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Deep Brain Stimulation clinical trials

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NCT ID: NCT06121947 Not yet recruiting - Stroke Clinical Trials

Safety and Efficacy Study of Implantable Neuromodulation for Poststroke Hemiplegia

Start date: November 10, 2023
Phase: N/A
Study type: Interventional

Background: Hemiplegia is a common complication after a stroke. Studies have shown that traditional medical and rehabilitation treatments are not good for improving patients' motor function, deep brain stimulation (DBS) and vagus nerve stimulation (VNS) can improve the motor function of patients, but there is no comparative study between them. Objectives: This study compares the efficacy and safety of DBS and VNS in the recovery of motor function in patients with post-stroke hemiplegia, determining the best treatment for patients with post-stroke hemiplegia, and providing high-level clinical evidence for patients and clinicians to choose from. Methods/Design: This is a randomized, double-blind, sham-controlled, cross-controlled pilot study. A total of 98 patients with post-stroke hemiplegia are assigned to receive DBS or VNS. After 3 and 6 months of follow-up, all the devices are turned off. After a 2-week washout, the control group is turned on, but the stimulation group is given sham stimulation. After 9 and 12 months of follow-up, all the devices are turned on. Then, at postoperative 15 and 18 months, postoperative neuroimaging and various post-stroke motor-related scores were performed for data collection and analysis. Discussion: We propose a study design and rationale to compare the efficacy and safety of DBS and VNS in patients with post-stroke hemiplegia to provide evidence and reference for implantable neuromodulation in the treatment of post-stroke dysfunction, and to compare the therapeutic effects of DBS and VNS to provide evidence for patient and clinical diagnosis and treatment choices. Study limitations are related to the small sample size and short study period.

NCT ID: NCT05959161 Not yet recruiting - Parkinson Disease Clinical Trials

Study on Brain Network Mechanism of Deep Brain Stimulation for Parkinson's Disease

Start date: August 1, 2023
Phase:
Study type: Observational

As a surgical intervention, DBS can effectively relieve PD tremor, rigidity, bradykinesia and other symptoms. How to better screen patients suitable for DBS treatment and conduct reasonable preoperative and postoperative evaluation is crucial to judge the treatment effect and prognosis. The clinical symptom evaluation of PD patients can be divided into motor symptom evaluation and non-motor symptom evaluation. The motor symptoms of PD patients were evaluated by UPDRS III. The evaluation of non-motor symptoms in PD patients was mainly divided into three aspects: cognitive status, emotional status, and sleep status. Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) were used to assess the cognitive status of PD patients. The Hamilton Depression Scale (HAMD) was used to assess the patients' depression status. The Hamilton Anxiety Scale (HAMA) was used to assess the patients' anxiety status. The PD Sleep Scale 2nd version, The PD Sleep Scale 2nd version, PDSS - 2), and rem Sleep Behavior Disorder Questionnaire (sweet HK) (Rapid Eye Movement Sleep behaviors Disorder Questionnaire - Hong Kong, RBDQ - HK) to assess Sleep conditions.

NCT ID: NCT05197439 Not yet recruiting - Clinical trials for Postoperative Delirium

Dexmedetomidine Prevents Postoperative Delirium After Deep Brain Stimulation in Patients With Parkinson's Disease

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Postoperative delirium (POD) is a common complication, and the incidence of POD after deep brain stimulation(DBS) implementation ranges from 10% to 40%. Previous studies suggested that aging and existing non-motor symptom were independent risk factors for POD after supratentorial tumor resections. Therefore, patients undergoing DBS are high-risk populations for POD. A lot of trials show that dexmedetomidine might help to reduce the incidence of delirium in patients undergoing non-cardiac surgery. However, the impact of dexmedetomidine on POD for patients undergoing DBS was seldom reported. The purpose of this study was to investigate the effect of dexmedetomidine on POD in patients with Parkinson' Disease undergoing DBS.

NCT ID: NCT01274832 Not yet recruiting - Parkinson's Disease Clinical Trials

Prospective Study to Compare Results of STN-DBS Between Early Treated and Late-treated PD Patient

DeBraStE
Start date: February 2011
Phase: N/A
Study type: Observational

The aim of this study is to investigate the impact of DBS not only no motor outcomes, but also on neuropsychological and psychiatric aspects and on quality of life in young patients with a short history of disease.