Optimization of Time Parameters of Priming iTBS for Poststroke Motor Rehabilitation

Not Applicable

Not yet recruiting

• Conditions: Stroke; Stroke Rehabilitation
• Interventions: Device: Theta burst stimulation (TBS); Behavioral: Robot-assisted training

• Registration Number: NCT06612437
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

The goal of this clinical trial is to identify the effect of different time intervals between continuous theta burst stimulation (cTBS) and intermittent theta burst stimulation(iTBS), on top of a standard robot-assisted training (RAT) for sensorimotor rehabilitation in patients with chronic stroke. Using electroencephalography (EEG) to explore potential sensorimotor neuroplasticity underying stroke.

Detailed Description

Delivering Intermittent theta burst stimulation (iTBS) primed with continuous theta burst stimulation (cTBS) to the primary motor cortex (M1) may enhance the facilitatory effect of iTBS on the stimulated M1 through metaplasticity. Previous studies have verified the effectiveness of priming iTBS on improving motor rehabilitation in patients with stroke. However, the optimal time interval between cTBS and iTBS remains unknown. The aim of this clinical trial is to identify the effect of different time intervals between cTBS and iTBS, followed with a standard robot-assisted training (RAT) for sensorimotor rehabilitation in patients with chronic stroke. Using electroencephalography (EEG) to explore potential sensorimotor neuroplasticity. A three-arm randomized controlled trial (RCT) will be performed with an estimated total of 30 patients with chronic stroke. All participants will be randomly allocated to receive 10-session intervention of different TBS protocols (i.e., cTBS-3min interval-iTBS, cTBS-10min interval-iTBS and cTBS-20min interval-iTBS), delivered for 2-4 sessions per week, lasting for 3-4 weeks. All participants will receive a 20-minute standard RAT after each stimulation session. Primary outcome will be Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE). Secondary outcomes will be Action Research Arm Test (ARAT), kinematic outcomes generated during RAT as well as EEG.

Study Timeline

• Study First Submitted: 2024-09-21
• Study First Submitted QC: 2024-09-21
• Study First Posted: 2024-09-25
• Status Verified: 2024-10
• Study Start: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. diagnosis of hemorrhagic or ischemic stroke using computed tomography (CT) or magnetic resonance imaging (MRI).
2. the first-ever stroke with unilateral hemiplegia.
3. 18-75 years old.
4. chronic stroke ( ≥ 6 months).
5. residual hemiparetic upper limb functional level 2-6 in the Functional Test for the Hemiplegic Upper Extremity (FTHUE-HK).
6. can understand and read Chinese.
7. signed informed consent.

Exclusion Criteria

1. diagnosis of any clinically significant or unstable medical disorder.
2. any contraindications to TMS based on the TMS safety guidelines (Rossi, Hallett, Rossini, & Pascual-Leone, 2011).
3. inability to follow treatment instructions due to severe cognitive (using the Hong Kong version of the Montreal Cognitive Assessment (MoCA-HK) < 22/30) and communication deficiency.
4. extreme spasticity over the hemiparetic upper limb (Modified Ashworth Score>2) or severe pain that hindered movement.
5. a history of neurological or psychiatric disease excluding stroke, or current use of psychoactive medication (sedatives, antipsychotics, antidepressants, etc.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Priming iTBS with 10-Minute Interval	Theta burst stimulation (TBS)	experimental interval(10min) between cTBS and iTBS
Priming iTBS with 3-Minute Interval	Theta burst stimulation (TBS)	short interval(3min) between cTBS and iTBS
Priming iTBS with 3-Minute Interval	Robot-assisted training	short interval(3min) between cTBS and iTBS
Priming iTBS with 10-Minute Interval	Robot-assisted training	experimental interval(10min) between cTBS and iTBS
Priming iTBS with 20-Minute Interval	Theta burst stimulation (TBS)	long interval(20min) between cTBS and iTBS
Priming iTBS with 20-Minute Interval	Robot-assisted training	long interval(20min) between cTBS and iTBS

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer assessment of upper extremity (FMA-UE)	Baseline, at the end of treatment, one month after treatmnet	Fugl-Meyer Assessment of upper extremity (FMA-UE) scale is an index to assess the sensorimotor impairment in individuals who have had stroke. It contains motor assessment and sensory assessment. The motor parts includes 33 items assessing the movement, coordination and reflex actions of the shoulder, elbow, forearm and wrist, as well as the hand joints of the paretic arm. Each item consists of a three-point scale (0, 1 and 2), with a total maximum score of 66. The sensory component consists of 6 items assessing light touch and position of the shoulder, elbow, wrist, and thumb. Each item consists of a three-point scale (0, 1, and 2) with a total score of 12 points.

Secondary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT)	Baseline, at the end of treatment, one month after treatmnet	The ARAT is a clinical assessment for upper limb functional activities for patients with stroke, which mainly focuses on the proximal and distal upper limb function. It consists of four subscales: grasp, grip, pinch and gross movement. It has 19 movement tasks, each graded using a four-point scale (total scores range from 0 to 57) (McDonnell, 2008). The MCID of ARAT is 5.70 points (Van der Lee et al., 2001).

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, HK, Hong Kong