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

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.

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).

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.

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.

Participants' ADL will be assessed by Barthel Index (BI) during the intervention and follow-up period. Previous studies have shown that BI has high internal and internal reliability in the assessment of ADLs in stroke survivors . Business Intelligence consists of 10 items describing different activities; lower scores indicate a higher ADL reliance.

A 36-item short-form questionnaire (SF-36) will be used to assess participants' quality of life. It is easy to use, accepted by patients, and meets strict reliability and validity criteria. The SF-36 is a self-administered questionnaire containing 36 items that measures health on 8 multi-item dimensions; higher scores indicate better health.

Continuously record the subjects' vital signs, physical examination, sleep time and other objective inspection indicators, and compare them before and after the operation; record the improvement of the subjects' subjective symptoms, and compare them before and after the operation.

Hamilton Depression Scale (HAMD), developed by Hamilton in 1960, is the most commonly used scale in clinical assessment of depression. The patients were examined jointly by two trained raters, generally by conversation and observation. After the examination, the two raters scored independently. Scoring reference values: < 7, no depression; 7-17 points, mild depression; 18 to 24 points, moderate depression; > 24, severe depression.

Acceptability of the intervention includes: (1) referral rate - number of referrals by different departments and hospitals divided by all participants (T1); (2) retention rate - participation in completing the study Divide the number of participants (T4) by all participants (T1); (3) dropout rate - the number of dropouts after randomization divided by all participants (T1), interview participants who drop out to determine the reason for their dropout.

The 14-item Hamilton Anxiety Scale (HAMA) was developed by Hamilton in 1959. It is one of the most widely used physician-rated scales in psychiatry. It is mainly used to assess the severity of anxiety symptoms in neurosis and other patients. All items were scored on a 5-point scale from 0 to 4. The criteria for each level were: 0, asymptomatic 1, mild; Score 2, medium; 3 points, heavy; Four points, extremely heavy. The total score ≥29 points, may be severe anxiety; The total score ≥21 points, must have obvious anxiety; Total score ≥14 points, must have anxiety; The total score ≥7 points, may have anxiety; The total score was < 7 and there were no symptoms of anxiety.

All adverse events (such as pain and falls) that occurred during the intervention and follow-up will be recorded on the case record form (CRF) through monitoring and self-reporting, and the relevance of the intervention will be assessed. The incidence of adverse events was defined as the number of patients with occurrence divided by all patients (T1).