Effect of Cerebellar Fastigial Nucleus Stimulation Combined With Sling Exercise on Motor Function in Hemiplegic Stroke Patients

ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShengjing Hospital

About this trial

This study aims to investigate the rehabilitative effects and synergistic potential of combining Fastigial Nucleus Stimulation (FNS) with Sling Exercise Training (SET) on motor function in patients with post-stroke hemiplegia. Hemiplegia after stroke often results in unilateral motor impairment, balance dysfunction, and decreased proprioception. Although traditional rehabilitation methods can improve certain functions, they are often limited by insufficient central targeting and inadequate activation of deep core muscles, making it difficult to fundamentally repair damaged motor control circuits. FNS, as a non-invasive neuromodulation technique, can precisely target the fastigial nucleus-a critical hub for motor coordination and balance control-thereby modulating neuroplasticity and promoting regional cerebral blood flow to optimize cortical function. SET, on the other hand, utilizes an unstable sling system to efficiently activate deep core muscles (such as the transversus abdominis and multifidus), enhance proprioceptive input, and promote neural reorganization. Based on the concept of "central regulation-peripheral enhancement," this study hypothesizes that the combination of FNS and SET can create a bidirectional intervention pathway, breaking the vicious cycle between central damage and peripheral dysfunction, and achieving a "1+1\>2" therapeutic effect. This study employs a randomized, double-blind, sham-controlled design and plans to enroll 54 eligible patients with post-stroke hemiplegia (aged 18-70 years, within 6 months of onset). Participants will be randomly assigned to three groups: Group A (FNS + sham SET), Group B (sham FNS + SET), and Group C (FNS + SET). FNS will be delivered using high-precision electrodes placed over the bilateral mastoid regions, with a stimulation frequency of 180 Hz and an intensity of 2 mA (sham stimulation at 0.1 mA) for 20 minutes per session. SET will include supine and prone bridging exercises for 30 minutes per session, while sham SET involves suspension without active movement. All patients will be assessed before and after the intervention using the Berg Balance Scale, Fugl-Meyer Assessment, three-dimensional gait analysis, trunk control test, and proprioceptive measurement instruments. The sample size was calculated based on previous data for lower extremity Fugl-Meyer scores (effect size f = 0.502), with an estimated 20% dropout rate, resulting in a target of 54 participants. The innovation of this study lies in its first-time combination of FNS-a more targeted neuromodulation approach-with SET-a high-intensity sensorimotor integration training-and the use of sham controls to precisely quantify the individual contributions of each intervention and validate the synergistic effect of central-peripheral co-stimulation. Potential risks will be strictly managed: FNS may cause localized tingling or mild headache, which can be addressed by adjusting or pausing stimulation; SET will be conducted under the supervision of trained therapists with individualized intensity adjustments to prevent muscle soreness or falls. All adverse events will be documented and managed promptly. The findings of this study are expected to provide an effective, non-invasive central-peripheral synergistic rehabilitation strategy for post-stroke hemiplegia and offer evidence-based guidance for clinical practice and future research.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Met the diagnostic criteria for cerebrovascular disease in Western medicine;

Were conscious, with stable vital signs and emotional state;

Were male or female, aged 18 to 70 years, with disease onset within the previous 6 months;

Had no significant cognitive or auditory comprehension impairments, were able to understand and execute relevant instructions, and could cooperate with the completion of relevant rehabilitation assessments;

Disqualifiers

Presence of severe organ dysfunction involving the cardiovascular, pulmonary, liver, or renal systems;

Severe joint diseases, incompletely healed fractures, or severe osteoporosis;

History of psychiatric illness or severe cognitive, visual, or auditory comprehension impairments that would prevent cooperation with instructions;

Concurrent vestibular dysfunction;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cerebellar Fastigial Nucleus Electrical Stimulation

    Device

    Participants received group-specific interventions 5 days/week for 4 weeks.

  • Sling Exercise Therapy

    Device

    Participants received group-specific interventions 5 days/week for 4 weeks.

Treatment groups

54 Participants
are divided into 3 treatment groups
Group A: Group A: FNS + sham SET trainingExperimental treatment 1 intervention
Group B: Group B: sham FNS + SETExperimental treatment 1 intervention
Group C: Group C: FNS +SETExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Functional near-infrared spectroscopy

Near-infrared Brain Functional Imaging:The testing areas cover the bilateral prefrontal lobes, motor areas, occipital lobes, and other brain regions. Within 1 week before treatment initiation, a physician will collect resting-state and task-state fNIRS data from enrolled patients.Resting-State Data Collection:The patient is fitted with an fNIRS measurement headcap. In a quiet, comfortable environment, they are instructed to sit, relax, keep eyes closed (without falling asleep), and data are collected for 5 minutes.Task-State Data Collection:A walking paradigm is set up. The test includes a 10-second preparatory phase where the patient stands at rest, followed by the task phase:Upon the command "Please start walking," the subject alternates stepping for 30 seconds.At the command "Stop," they cease walking and stand in place to rest for 30 seconds. This "walk-rest" cycle is repeated 4 times.Identical data collection will be completed within 1 week after treatment concludes.

Time frame
Baseline, 4-weeks treatment
2

Three-Dimensional Gait

Gait spatiotemporal parameters - Lower limb joint angles - Lower limb joint moments - Ground reaction forces etc.

Time frame
Baseline, 4-weeks treatment

Secondary outcomes

1

Fugl Meyer Assessment

The Fugl-Meyer Assessment (FMA) is used to evaluate the lower limb motor function and coordination of research subjects. Modified from the Brunnstrom evaluation method, this scale is divided into two parts: upper limb and lower limb motor function assessment, with only the lower limb subscale (FMA-LE) applied in this study. The FMA-LE consists of 17 items, each graded into three levels (0 points = unable to perform; 1 point = partially performed; 2 points = fully performed), with a total score ranging from 0 to 34. A higher score indicates better lower limb motor function.

Time frame
Baseline, 4-weeks treatment

Other outcomes

Sponsors and contacts

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