Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04137146
Other study ID # 2019 SNS for gait disturbance
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date May 31, 2021

Study information

Verified date October 2019
Source Ruijin Hospital
Contact Dianyou Li, MD
Phone +8613817864569
Email ldy11483@rjh.com.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Parkinson's disease (PD) is a progressive disease, characterized by dopaminergic neurons degeneration in the substantia nigra. Postural and gait disorders usually occur in advanced PD patients. However, existing drugs and deep brain stimulation (DBS) therapy are not effective enough for these axial symptoms or cannot maintain long-term efficacy, which seriously reduce patients' quality of life. Sacral nerve stimulation(SNS) is a treatment for urinary symptoms in PD. It has been reported that SNS can also improve PD gait disturbance, but the level of evidence currently is low. We assume that SNS may have a similar mechanism to spinal cord stimulation and may be an effective treatment for PD gait disorder. However, there are few studies on the mechanism of SNS treatment. Therefore, we will conduct a large sample, prospective case-control study to provide a higher level of clinical evidence for sacral nerve stimulation in the treatment of gait disturbance in PD. Our primary objective is to evaluate the efficacy of SNS for gait disorder in PD. PD patients who have received DBS surgery but still have severe gait problems will be included. This study will contribute to evaluate the efficacy of SNS for gait disorder in PD, provide level II evidence for expanding the indications of SNS, varicocelectomy., and improve patients' quality of life.


Recruitment information / eligibility

Status Recruiting
Enrollment 6
Est. completion date May 31, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers No
Gender All
Age group 45 Years to 70 Years
Eligibility Inclusion Criteria:

- Idiopathic Parkinson's disease, Hoehn & Yahr stage (medication off condition) at 2~4;

- Gait and balance disorder, unstable posture, frequently falls (gaze and fall questionnaire (GFQ) score > 32) and severe dysuria, extremely affects quality of life (overactive bladder score (OABSS) =12);

- SCS eligibility has been confirmed by neurologist and neurosurgeon;

- Patients willingly seek surgical treatment for PD gait disturbance;

- Ability to perform a gait/walking task (under close supervision);

- Informed consent and have good compliance.

Exclusion Criteria:

- Lesion in spinal nerve or other surgical contraindications;

- Severe depression (Beck Depression Inventory scores > 25) or dementia (Mini Mental State Examination < 24);

- Medical history of stroke, amyotrophic lateral sclerosis or myasthenia gravis;

- Other neuropsychiatric disorders or relevant medical history;

- Taking prohibited medications (such as lithium, valproate, steroids, adrenergic agonists, etc.);

- Cardiac, renal or other important organs hypofunction or dysfunction, or unstable vital signs;

- Women reporting that they are pregnant;

- Any situation (medical, psychological, social, geographical, etc.) that may endanger patient's life or result in patients withdrawing from the study at present or in the future.

Study Design


Intervention

Device:
Sacral Nerve Stimulation
Implantation of a sacral nerve neurostimulation system: A single electrode (Interstim® model 3889-28; Medtronic, Minneapolis, MN) was inserted bilaterally into the sacral foramen (S3), connected to an internal pulse generator (Medtronic Interstim ® II 3058)

Locations

Country Name City State
China Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Zhang C, Wang L, Pan Y, Sun B, Nonnekes J, Bloem BR, Li D. Sacral nerve stimulation improves gait in Parkinson's disease. Brain Stimul. 2019 Jul - Aug;12(4):1075-1076. doi: 10.1016/j.brs.2019.03.074. Epub 2019 Apr 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Parameter changes in Timed Up and Go Test Patients should stand up from the chair, walk forward for 3m with daily speed, turn after passing the marked line, and then walk back to the chair and sit down, leaning back in the chair. Video recordings will be made throughout the test. Baseline (preoperative), during external test stimulation (1-14 days after electrode implantation), 3 months post-SNS
Secondary Changes in Uni?ed Parkinson's Disease Rating Scale Part ? (UPDRS ?) scores Uni?ed Parkinson's Disease Rating Scale Part ? (UPDRS ?) measures the motor severity of Parkinson's disease. UPDRS ? score has a range of 0 (no symptoms) to 132 (severe disease symptoms). Baseline (preoperative), 3 months post-SNS
Secondary Changes in Gait and Fall Questionnaire (GFQ) scores GFQ is a subjective scale for gait problems in the past 4 weeks. GFQ score has a range of 0 (no gait problems) to 64 (severe gait problems) Baseline (preoperative), 3 months post-SNS
Secondary Changes in Berg Balance scale (BBS) scores BBS measures patients' static and dynamic balance abilities. BBS score has a range of 0 (severe balance problems) to 56 (no balance problems). Baseline (preoperative), 3 months post-SNS
Secondary Changes in 8-item Parkinson's Disease Questionnaire (PDQ-8) scores PDQ-8 is a reliable and feasible tool for the assessment of quality of life in Parkinson's disease patients. Baseline (preoperative), 3 months post-SNS
Secondary Changes in EuroQol-5 Dimensions (EQ-5D) scores EQ-5D measures five dimensions of PD patients' quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Baseline (preoperative), 3 months post-SNS
Secondary Changes in Montreal cognitive assessment (MoCA) scores The MoCA is a widely used screening assessment for detecting cognitive impairment. MoCA score has a range of 0 (severe dementia) to 30 (cognitive intact). Baseline (preoperative), 3 months post-SNS
Secondary Changes in Voiding Diary The voiding diary recording the patient's daily fluid input and urinary output is a simple but effective tool for assessing storage symptoms. Baseline (preoperative), during external test stimulation (1-14 days after electrode implantation), 3 months post-SNS
Secondary Parameter changes in Dual task The protocol requires patient to walk along a walkway of 5 m between two retroreflective markers placed 0.5 m. They are asked to make a left or right turn of 360° around the marker before walking further. They are instruted to complete the task with or without a verbal cognitive color classification task. Baseline (preoperative), 3 months post-SNS
Secondary Parameter changes in Six-Minute Walking Test This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. Baseline (preoperative), 3 months post-SNS
Secondary Parameter changes in Rapid 360° Turn The test requires patients to make rapid 360° turns on the spot in both directions. Baseline (preoperative), 3 months post-SNS
See also
  Status Clinical Trial Phase
Completed NCT05415774 - Combined Deep Brain Stimulation in Parkinson's Disease N/A
Recruiting NCT04691661 - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease Phase 2
Active, not recruiting NCT05754086 - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed NCT04045925 - Feasibility Study of the Taïso Practice in Parkinson's Disease N/A
Recruiting NCT04194762 - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation N/A
Completed NCT02705755 - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05830253 - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Recruiting NCT06139965 - Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
Completed NCT04580849 - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease N/A
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Completed NCT03980418 - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam N/A
Completed NCT04942392 - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic N/A
Terminated NCT03446833 - LFP Beta aDBS Feasibility Study N/A
Completed NCT03497884 - Individualized Precise Localization of rTMS on Primary Motor Area N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT04997642 - Parkinson's Disease and Movement Disorders Clinical Database
Completed NCT04117737 - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson N/A
Recruiting NCT03618901 - Rock Steady Boxing vs. Sensory Attention Focused Exercise N/A