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

Effects of Cerebellar Fastigial Nucleus Electrical Stimulation Combined With Sling Exercise Therapy on Motor Function in Hemiplegic Patients After Stroke

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Cerebellar Fastigial Nucleus Electrical Stimulation; Device: Sling Exercise Therapy

Detailed Description

This study delivers an in-depth technical and mechanistic elaboration of a novel central-peripheral synergistic rehabilitation paradigm for post-stroke hemiplegia, focusing on the combined application of Fastigial Nucleus Stimulation (FNS) and Sling Exercise Training (SET). It primarily expands on the neurophysiological rationale, technical intervention characteristics, synergistic working mechanisms, optimized trial design logic, standardized quality control and core innovative connotations of the combined intervention, avoiding repetitive descriptions of basic trial elements including participant eligibility, outcome measures, sample size calculation and statistical analysis plans. Targeting the key technical bottleneck of conventional post-stroke rehabilitation-non-specific central neural regulation and superficial muscle activation that fails to reverse pathological neural plasticity-this study focuses on the core deficit of cerebello-thalamo-cortical circuit dysfunction and insufficient deep sensorimotor pathway activation, aiming to develop a targeted, high-efficiency combined rehabilitation technical system.

Persistent motor dysfunction after stroke is not limited to superficial limb movement impairment, but essentially stems from defective central motor regulation and disrupted trunk deep sensorimotor integration. Conventional physical therapy mainly concentrates on passive joint protection and superficial limb functional training, which can only prevent secondary complications such as muscle atrophy and joint contractures. However, it lacks targeted modulation of the central balance and motor coordination hub, and cannot reverse stroke-induced neural plasticity inhibition. This leads to persistent deficits in core stability, proprioceptive acuity and dynamic balance, fundamentally restricting the recovery of fine motor skills and daily living function. To address this clinical technical gap, the present study constructs a bidirectional rehabilitation loop integrating precise central neuromodulation and high-sensitivity peripheral sensorimotor training, realizing organic combination of central neural priming and peripheral sensory feedback remodeling.

FNS is a refined, anatomically targeted non-invasive cerebellar neuromodulation technique with unique advantages over broad cortical stimulation modalities. It precisely targets the fastigial nucleus, the core functional node of the cerebellar motor regulatory network, to specifically activate the cerebello-thalamo-cortical neural circuit. This intervention upregulates the excitability of motor-associated cortical regions, enhances local cerebral microperfusion in motor functional areas, and reverses the post-stroke inhibitory state of endogenous neural plasticity. The high-frequency, low-intensity stimulation paradigm adopted in this study is technically optimized for stroke neural repair. It stably induces activity-dependent neural remodeling without triggering cortical over-excitation or neural fatigue, effectively improving the central nervous system's capacity for sensory information integration and precise motor command output, and building a favorable neurophysiological microenvironment for peripheral motor function reconstruction.

SET represents an upgraded sensorimotor integration training technology that breaks the inherent limitations of traditional planar rehabilitation training. By creating an unstable suspension mechanical environment, SET actively triggers autonomous fine regulation of deep trunk stabilizers, including the transversus abdominis and multifidus muscles, which are rarely activated by conventional training methods. The continuous unbalanced mechanical stimulation generated during training elicits high-density proprioceptive afferent signals from trunk and limb muscles, tendons and joints, activates complete human closed kinetic chains, and drives use-dependent functional reorganization of the sensorimotor cortex. Compared with conventional peripheral training, SET significantly improves the accuracy of somatic sensory input and the efficiency of neuromuscular recruitment, serving as a core technical means to improve dynamic balance, trunk control and gait symmetry in post-stroke patients.

