Efficacy and Safety of Deep Brain Stimulation in Mesencephalic Locomotor Region（MLR） for Poststroke Hemiplegia

NCT05968248 | Not Yet Recruiting

• 1 other identifier: ChinaPLAGH_Xjp
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

Abstract: Background: The leftover movement disorder of stroke patients is one of the main causes of disability, and there is still no specific solution. Studies have shown that the improvement of movement disorder symptoms in patients receiving DBS is a potential therapy. treatment approach. However, at present, there are few large-sample studies in this area at home and abroad, which cannot well reveal its actual therapeutic effect and safety, and do not fully understand its potential neural mechanisms, so it is impossible to form a unified and standardized treatment standard, which limits its wide application in clinical practice. Objectives: This study aimed to determine the efficacy and safety of hemiplegia recovery after deep brain electrical stimulation in stroke patients with hemiplegia. Methods/Design: This was a double-blind randomized cross-over controlled pilot study in which 62 patients were assigned to receive deep brain stimulation (DBS) and randomized into DBS and control groups using a randomized controlled study approach, DBS group One month after the operation, electrical stimulation was started, and the control group was given sham stimulation treatment. After 3 and 6 months of follow-up, all the machines were turned off. After a 2-week washout period, the control group was turned on, but the DBS group was given sham stimulation. After the 9th and 12th month of follow-up, all patients were given start-up treatment, and neuroimaging and various post-stroke motor-related scores were performed for data collection and analysis. Discussion: The investigators propose a research design and rationale to explore the effectiveness and safety of DBS in patients with post-stroke hemiplegia, and provide evidence and reference for DBS in the treatment of post-stroke dyskinesia. Study limitations are related to the small sample size and short study time period.

Conditions

Stroke Sequelae

Keywords

Deep brain stimulation;; Hemiplegia;; Motor recovery;; Stroke.

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. The primary outcome was the change in FMA-UE score at follow-up 4 weeks after the intervention compared with baseline, and the main comparison was between the DBS group and the sham stimulation.

  Up to 1 year postoperatively

Secondary Outcomes (11)

• Overall improvement of clinical symptoms

  Up to 1 year postoperatively

• Balance ability

  Up to 1 year postoperatively

• Walking function

  Up to 1 year postoperatively

• Fall risk

  Up to 1 year postoperatively

• ADL executive ability

  Up to 1 year postoperatively

Study Arms (2)

MLR-DBS（Deep brain stimulation of the mesencephalic locomotor region）

EXPERIMENTAL

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.

Procedure: MLR-DBS

Conventional rehabilitation group

SHAM COMPARATOR

The arm will l also have DBS surgery and receive the same rehabilitation training under the face-to-face guidance of specialists except for the power-on (sham stimulation, power-on stimulation parameter is 0).

Procedure: Conventional rehabilitation group

Interventions

MLR-DBS PROCEDURE

An elaborate target/trajectory planning and a precise image fusion of MRI and stereotactic CT scanning are performed before surgery. After microelectrode recording, two sets of quadripolar DBS leads (contact interval is 1.5mm) will be inserted into theMLR. Subsequently, an implantable pulse generator will be connected via extension wires and implanted at the left/right subclavicular area subcutaneously. Device: MLR-DBS devices (1) DBS electrode: 3387 (Medtronic, Minneapolis, MN, USA) or L302 (PINS Medical, Beijing, China) or 1210(SceneRay, Suzhou, China); (2) Extension wire: 37086 (Medtronic, Minneapolis, MN, USA) or E202 (PINS Medical, Beijing, China) or 1340/SR1341 (SceneRay, Suzhou, China); (3) Implantable pulse generator: ACTIVA PC/RC (Medtronic, Minneapolis, MN, USA) or G102/G102R (PINS Medical, Beijing, China) or 1180/SR1101 (SceneRay, Suzhou, China).

MLR-DBS（Deep brain stimulation of the mesencephalic locomotor region）

Conventional rehabilitation group PROCEDURE

An elaborate target/trajectory planning and a precise image fusion of MRI and stereotactic CT scanning are performed before surgery. After microelectrode recording, two sets of quadripolar DBS leads (contact interval is 1.5mm) will be inserted into theMLR. Subsequently, an implantable pulse generator will be connected via extension wires and implanted at the left/right subclavicular area subcutaneously.The latter will receive the same rehabilitation training under the face-to-face guidance of specialists except for the power-on (sham stimulation, power-on stimulation parameter is 0).

Conventional rehabilitation group

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 treatment

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

Related Publications (1)

• Xu J, Liu B, Liu S, Feng Z, Zhang Y, Liu D, Chang Q, Yang H, Chen Y, Yu X, Mao Z. Efficacy and safety of deep brain stimulation in mesencephalic locomotor region for motor function in patients with post-stroke hemiplegia: a study protocol for a multi-center double-blind crossover randomized controlled trial. Front Neurol. 2024 Aug 13;15:1355104. doi: 10.3389/fneur.2024.1355104. eCollection 2024.

  PMID: 39193146 DERIVED

MeSH Terms

Conditions

Hemiplegia; Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhiqi Mao, PhD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Junpeng Xu, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Bin Liu, PhD

  Chinese PLA General Hospital

  STUDY CHAIR

• Di Liu, MD

  Chinese PLA General Hospital

  STUDY CHAIR

• Haonan Yang, MD

  Chinese PLA General Hospital

  STUDY CHAIR

• Shufeng Liang, MD

  Chinese PLA General Hospital

  STUDY CHAIR

• Zhebin Feng, MD

  Chinese PLA General Hospital

  STUDY CHAIR

• Jun Hong, MD

  Chinese PLA General Hospital

  STUDY CHAIR

• Rui Hui, MD

  Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Zhiqi Mao, PhD

CONTACT

8618910155994; markmaoqi@126.com

Junpeng Xu, MD

CONTACT

8613144628367; junpengxv@163.com

Study Design

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

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: August 1, 2023
• Study Start: September 10, 2023
• Primary Completion: December 12, 2025
• Study Completion (Estimated): November 11, 2027
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share