LONG TERM EFFECTS OF SPINAL CORD STIMULATION
- Conditions
- Parkinson Disease
- Registration Number
- NCT06272955
- Lead Sponsor
- Nora Vanegas
- Brief Summary
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.
1. 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.
2. 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 10
- Ability to sign inform consent
- Underwent SCS implantation as part of participation in H-49023
- Severe dementia Inability to participate in motor or cognitive assessments assessments
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and Tolerability 12-months Incidence of Adverse Events as assessed by Adverse Event reporting.
- Secondary Outcome Measures
Name Time Method Timed 10-meter walk (T10MW) 12month follow up period The 10-meter walk measures gait velocity. The 10-meter walk is measured in the length of time duration taken to complete. A lower duration means a higher gait speed. A high duration means a lower gain speed.
Gait and Falls Questionnaire (GFQ) 12month follow up period The Gait and Falls Questionnaire (GFQ) is a clinician-administered tool that aims to assess the specific time when the person experiences freezing of Gait as well as how often they fall. The task ratings and scales are calculated into a summed GFQ score. The scale is scored from 0-64. A score of 0 means least severe. A score of 64 means the most severe.
Timed Up and Go test (TUG) 12month follow up period The Timed Up and Go test measures gait velocity. The Timed Up and Go test is measured in the length of time duration taken to complete. A lower duration means a higher gait speed. A high duration means a lower gain speed.
Beck Depression Inventory (BDI-2) 12month follow up period The Beck Depression Inventory (BDI-2) is a 21-item, self-report rating inventory that measures characteristic, attitudes, and symptoms of depression during the past 2 weeks. The score range is 0-63. A total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
New Freezing of Gait Questionnaire (NFOG-Q) score 12month follow up period The New Freezing of Gait Questionnaire (NFOG-Q) is a clinician-administered tool that aims to assess both the clinical aspects of FOG as well as its subsequent impairments on quality of life. The task ratings and scales are calculated into a summed NFOG-Q score. The scale is scored from 0-28. A score of 0 means least severe. A score of 28 means the most severe.
Mini-Mental State Examination (MMSE) 12month follow up period This is a test of cognitive function used to screen and track cognitive changes over time. The MMSE is scored between 0 - 30 which 0 meaning there is an abnormal amount of cognitive function and 30 meaning there is a normal amount of cognitive function.
Non-Motor Symptoms Scale (NMSS) 12month follow up period Symptoms assessed over the last month. Each symptom scored with respect to: Severity: 0 = None, 1 = Mild: symptoms present but causes little distress or disturbance to patient; 2 = Moderate: some distress or disturbance to patient; 3 = Severe: major source of distress or disturbance to patient. The measure is scored between 0 - 360, with 0 meaning there are no non-motor symptoms and 360 meaning there are non-motor symptoms.
MDS-UPDRS score 12month follow up period The Movement Disorder Society (MDS) published a revision of the unified Parkinson's disease rating scale, known as the MDS-UPDRS. The Part III: Motor Examination portion of the scale assesses the motor signs of PD and is completed by the examiner. The measure is scored between 0-76 with 0 have the most abnormal motor signs and 76 having normal motor signs.
Montreal Cognitive Assessment Scale (MoCA) 12month follow up period This is a test of cognitive function used to screen and track cognitive changes over time. The MoCA is scored between 0 - 30 which 0 meaning there is an abnormal amount of cognitive function and 30 meaning there is a normal amount of cognitive function.
Beck Anxiety Inventory (BAI) 12month follow up period The BAI is a 21 self-reported items questionnaire that assess the intensity of physical and cognitive anxiety symptoms during the past week. The score range is 0-63. A total score of 0-7 is considered minimal range, 8-15 is mild, 16-25 is moderate, and 26-63 is severe.
Parkinson's Disease Questionnaire - 39 (PDQ39) 12month follow up period The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality of life. The measure is scored between 0 - 100 with 0 meaning no health problems and 100 meaning more health problems.
Trial Locations
- Locations (1)
Baylor College of Medicine
🇺🇸Houston, Texas, United States