Transcutaneous Spinal Cord Stimulation for Parkinson Disease | NCT04171076

Studies
Transcutaneous Spinal Cord Stimulation for Parkinson Disease

NCT04171076

Sponsor

University of Sao Paulo General Hospital

Status

Unknown status

Last Update Posted

Nov 20, 2019Actual

Enrollment

5Estimated

Phase

Not Applicable

Conditions

Parkinson Disease
Gait, Rigid

Interventions

Transcutaneous spinal cord stimulation

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2019Actual

Primary Completion Date

Nov 15, 2019Estimated

Completion Date

Nov 30, 2019Estimated

First Submitted Date

Nov 10, 2019

First Submission Date that Met QC Criteria

Nov 18, 2019

First Posted Date

Nov 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2019

Last Update Posted Date

Nov 20, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rubens Gisbert Cury, Principal investigator, University of Sao Paulo General HospitalPrincipal Investigator

Lead Sponsor

University of Sao Paulo General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

Spinal cord stimulation has been used to treat gait problems in Parkinson's disease, with positive results along some studies. The use of non-invasive stimulation can be an alternative to stimulate the spinal corn. In this pilot trial, the investigators recruit participants with Parkinson' disease and freezing of gait. The aim of the study is to explore the safety along the non-invasive magnetic thoracic spinal cord stimulation as well the effect on gait problems, especially freezing of gait, prospectively, in an open-label fashion.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Intervention: non-invasive spinal cord stimulation	Procedure: Transcutaneous spinal cord stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcutaneous spinal cord stimulation	Procedure	Theta burst stimulation at thoracic level (T5) over 2 minutes	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Freezing of gait score	The primary outcome is the freezing of gait score. 12-item scale, each item scores 3 points at maximum; the score ranges from 0-36; higher scores mean higher severity	One week

Secondary Outcomes

Measure	Description	Time Frame
Gait speed	Gait speed measured through the time to up and go - It uses the time that a person takes to rise from a chair, walk ten meters, turn around, walk back to the chair, and sit down.	baseline, 1 week, 4 week
Freezing of gait questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of advanced idiopathic Parkinson's disease
significant freezing of gait despite optimized treatment with medications and rehabilitation program

Exclusion Criteria:

psychiatric symptoms
dementia
cardiac pacemaker

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

aged 18 years or higher

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of São Paulo	Recruiting	São Paulo	São Paulo	05403-000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D020233	Gait Disorders, Neurologic

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided