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临床试验/NCT07085910
NCT07085910尚未招募不适用

Modulating Interhemispheric Interactions Using Hebbian-Type Associative Stimulation to Promote Upper Extremity Motor Recovery Following Stroke

The Hong Kong Polytechnic University0 个研究点目标入组 108 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
108
主要终点
The Fugl-Meyer Assessment-Upper Extremity Scores

研究概览

简要总结

Stroke remains the primary cause of long-term neurological disabilities. Effective rehabilitation solutions are essential to alleviate the burden poststroke survivors impose on hospitals and community services. Following unilateral stroke, interhemispheric balance is disrupted. Prior studies have extensively documented that exaggerated interhemispheric inhibitory flow from the contralesional to the ipsilesional hemisphere prevents maximal functional recovery in poststroke survivors. Therefore, we aimed to test the modulatory effects of a Hebbian-type plasticity induction paradigm using corticocortical paired associative stimulation (ccPAS) over the bilateral motor cortex. This approach aims to reverse the abnormal inhibitory flow from the contralesional to the ipsilesional hemisphere and assess its clinical benefits on upper extremity motor recovery in patients with stroke. In this randomized controlled trial, we hypothesize that Hebbian-type ccPAS would be more effective than sham ccPAS and conventional single-site inhibitory rTMS delivered to the contralesional hemisphere at improving hemiplegic upper limb motor functionality and modulating interhemispheric activity to an equilibrium state among patients with stroke. This approach seeks to address diseases related to brain network impairments, such as stroke. This project will provide insights into the recovery mechanisms activated following neurological diseases from the perspective of the Hebbian learning rules of associative plasticity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis with monohemispheric ischemic subcortical stroke (with intact corpus callosum), with stroke onset ≥6 months,
  • •Age 40-75 years.
  • •Residual upper limb function between levels 3-6, according to the Functional Test for the Hemiplegic Upper Extremity (FTHUE), indicating mildly to moderately impaired upper limb motor function.
  • •Capable of providing informed written consent.

排除标准

  • •any contraindications for TMS (screened using the safety checklist by Rossi)
  • •Diagnosis of any concomitant neurological diseases other than stroke.
  • •Signs of cognitive impairment, defined as a Montreal cognitive assessment Hong Kong version score <21/22 out of 30 .
  • •Severe spasticity in the hemiparetic upper limb muscles, with a Modified Ashworth score >2.

研究组 & 干预措施

Corticocortical paired associative stimulation (ccPAS)

Experimental

The ccPAS will be applied using two MagPro X100 stimulators connected to two vertically oriented figure-of-eight coils designed for bilateral hemispheric stimulation. Each ccPAS session will involve the delivery of 90 paired pulses, stimulating the M1s over both the contralesional and ipsilesional hemispheres at a frequency of 0.05 Hz. Each session will be 30 minutes, and the interstimulus interval between paired pulses will be 8 ms to ensure that the ipsilesional M1 neurons are always activated before the firing of contralesional M1 neurons.

干预措施: Transcranial magnetic stimulation - dual coil (Device)

Conventional single-site low frequency repetitive transcranial magnetic stimulation (rTMS)

Active Comparator

LF rTMS will be performed using a TMS stimulator and the same stimulation coil (MC-B65-HO). The stimulation target will be set the contralesional M1 area, determined using motor hotspot hunting. In line with our recent trial, a total of 1200 pulses (20 mins) with a frequency of 1 Hz and an intensity of 120% of the RMT will be delivered to the contralesional M1

干预措施: Transcranial magnetic stimulation (Device)

Sham corticocortical paired associative stimulation (ccPAS)

Sham Comparator

The same dual-coil setup (MC-B65-HO) and stimulation intensity during sham stimulation as in the ccPAS group will be utilized. However, the inter-stimulus interval between paired pulses will be adjusted to 100 ms (a duration that prevents any STDP-like effects from being induced by repetitive paired-pulse stimulation)

干预措施: Transcranial magnetic stimulation - dual coil (Device)

结局指标

主要结局

The Fugl-Meyer Assessment-Upper Extremity Scores

时间窗: At 3-month

The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for assessing poststroke upper limb motor control. It is used to determine the movement, coordination, and reflex action of the affected upper limb in poststroke people.

The Fugl-Meyer Assessment-Upper Extremity Scores

时间窗: Baseline

The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for assessing poststroke upper limb motor control. It is used to determine the movement, coordination, and reflex action of the affected upper limb in poststroke people.

The Fugl-Meyer Assessment-Upper Extremity Scores

时间窗: At 4 weeks

The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for assessing poststroke upper limb motor control. It is used to determine the movement, coordination, and reflex action of the affected upper limb in poststroke people.

次要结局

  • Interhemispheric signal propagation (ISP) in TMS-evoked potential(At 4-week)
  • Interhemispheric signal propagation (ISP) in TMS-evoked potential.(At 3-month)
  • Interhemispheric signal propagation (ISP) in TMS-evoked potential(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

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