NCT05968248Not yet recruiting
Efficacy and Safety of Deep Brain Stimulation in Mesencephalic Locomotor Region（MLR） for Poststroke Hemiplegia
A Randomized Controlled Trial Exploring the Efficacy and Safety of Deep Brain Stimulation in the Treatment of Motor Dysfunction After Stroke#the PASTS-Stroke Study#
Source: ClinicalTrials.gov · Last updated 1 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 9 Jul 2023
- Start date
- 10 Sept 2023
- Primary completion date
- 12 Dec 2025
- Lead sponsor
- Chinese PLA General Hospital
- Diseases
- Stroke
- NCT number
- NCT05968248
What you commit to
- Study type: Interventional
- Planned participants: 62
- From 10 Sept 2023 to the primary completion date, 12 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Motor and sensory disturbances are not induced by stroke, nor by previous ischemic stroke, but stroke induced by trauma, brain tumor, etc.
- 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.).
- Participate in another study drug study within 30 days before and during this study.
Other illness
- 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.
- 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.
- Blood system diseases with increased risk of bleeding during surgical intervention.
Other
- 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.
- Unable to complete the basic process, or difficult to maintain compliance and follow-up.
Who the study is looking for
- 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.
- National Institutes of Health Stroke Scale (NIHSS) score from 2 to 20, grades paralyzed muscle strength, between grades 1 and 4, WISCI II, grade \>2 (0-20 items): Assisted by one or more persons, able to walk at least 10 m, and less responsive to conventional rehabilitation prior to inclusion.
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.