Safety and Efficacy Study of Implantable Neuromodulation for Poststroke Hemiplegia

NCT06121947 | Not Yet Recruiting

• 1 other identifier: ChinaPLAGH_Xjp1
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Hemiplegia is a common complication after a stroke. Studies have shown that traditional medical and rehabilitation treatments are not good for improving patients' motor function, deep brain stimulation (DBS) and vagus nerve stimulation (VNS) can improve the motor function of patients, but there is no comparative study between them. Objectives: This study compares the efficacy and safety of DBS and VNS in the recovery of motor function in patients with post-stroke hemiplegia, determining the best treatment for patients with post-stroke hemiplegia, and providing high-level clinical evidence for patients and clinicians to choose from. Methods/Design: This is a randomized, double-blind, sham-controlled, cross-controlled pilot study. A total of 98 patients with post-stroke hemiplegia are assigned to receive DBS or VNS. After 3 and 6 months of follow-up, all the devices are turned off. After a 2-week washout, the control group is turned on, but the stimulation group is given sham stimulation. After 9 and 12 months of follow-up, all the devices are turned on. Then, at postoperative 15 and 18 months, postoperative neuroimaging and various post-stroke motor-related scores were performed for data collection and analysis. Discussion: We propose a study design and rationale to compare the efficacy and safety of DBS and VNS in patients with post-stroke hemiplegia to provide evidence and reference for implantable neuromodulation in the treatment of post-stroke dysfunction, and to compare the therapeutic effects of DBS and VNS to provide evidence for patient and clinical diagnosis and treatment choices. Study limitations are related to the small sample size and short study period.

Conditions

Stroke Sequelae; Deep Brain Stimulation; Vagus Nerve Stimulation; Motor Recovery; Stroke; Hemiplegia

Outcome Measures

Primary Outcomes (1)

• Motor function intervention effect: Fugl-Meyer Assessment Scale (FMA)

  Fugl-Meyer Assessment Scale (FMA) was used to measure the motor function of stroke patients. FMA is widely used in clinical motor function assessment and is a quantitative stroke-specific scale used to assess motor function, balance, sensory and joint function in hemiplegic patients. Each of the five domains contains different assessment items, which are scored on a 3-point scale: 0 = unable to perform. 1 = Partially performed, 2 = Fully performed This scale has been found to have good validity and reliability in the stroke population . There are 17 items in total, and the higher the score, the better the motor function.

  Up to 1.5 year postoperatively

Secondary Outcomes (5)

• Overall improvement of clinical symptoms

  Up to 1.5 year postoperatively

• The incidence of surgical complications and side effects

  Up to 1.5 year postoperatively

• Change of 36-item Short Form General Health Survey (SF-36)

  Up to 1.5 year postoperatively

• Change of Hamilton Anxiety Scale (HAMA)

  Time Frame: Six months postoperatively, and one year postoperatively.

• Change of 24-item Hamilton Depression Scale (HAMD)

  Up to 1.5 year postoperatively

Study Arms (2)

The DBS electrodes are implanted into MLR.

EXPERIMENTAL

The DBS electrodes are implanted into MLR.MLR-DBS#Deep brain stimulation of the mesencephalic locomotor region#The arm will be switched on one month postoperatively for electrical stimulation therapy, exercise training rehabilitation, and EMG-triggered neuromuscular stimulation. Specialist doctors will assess the patient's rehabilitation status through the telerehabilitation system every week, and provide, and guide on rehabilitation training and electrical stimulation therapy. Device: GPi-DBS devices DBS electrode: 3387 (Medtronic, Minneapolis, MN, USA) or L302 (PINS Medical, Beijing, China) or 1210(SceneRay, Suzhou, China); Extension wire: 37086 (Medtronic, Minneapolis, MN, USA) or E202 (PINS Medical, Beijing, China) or 1340/SR1341 (SceneRay, Suzhou, China); Implantable pulse generator: ACTIVA PC/RC (Medtronic, Minneapolis, MN, USA) or G102/G102R (PINS Medical, Beijing, China) or 1180/SR1101 (SceneRay, Suzhou, China).

Procedure: The DBS electrodes are implanted into MLR.

