Adaptive SCS for Treatment of Gait Disturbance in PD

NCT04538131 | Unknown FDA Device

• 1 other identifier: 2020 Adaptive SCS PD Gait
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal cord stimulation (SCS) has been suggested by several research for treating PD gait disturbance. However, the side effects induced by body position change cannot fully addressed by conventional SCS. Medtronic sensor-driven position-adaptive SCS are capable to monitor the position change and change the parameters accordingly, so as to reduce the position change related side effects. Nevertheless, neither the efficacy nor safety of this technique in the treatment of gait disturbance in PD is ever investigated. Therefore, the investigators will conduct a randomized clinical trial to investigate the clinical efficacy and safety of sensor-driven position-adaptive SCS in the treatment of gait disturbance in PD. This study will contribute to find out the safety and efficacy of sensor-driven position-adaptive SCS in the treatment of PD gait disorder, improve patients' quality of life, and reduce the burden on family and society.

Conditions

Gait Disorders, Neurologic; Parkinson Disease

Outcome Measures

Primary Outcomes (4)

• 6-min walk test during the first week (6MWT-1W)

  The 6-min walk test is a test walking over a span of 6 minutes. Gait characters are recorded for further analysis.

  1 week follow-up

• timed up-and-go task during the first week (TUG-1W)

  The Timed Up and Go (TUG) test is a performance-based measure of functional mobility that was initially developed to identify mobility and balance impairments in older adults. Gait characters are recorded for further analysis.

  1 week follow-up

• 6-min walk test during the second week (6MWT-2W)

  The 6-min walk test is a test walking over a span of 6 minutes. Gait characters are recorded for further analysis.

  2 week follow-up

• timed up-and-go task during the second week (TUG-2W)

  The 6-min walk test is a test walking over a span of 6 minutes. Gait characters are recorded for further analysis.

  2 week follow-up

Secondary Outcomes (5)

• EuroQol 5-Dimension, 5-Level Health Scale(EQ-5D-5L)

  1 and 2 week follow-up

• Gait and Fall Questionnaire(GFQ)

  1 and 2 week follow-up

• Modified Fall Efficacy Scale(MFES)

  1 and 2 week follow-up

• Activities-specific Balance Confidence (ABC) scale

  1 and 2 week follow-up

• Survey of Activities and Fear of Falling in the Elderly (SAFFE )

  1 and 2 week follow-up

Study Arms (2)

conventional SCS

ACTIVE COMPARATOR

Device: conventional SCS

sensor-driven position-adaptive SCS

EXPERIMENTAL

Device: sensor-driven position-adaptive SCS

Interventions

sensor-driven position-adaptive SCS DEVICE

Medtronic sensor-driven position-adaptive SCS is capable to monitor the position change and change the parameters accordingly, so as to reduce the position change related side effects.

sensor-driven position-adaptive SCS

conventional SCS DEVICE

Conventional SCS can not change the parameter when the body position changes.

conventional SCS

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ,Parkinsonism(including idiopathic Parkinson's disease,Vascular Parkinson's disease, Atypical parkinsonism).
• , Aged 45-75 years old, Hoehn \& Yahr stage (medication off condition) at 2\~4;
• , Patients willingly seek surgical treatment for PD gait disturbance；
• , Walking disorder with freezing episodes, insufficiently alleviated by oral dopaminergic therapy and/or physiotherapy;
• , SCS eligibility has been confirmed by neurologist and neurosurgeon;
• , Ability to perform a gait/walking task (under close supervision);
• , Informed consent and have good compliance.

You may not qualify if:

• , Lesion in spinal cord or other surgical contraindications;
• , Other neuropsychiatric disorders or relevant medical history; haven't achieved the optimal therapeutic effects of DBS surgery or drug therapy;
• , Medical history of stroke, amyotrophic lateral sclerosis or myasthenia gravis; 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Gait Disorders, Neurologic; Parkinson Disease

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Dianyou Li, doctor

CONTACT

+8613817864569; ldy11483@rjh.com.cn

rui zhu

CONTACT

+8615026662357; zhurui_rjh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Stereotactic and Functional Neurosurgery, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: September 3, 2020
• Study Start: July 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)