The Modulatory Effect of Low-intensity Priming Intermittent Theta Burst Stimulation on Motor Cortex Poststroke: a Concurrent TMS-EEG Study

Stroke Clinical Trial

Official title:

The Modulatory Effect of Low-intensity Priming Intermittent Theta Burst Stimulation on Motor Cortex Poststroke: a Concurrent TMS-EEG Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06241508
• Other study ID #: HSEARS20231104003
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: The Hong Kong Polytechnic University
• Contact: Jack Zhang, PhD
• Phone: 27666696
• Email: jack-jq.zhang[@]connect.polyu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: The optimization of the intensity of priming theta burst stimulation increases the probability of success in a randomized controlled trial. We hypothesize that priming intermittent theta burst stimulation (iTBS) with a low-intensity continuous theta burst stimulation (cTBS) will yield superior effects than our original priming protocol in healthy adults and patients after stroke.

Methods: 15 healthy adults and 15 stroke patients will undergo three separate experimental conditions: a low-intensity priming stimulation (55% resting motor threshold [RMT] cTBS+70% RMT iTBS), a conventional-intensity priming stimulation (70% RMT cTBS+70% RMT iTBS), and a nonpriming control. The alterations in cortical excitation/inhibition and its impacts on motor behaviors will be evaluated following stimulation.

Significance: The findings will inform future clinical trials investigating the optimized priming iTBS in promoting poststroke recovery.

Description:

Background: The optimization of the intensity of priming theta burst stimulation increases the probability of success in a randomized controlled trial. We hypothesize that priming intermittent theta burst stimulation (iTBS) with a low-intensity continuous theta burst stimulation (cTBS) will yield superior effects than our original priming protocol in healthy adults and patients after stroke.

Methods: 15 healthy adults and 15 stroke patients will undergo three separate experimental conditions: a low-intensity priming stimulation (55% resting motor threshold [RMT] cTBS+70% RMT iTBS), a conventional-intensity priming stimulation (70% RMT cTBS+70% RMT iTBS), and a nonpriming control. The alterations in cortical excitation/inhibition and its impacts on motor behaviors will be evaluated following stimulation.

Significance: The findings will inform future clinical trials investigating the optimized priming iTBS in promoting poststroke recovery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• (1) have a diagnosis of monohemispheric ischemic or hemorrhagic stroke, with time after stroke onset=6 months;

• (2) aged between 18 and 75 years old;

• (3) with residual upper limb functions from 2-6 levels in the Functional Test for the Hemiplegic Upper Extremity, i.e., moderately impaired overall upper extremity functions.

• (4) able to give informed written consent to participate in the study.

Exclusion Criteria:

• (1) any contraindications to TMS (screened by the safety checklist by Rossi [12]); -

• (2) any concomitant neurological disease;

• (3) any sign of moderate-to-severe cognitive problems, i.e., Montreal cognitive assessment (MoCA)<19/30

• (4) Modified Ashworth score>2 in hand, wrist or elbow extensor muscle in the hemiparetic upper extremity.

In addition, a group of age-matched, right-hand dominant healthy adults without any known neurological diseases will be enrolled. Healthy adults with any contraindications to TMS will be excluded.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Transcranial magnetic stimulation
A standard 600-pulse TBS [16] will be administrated using a MagPro X100 stimulator (MagVenture, Denmark) and a 65-mm figure-of-eight coil. The measurement of the motor hotspot and individual RMT will be in accordance with our established methodology [3, 9]. For patients with stroke, the intensity of real stimulation will be 55% or 70% RMT of the unaffected M1 [17], depending on their assigned condition. Sham stimulation will be delivered using the same coil with 20% RMT of the unaffected M1 [4, 6]. The priming and conditioning sessions will be delivered to the ipsilesional M1 sequentially. In line with previous works, the interval between them will be 10 minutes [2, 3]. For healthy adults, the stimulation will be applied exclusively to the non-dominant (right) M1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The isometric force control task	Force data will be collected using a load cell (Force sensor ZNHM, Chino sensor, China). To assess maximal voluntary contraction (MVC) of the hand grip, three trials will be conducted using both paretic and nonparetic hands (or the dominant and non-dominant hands for healthy controls). Subsequently, separate tests will be performed to measure submaximal isometric force at 20% and 50% of the maximal voluntary force (MVF). Each trial will last for 20 seconds, with a 60-second intertrial interval to prevent fatigue. A total of 5 trials will be conducted for each level of muscle contraction. Muscle strength will be evaluated by calculating the mean force output, while the variability of force control will be assessed by calculating the coefficient of variation of force, i.e., the standard deviation of force/mean force output × 100%.	Baseline
Primary	The isometric force control task	Force data will be collected using a load cell (Force sensor ZNHM, Chino sensor, China). To assess maximal voluntary contraction (MVC) of the hand grip, three trials will be conducted using both paretic and nonparetic hands (or the dominant and non-dominant hands for healthy controls). Subsequently, separate tests will be performed to measure submaximal isometric force at 20% and 50% of the maximal voluntary force (MVF). Each trial will last for 20 seconds, with a 60-second intertrial interval to prevent fatigue. A total of 5 trials will be conducted for each level of muscle contraction. Muscle strength will be evaluated by calculating the mean force output, while the variability of force control will be assessed by calculating the coefficient of variation of force, i.e., the standard deviation of force/mean force output × 100%.	15-min after completion of stimulation sessions
Primary	Transcranial magnetic stimulation-evoked potential	Single pulses evoked an initial response in electroencephalogram, followed by a series of time- and phase-locked positive and negative deflections which could spread to the connected brain areas. The evoked potential is called transcranial magnetic stimulation-evoked potential.	Baseline
Primary	Transcranial magnetic stimulation-evoked potential	Single pulses evoked an initial response in electroencephalogram, followed by a series of time- and phase-locked positive and negative deflections which could spread to the connected brain areas. The evoked potential is called transcranial magnetic stimulation-evoked potential.	5-min after completion of stimulation sessions