Clinical trial NCT06612437: Optimization of Time Parameters of Priming iTBS for Poststroke Motor Rehabilitation
Official title: Optimization of Time Parameters of Priming iTBS for Poststroke Motor Rehabilitation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Stroke Rehabilitation
Keywords: Stroke
TMS
TBS
EEG
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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, \&amp;amp; 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) \&amp;lt; 22/30) and communication deficiency.
4. extreme spasticity over the hemiparetic upper limb (Modified Ashworth Score\&amp;gt;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.).

Primary outcomes:
measure: Fugl-Meyer assessment of upper extremity (FMA-UE)
timeFrame: Baseline, at the end of treatment, one month after treatmnet
Secondary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: Baseline, at the end of treatment, one month after treatmnet
Other outcomes:
measure: Sensorimotor event-related desynchronization
timeFrame: From enrollment to the end of treatment at 4 weeks, as well as one month post treatment
measure: Magnetic sensory evoked potential
timeFrame: Baseline, post one session, at the end of treatment, one month after treatmnet
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
state: HK
Study officials:
References:
citation: Zhang JJ, Bai Z, Fong KNK. Priming Intermittent Theta Burst Stimulation for Hemiparetic Upper Limb After Stroke: A Randomized Controlled Trial. Stroke. 2022 Jul;53(7):2171-2181. doi: 10.1161/STROKEAHA.121.037870. Epub 2022 Mar 23.