The electrodes are implanted into the patient's vagus nerve

ACTIVE COMPARATOR

The electrodes are implanted into the patient's vagus nerve. A pre-surgery assessment was performed. Device implantation was done under general anesthesia. A horizontal neck crease incision was created left of the midline at the level of the cricoid cartilage. After the vagus nerve was identified, the stimulation lead was wrapped around the vagus nerve. The lead was then tunneled subcutaneously to the pulse generator device which was contained in a subcutaneous pocket in the pectoral region

Procedure: The electrodes are implanted into the patient's vagus nerve

Interventions

The DBS electrodes are implanted into MLR. PROCEDURE

MLR-DBS#Deep brain stimulation of the mesencephalic locomotor region#The arm will be switched on one month postoperatively for electrical stimulation therapy,exercise training rehabilitation and EMG-triggered neuromuscular stimulation. Specialist doctors will assess the patient's rehabilitation status through the telerehabilitation system every week, and provide guidance on rehabilitation training and electrical stimulation therapy.

The DBS electrodes are implanted into MLR.

The electrodes are implanted into the patient's vagus nerve PROCEDURE

A pre-surgery assessment was performed. Device implantation was done under general anaesthesia. A horizontal neck crease incision was created left of the midline at the level of the cricoid cartilage. After the vagus nerve was identified, the stimulation lead was wrapped around the vagus nerve. The lead was then tunnelled subcutaneously to the pulse generator device which was contained in a subcutaneous pocket in the pectoral region

The electrodes are implanted into the patient's vagus nerve

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet WHO or international diagnostic criteria for stroke disease;
• The first unilateral supratentorial ischemic or hemorrhagic stroke, the condition is stable after acute treatment of ischemic stroke, the course of disease is 6 months ≤ 1 year, and participate in 2 evaluations (screening and baseline) before enrollment.
• Diagnosed by professional physicians combined with brain CT or magnetic resonance imaging and other imaging techniques;
• Between the ages of 18 and 80, male or female
• The responsible lesion in the unilateral white matter area indicated by cranial CT or MRI
• Relevant sequelae such as limb dysfunction after stroke, accompanied by unilateral limb motor dysfunction, proved to be right-handed by standardized examination.
• Perfect clinical data
• Stable medical and physical condition with adequate nursing support and appropriate medical care in the patient's home community.
• The patient himself or voluntarily signs the informed consent and is willing to cooperate with relevant treatmen

You may not qualify if:

• Glasgow Coma Scale (GSC) score below 15, Minimum Mental State Examination (MMSE) assessment for dementia indicated, suffering from mental disturbance and unable to cooperate with examination or treatment.
• Motor and sensory disturbances are not induced by stroke, nor by previous ischemic stroke, but stroke induced by trauma, brain tumor, etc.
• Serious comorbidities, such as malignant tumors, primary heart, liver, kidney or hematopoietic system diseases.
• History of cognitive impairment, mental disorder, drug abuse, drug allergy, and alcoholism.
• Infection or rupture of the skin on the forearm or leg.
• Possess a pacemaker, metal stent, plate, or implant susceptible to electrical impulses in the body (pacemaker or defibrillator, baclofen pump, deep brain stimulator, Ventricular shunts, shrapnel, etc.).
• Pregnant or breast-feeding or have a recent birth plan.
• IS CLASSROUS.
• Congenital or acquired abnormalities of lower extremities (affecting joints and bones).
• Registration of investigators, their family members, employees, and other dependents.
• Severe joint contractures cause loss or limitation of lower limb activities.
• Blood system diseases with increased risk of bleeding during surgical intervention.
• Participate in another study drug study within 30 days before and during this study.
• Unable to complete the basic process, or difficult to maintain compliance and follow-up

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

Location

Related Publications (1)

• Xu J, Liu B, Shang G, Liu S, Feng Z, Zhang Y, Yang H, Liu D, Chang Q, Yuhan C, Yu X, Mao Z. Deep brain stimulation versus vagus nerve stimulation for the motor function of poststroke hemiplegia: study protocol for a multicentre randomised controlled trial. BMJ Open. 2024 Oct 8;14(10):e086098. doi: 10.1136/bmjopen-2024-086098.

  PMID: 39384245 DERIVED

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhiqi Mao, PhD

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Zhiqi Mao, PhD

CONTACT

8618910155994; markmaoqi@163.com

Study Design

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

Study Record Dates

• First Submitted: October 28, 2023
• First Posted: November 8, 2023
• Study Start: November 10, 2023
• Primary Completion (Estimated): October 30, 2029
• Study Completion (Estimated): October 30, 2030
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

CN (1)