Transcutaneous Spinal Cord Stimulation for Parkinson Disease

NCT ID: NCT04171076

Last Updated: 2019-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2019-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson Disease Gait, Rigid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Intervention: non-invasive spinal cord stimulation

Group Type EXPERIMENTAL

Transcutaneous spinal cord stimulation

Intervention Type PROCEDURE

Theta burst stimulation at thoracic level (T5) over 2 minutes

Interventions

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Transcutaneous spinal cord stimulation

Theta burst stimulation at thoracic level (T5) over 2 minutes

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rubens Gisbert Cury

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of São Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Rubens G Cury, MD

Role: primary

551126610000

Other Identifiers

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USaoPauloGH 1

Identifier Type: -

Identifier Source: org_study_id

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