The prominent technical innovation of this research lies in the "central priming + peripheral reinforcement" synergistic intervention mechanism, which targets the self-perpetuating pathological vicious cycle of post-stroke motor dysfunction. Central circuit damage after stroke disrupts normal motor command generation, inducing peripheral disuse muscle atrophy and proprioceptive degradation; in turn, distorted peripheral sensory feedback fails to provide effective remodeling stimuli for the central nervous system, further aggravating motor control disorders. The combination of FNS and SET effectively interrupts this pathological cycle. FNS pre-activates and primes the central cerebello-thalamo-cortical pathway to enhance central neural sensitivity to peripheral sensory signals. On this optimized central neural basis, SET delivers high-fidelity, multi-dimensional proprioceptive afferent input, which acts on the primed central circuit, strengthens synaptic connection efficacy via Hebbian plasticity, and produces superposed and amplified therapeutic effects-achieving a genuine synergistic "1+1>2" effect beyond the simple additive efficacy of single interventions.

A rigorous randomized, double-blind, sham-controlled parallel-group design is adopted in this study to ensure objective and accurate verification of the synergistic therapeutic effect, with optimized sham intervention settings to eliminate systematic bias. The sham FNS protocol applies subthreshold low-intensity current that produces identical cutaneous sensory perception without activating neuronal circuits, while sham SET maintains consistent suspension posture and environmental conditions as active training but excludes voluntary neuromuscular contraction. This standardized double sham-control system effectively isolates placebo effects and individual intervention efficacy, enabling accurate differentiation of the independent therapeutic contributions of FNS-mediated central neuromodulation and SET-mediated peripheral sensorimotor training, and providing reliable technical verification for the specific synergistic effect of central-peripheral co-intervention.

All intervention procedures implement unified standardized technical specifications to ensure trial homogeneity and reproducibility. FNS stimulation adopts standardized bilateral mastoid positioning to precisely target fastigial nucleus projection areas, with all stimulation parameters optimized based on existing neuromodulation mechanism evidence to guarantee stable and effective central neural priming. All SET interventions are delivered by professionally certified rehabilitation therapists, with real-time individualized adjustment of training difficulty based on patients' motor control level and fatigue status. The progressive unstable suspension training mode ensures sustained, graded sensorimotor stimulation, avoiding the dual defects of insufficient stimulus intensity and excessive training load existing in fixed conventional training protocols.

A full-process safety and quality control system is established to standardize intervention implementation and protect participant safety. For FNS neuromodulation, real-time sensory monitoring is conducted throughout stimulation sessions; mild adverse reactions such as local tingling and headache are managed by parameter adjustment or temporary stimulation suspension to ensure good neurological tolerance. For SET training, pre-experiment equipment safety inspection and whole-process therapist supervision are mandatory to prevent muscle strain, excessive fatigue and fall risks. Individualized training intensity matching is implemented for patients with different motor function levels to balance training efficacy and safety. All adverse events are recorded in detail and managed hierarchically to ensure standardized and consistent trial implementation.

In summary, this study focuses entirely on technical innovation, neurophysiological mechanisms and synergistic principles of combined central-peripheral rehabilitation, without redundant description of routine trial baseline elements. Its core research value lies in elucidating the synergistic rehabilitation mechanism between fastigial nucleus central neuromodulation and deep core peripheral sensorimotor activation, establishing a standardized, safe and minimally invasive combined rehabilitation technical system, and providing high-level mechanistic and clinical evidence for optimizing individualized rehabilitation strategies for post-stroke hemiplegia.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xue Jiang; Phone Number: +8618940254064; Email: jiangxueruby@163.com
• Study Contact Backup: Name: Mengyuan Yu; Phone Number: +8619537240701; Email: Decads0110@qq.com

Study Locations

• China
  • Shenyang, China
    • Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning 110000
    • Contact: Xue Jiang; Phone Number: +86 189 4025 4064; Email: jiangxueruby@163.com
    • Contact: Mengyuan Yu; Phone Number: +8619537240701; Email: Decads0110@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Met the diagnostic criteria for cerebrovascular disease in Western medicine;
2. Were conscious, with stable vital signs and emotional state;
3. Were male or female, aged 18 to 70 years, with disease onset within the previous 6 months;
4. 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;
5. Were informed about the study and had signed an informed consent form.

