke
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Mar 19, 2026
Anticipated Study Completion Date :
Mar 19, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: indvidualized iTBS

In this arm, particaipants will be administered with individualized intermittent theta burst stimulation (iTBS) after encephalography (EEG) test. Three electrode will be placed on the FDI hotspot and record the resting theta frequency and then used as the TBS theta frequency. The participants receive the treatment once a day, five times a week, and total 3 weeks.

Device: individualized intermittent theta burst sitmulation (iTBS)
pariticipants receive individualized iTBS once a day with MagStim stimulator（Rapid2, MagStim, Whiteland, United States）, five days a week and last 3 weeks. In this group, pariticipants receive individualized iTBS protocol, whcih consisted of three pulses of stimulation delivered at 50 Hz, repeated every 200 ms, and delivered in a frequency according to the EEG results and repeated every 10 s for a total of 190 s. The treatment is complemented once a day, five days a week and last 3 weeks, and will be stopped immediately upon occurrence of any discomfort.
Other Names:
  • physical therapy
  • occupational therapy

    		•
    Active Comparator: standard iTBS

    In this arm, participants also received EEG firstn for same procedure. However, iTBS will be delivered with standard theta burst stimulation 5Hz. The participants receive the treatment once a day, five times a week, and total 3 weeks.

    Device: standard iTBS
    MagStim stimulator（Rapid2, MagStim, Whiteland, United States）is used in this study.The iTBS protocol consisted of three pulses of stimulation delivered at 50 Hz, repeated every 200 ms, and delivered in 2-s trains repeated every 10 s for a total of 190 s (total 600 pulses). The treatment was stopped immediately upon occurrence of any discomfort.
    Other Names:
  • physical therapy
  • occupational therapy

    		•
    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 is as the same as the standard iTBS, except that the coil is perpendicular to the scalp.
    Other Names:
  • physical therapy
  • occupational therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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).

    3. handrip test [Befor and after the treatment, and 1 month after the treatment.]

      Hand grip test will be finished with a dynamometer.

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Qilu hospital of Shandong University Jinan Shandong China 250012

    Sponsors and Collaborators

    • Qilu Hospital of Shandong University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Qilu Hospital of Shandong University
    ClinicalTrials.gov Identifier:
    NCT06147167
    Other Study ID Numbers:
    • KYLL-202307-024
    First Posted:
    Nov 27, 2023
    Last Update Posted:
    Nov 27, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Qilu Hospital of Shandong University
    intermittent theta burst stimulation;
    upper extremity paresis;
    functional nearinfrared spectroscopy
    Additional relevant MeSH terms:
    Muscle Weakness
    Stroke
    Paresis

    Study Results

    No Results Posted as of Nov 27, 2023