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

NCT07670936 | Not Yet Recruiting

• 1 other identifier: 2025PS1878K(X1)
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Stroke; Cerebellar Fastigial Nucleus Electrical Stimulation; Sling Exercise Therapy; Three-Dimensional Gait; Motor Function

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Fugl Meyer Assessment

  Baseline, 4-weeks treatment

Study Arms (3)

Group A: FNS + sham SET training

EXPERIMENTAL

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

Group B: sham FNS + SET

EXPERIMENTAL

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

Group C: FNS +SET

EXPERIMENTAL

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; Device: Sling Exercise Therapy

Interventions

Cerebellar Fastigial Nucleus Electrical Stimulation DEVICE

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

Group A: FNS + sham SET training; Group C: FNS +SET

Sling Exercise Therapy DEVICE

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

Group B: sham FNS + SET; Group C: FNS +SET

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Were informed about the study and had signed an informed consent form.

You may not qualify if:

• 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;
• Unstable vital signs;
• Patients requiring mechanical ventilation;
• Contraindications to FNS, such as a history of epilepsy or the presence of intracranial metal foreign bodies.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning 110000

Shenyang, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xue Jiang

  Shengjing Hospital

  STUDY CHAIR

Central Study Contacts

Xue Jiang

CONTACT

+8618940254064; jiangxueruby@163.com

Mengyuan Yu

CONTACT

+8619537240701; Decads0110@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication under reasonable request.

Locations

CN (1)