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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05968248
Other study ID # ChinaPLAGH_Xjp
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 10, 2023
Est. completion date November 11, 2027

Study information

Verified date July 2023
Source Chinese PLA General Hospital
Contact Zhiqi Mao, PhD
Phone 8618910155994
Email markmaoqi@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
MLR-DBS
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).
Conventional rehabilitation group
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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Up to 1 year postoperatively
Secondary 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).
Up to 1 year postoperatively
Secondary 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. Up to 1 year postoperatively
Secondary 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. Up to 1 year postoperatively
Secondary ADL executive ability 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. Up to 1 year postoperatively
Secondary A 36-item short-form questionnaire (SF-36) 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. Up to 1 year postoperatively
Secondary The incidence of surgical complications and side effects 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. Up to 1 year postoperatively
Secondary Hamilton Depression Scale,HAMD 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. Up to 1 year postoperatively
Secondary Acceptability of the intervention 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. Up to 1 year postoperatively
Secondary Hamilton Anxiety Scale (HAMA) 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. Up to 1 year postoperatively
Secondary All adverse events 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). Up to 1 year postoperatively
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