Exclusion Criteria:

1. Presence of severe organ dysfunction involving the cardiovascular, pulmonary, liver, or renal systems;
2. Severe joint diseases, incompletely healed fractures, or severe osteoporosis;
3. History of psychiatric illness or severe cognitive, visual, or auditory comprehension impairments that would prevent cooperation with instructions;
4. Concurrent vestibular dysfunction;
5. Unstable vital signs;
6. Patients requiring mechanical ventilation;
7. Contraindications to FNS, such as a history of epilepsy or the presence of intracranial metal foreign bodies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: FNS + sham SET training; FNS: High-precision electrodes were used, with the treatment electrodes placed posterior to the mastoid processes on both sides. The stimulation parameters were set at a frequency of 180 Hz and an intensity of 2 mA for 20 minutes. Sham SET training: Patients were only fixed with non-elastic ropes following the SET training method described above, without performing any movements. This was conducted once daily for 30 minutes.	Device: Cerebellar Fastigial Nucleus Electrical Stimulation; Participants received group-specific interventions 5 days/week for 4 weeks.
Experimental: Group B: sham FNS + SET; Sham FNS: Electrodes were placed in the same position (bilaterally posterior to the mastoid processes). The output was set to a subthreshold intensity (0.1 mA, 180 Hz, 20 min) insufficient to alter neuronal excitability but sufficient to maintain a sense of contact. SET: ① Supine bridge: Patient in supine position, ankles fixed with non-elastic ropes. Patient lifts hips to align with trunk. Hold for 10 s, rest for 5 s; 15 repetitions per set, 2 sets. ② Prone bridge: Patient in prone position, ankles suspended with non-elastic ropes to lift feet off the bed. With therapist assistance, patient lifts hips to maintain a horizontal body position. Hold for approximately 10 s, rest for 5 s; 15 repetitions per set, 2 sets. The exercise difficulty was selected and adjusted in a timely manner based on the patient's condition, performance during training, and subjective feedback.	Device: Sling Exercise Therapy; Participants received group-specific interventions 5 days/week for 4 weeks.
Experimental: Group C: FNS +SET; FNS: High-precision electrodes were used, with the treatment electrodes placed posterior to the mastoid processes on both sides. The stimulation parameters were set at a frequency of 180 Hz and an intensity of 2 mA for 20 minutes. SET: ① Supine bridge: Patient in supine position, ankles fixed with non-elastic ropes. Patient lifts hips to align with trunk. Hold for 10 s, rest for 5 s; 15 repetitions per set, 2 sets. ② Prone bridge: Patient in prone position, ankles suspended with non-elastic ropes to lift feet off the bed. With therapist assistance, patient lifts hips to maintain a horizontal body position. Hold for approximately 10 s, rest for 5 s; 15 repetitions per set, 2 sets. The exercise difficulty was selected and adjusted in a timely manner based on the patient's condition, performance during training, and subjective feedback.	Device: Cerebellar Fastigial Nucleus Electrical Stimulation; Participants received group-specific interventions 5 days/week for 4 weeks.; Device: Sling Exercise Therapy; Participants received group-specific interventions 5 days/week for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 4-weeks treatment
Three-Dimensional Gait	Gait spatiotemporal parameters - Lower limb joint angles - Lower limb joint moments - Ground reaction forces etc.	Baseline, 4-weeks treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 4-weeks treatment

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Investigators: Study Chair: Xue Jiang, Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Motor Function; Cerebellar Fastigial Nucleus Electrical Stimulation; Sling Exercise Therapy; Three-Dimensional Gait
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 2025PS1878K(X1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data will be made available under reasonable request after publication. Data will include de-identified participant data and the data dictionary. Requests can be submitted to the corresponding author. Request will be analyzed and ethical and legal implications of data sharing will be considered. Data will be shared after consent of study participants
• IPD Sharing Time Frame: After publication under reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No