- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04171076
Transcutaneous Spinal Cord Stimulation for Parkinson Disease
November 18, 2019 updated by: Rubens Gisbert Cury, University of Sao Paulo General Hospital
Transcutaneous Spinal Cord Stimulation for Freezing of Gait in Parkinson Disease
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sao Paulo
-
São Paulo, Sao Paulo, Brazil, 05403-000
- Recruiting
- University of São Paulo
-
Contact:
- Rubens G Cury, MD
- Phone Number: 551126610000
- Email: rubens_cury@usp.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Intervention: non-invasive spinal cord stimulation
|
Theta burst stimulation at thoracic level (T5) over 2 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freezing of gait score
Time Frame: One week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait speed
Time Frame: baseline, 1 week, 4 week
|
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
Time Frame: baseline, 1 week, 4 week
|
The freezing of gait questionnaire assess the freezing of gait severity in 9-item scale ( ranging from 0-28 points); higher score mean higher severity
|
baseline, 1 week, 4 week
|
Safety of the intervention - urinary incontinence
Time Frame: 1 week, 4 week
|
Incidence of Patients self report problems: urinary incontinence.
The urinary incontinence will be measure through the Revised Urinary Incontinence Scale, ranging from 0 to 16.
Higher scores mean higher the urinary symptoms.
|
1 week, 4 week
|
Safety of the intervention - lower limb strength.
Time Frame: 1 week, 4 week
|
Incidence of Patients self report problems: worsening in gait due to weakness.
The lower limb strength will be measure through the neurologic exam.
The force degree ranges from 0 - none, to 5 - normal strength.
|
1 week, 4 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2019
Primary Completion (Anticipated)
November 15, 2019
Study Completion (Anticipated)
November 30, 2019
Study Registration Dates
First Submitted
November 10, 2019
First Submitted That Met QC Criteria
November 18, 2019
First Posted (Actual)
November 20, 2019
Study Record Updates
Last Update Posted (Actual)
November 20, 2019
Last Update Submitted That Met QC Criteria
November 18, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- USaoPauloGH 1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on Transcutaneous spinal cord stimulation
-
James J. Peters Veterans Affairs Medical CenterRecruitingOrthostatic HypotensionUnited States
-
University of British ColumbiaProvidence Health & Services; International Spinal Research Trust; International...RecruitingSexual Dysfunction, Physiological | Spinal Cord Injuries | Neurogenic Bowel | Neurogenic Bladder | Spinal Cord StimulationCanada
-
University of Mississippi Medical CenterMethodist Rehabilitation CenterRecruitingSpinal Cord Injuries | Spasticity, MuscleUnited States
-
University of British ColumbiaPraxis Spinal Cord InstituteRecruitingSpinal Cord Injuries | Neurogenic Bowel | Neurogenic BladderCanada
-
Medical University of ViennaNeurological Center, Otto Wagner HospitalCompleted
-
University of PittsburghMedical University of South Carolina; Eunice Kennedy Shriver National Institute... and other collaboratorsTerminatedAmputation | Phantom Limb Pain | Hoffman's ReflexUnited States
-
Peter LacknerMedical University of ViennaCompletedSpinal Cord InjuriesAustria
-
University of LouisvilleRecruiting
-
Mayo ClinicMinnesota Office of Higher EducationTerminatedParaplegia, Spinal | Paraplegia, Complete | Paraplegia; TraumaticUnited States
-
The Methodist Hospital Research InstituteNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingSpinal Cord Injuries | NeuromodulationUnited States