LONG TERM EFFECTS OF SPINAL CORD STIMULATION IN PATIENTS WITH PARKINSON'S DISEASE OPEN LABEL EXTENSION TO H-49023
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
Parkinson Disease (PD) patients experience a variety of motor issues such as walking difficulties, loss of balance, and freezing while walking, which impacts their quality of life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically used to treat PD. Current surgical procedures used to alleviate PD symptoms also do not always improve FOG. Since many traditional therapies have failed for the treatment of FOG, researchers have proposed the use of newer treatments. Recent research in animal models and clinical human data using Spinal Cord Stimulation (SCS) has produced promising results, specifically showing improvement in FOG with the use of SCS in patients with PD.
The purpose of this study is to explore the long-term motor and non-motor effects of SCS in PD patients after completing participation on H-49023. The investigators hypothesize that SCS significantly decreases FOG episodes in patients with PD.
- Assess the long-term safety, tolerability and preliminary evidence of effectiveness of upper thoracic spinal cord stimulation for freezing of gait in Parkinson's (PD) patients.
- Allowing patients to choose between the two SCS programming paradigms based on their motor, nonmotor and quality of life measures in PD patients with freezing of gait.
详细描述
Freezing of gait (FOG) is a devastating motor phenomenon which may occur in patients with Parkinson's Disease (PD) and other neurodegenerative disorders. It is characterized by episodes during which patients cannot generate effective forward stepping movements in the absence of motor deficits.
FOG leads to reduced mobility, loss of independence, social embarrassment, and caregiver stress. While most motor features of PD respond robustly to dopaminergic agents and deep brain stimulation (DBS), there are currently no effective treatments for FOG.
Indirect evidence from case reports of PD patients undergoing spinal cord stimulation (SCS) for neuropathic pain, has consistently described a positive effect of SCS on FOG. In addition, two recent reports demonstrated that thoracic SCS improved locomotion and FOG in patients with advanced PD. The promising role of SCS for the treatment of FOG in PD has encouraged us to assemble a multi-disciplinary team for the systematic investigation of the motor effects of SCS on FOG, locomotion and other parkinsonian features.
Patients with PD may be able to undergo SCS implantation through experimental protocols such as study H-49023 (NCT03526991) at BCM. We seek to understand the long-term effects of SCS in PD in patients who have participated in H-49023 at BCM.
The current study will use similar assessments as were used in H-49023. Patients will undergo assessments and questionnaires to help identify which setting and parameters produce the best results for the patient. These questionnaires will asses if the patient fell at home and if any non-motor symptoms arise.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to sign inform consent
- •Underwent SCS implantation as part of participation in H-49023
排除标准
- •Severe dementia Inability to participate in motor or cognitive assessments assessments
结局指标
主要结局
Safety and Tolerability
时间窗: 12-months
Incidence of Adverse Events as assessed by Adverse Event reporting.
次要结局
- Timed 10-meter walk (T10MW)(12month follow up period)
- Gait and Falls Questionnaire (GFQ)(12month follow up period)
- Timed Up and Go test (TUG)(12month follow up period)
- Beck Depression Inventory (BDI-2)(12month follow up period)
- New Freezing of Gait Questionnaire (NFOG-Q) score(12month follow up period)
- Mini-Mental State Examination (MMSE)(12month follow up period)
- Non-Motor Symptoms Scale (NMSS)(12month follow up period)
- MDS-UPDRS score(12month follow up period)
- Montreal Cognitive Assessment Scale (MoCA)(12month follow up period)
- Beck Anxiety Inventory (BAI)(12month follow up period)
- Parkinson's Disease Questionnaire - 39 (PDQ39)(12month follow up period)
研究者
Nora Vanegas
Associate Professors of Neurology
Baylor College of Medicine