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.
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
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.
Parallel
MLR-DBS
Procedure/SurgeryAn 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).
Conventional rehabilitation group
Procedure/SurgeryAn 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).
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.
Overall improvement of clinical symptoms
The NIHSS score is used to evaluate the degree of neurological deficit in stroke patients. The baseline evaluation can assess the severity of stroke, and the treatment effect can be regularly evaluated after treatment. Scores range from 0 to 42, with higher scores indicating more severe neurological damage. ; Patients with a score of 16 are likely to die; A score of 6 was highly likely to have a good recovery, and for each score increase, the probability of a good prognosis decreased by 17%. The grades are as follows: 0-1: normal or nearly normal; Score 1-4: minor stroke; Score 5-15: moderate stroke; 15-20: moderate-to-severe stroke; Scores 21-42: Severe stroke.
Balance ability
The balance ability of the participants during the intervention and follow-up period was assessed by the Biodex Balance System (BBS, USA) \[34\]. Refined tests of balance ability include: (1) Limit of Stability (LOS): Limit of Stability (LOS) is a sensitive and reliable measure of dynamic balance control, which refers to the movement of the torso in the supporting base in eight different directions. The furthest distance you can go without walking. Quantify the results by calculating the ratio of the straight-line distance from the center of gravity to the target point and the actual path length ; (2) Modified Sensory Integration Balance Clinical Test (m-CTSIB): m-CTSIB is an effective and A clinically meaningful sensory tissue measure , which uses the BBS on participants in four conditions (e.g., eyes open-tight surface, eyes closed-tight surface, eyes open-foam surface, and eyes closed-foam surface).
Walking function
Evaluate the space-time parameters such as joint ROM and net muscle moments in the flexion and extension direction of the lower limb joints during self-selected fast walking (such as step length, pace speed, and single support time). Human three-dimensional kinematics and ground reaction forces were acquired by a 10-camera infrared motion capture system (Vicon motion Systems, Oxford, UK) and force platform (Kistler Instruments AG Corp., Switzerland), respectively. A human biomechanical model was established based on Visual 3D (C-Motion, USA), and all gait analysis results were calculated in this software.
Fall risk
The Tinetti Performance Oriented Mobility Assessment (POMA) will be used to assess fall risk during the intervention and follow-up period. A previous study reported that the POMA is an easy-to-administer task-oriented test with a higher test weight than other tests such as the time-to-go test, standing on one leg test, and functional accessibility test. Reliability, discriminant validity and predictive validity . The possible total score is 28 points, with the lower the total score, the greater the risk of falling.
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