Cycling Deep Brain Stimulation on Parkinson's Disease Gait (DBS)

June 19, 2020 updated by: Rubens Gisbert Cury, University of Sao Paulo General Hospital

Effects of Cycling Deep Brain Stimulation on Parkinson's Disease Gait

Our hypothesis is that cycling DBS stimulation would be superior or non-inferior to regular DBS stimulation in Parkinson's disease patients with gait impairment. The objective of this study is compare gait disorders in patients with Parkinson's disease and DBS in 4 different scenarios: 1) regular continuous high frequency (>130Hz) stimulation, 2) cycling high frequency (>130Hz) stimulation (40sec on, 2sec off), 3) low-frequency (80Hz) continuous stimulation and 4) cycling low frequency (80Hz) stimulation (40sec on, 2sec off)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gait disorders such as falls, freezing of gait, reduction of speed, shuffling, and multi-stepped turning are common in patients with moderate and advanced Parkinson's disease. Compared to appendicular symptoms (bradykinesia, tremor, and rigidity), gait disorders tend to be more resistant to medical and regular deep brain stimulation treatment, and greatly impairs patients' quality of life and daily living activities. Some stimulation strategies have been tried to improve gait in Parkinson's disease patients, but so far most of them resulted in concomitant worsening of appendicular symptoms. However, new stimulation strategies such as cycling stimulation can potentially improve gait disorders without impairment of appendicular symptoms.

Study Type

Interventional

Enrollment (Anticipated)

30

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

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403000
        • Recruiting
        • Hospital das Clinicas da Faculdade de Medicina da USP
        • Contact:
        • Sub-Investigator:
          • Carina C França, MD

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 idiopathic Parkinson's disease
  • Currently receiving Deep Brain Stimulation as a Parkinson's disease treatment
  • Hoehn & Yahr stage between 2-4 during off-medication
  • Underlying gait disorders despite optimal medical and stimulation treatment: score over or equal to 1 in the subitem 2.12 of the MDS-UPDRS scale
  • Willingness to comply with all study procedures

Exclusion Criteria:

  • Active moderate/severe psychiatric condition
  • Active infection or other uncontrolled moderate/grave comorbidities
  • Treatment with experimental drug
  • Pregnancy or breast-feeding

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Regular Continuous High Frequency
Patient remains 2 weeks in the currently chosen stimulation protocol.
Experimental: Cycling High Frequency
Patient is stimulated with the same polarity, voltage/current, pulse width and frequency as the currently chosen stimulation protocol, but with cycling stimulation: 40sec On - 02 sec OFF
Other: Cycling deep brain stimulation
Deep Brain Stimulation applied in cycling - periods of stimulation ON intercalated with periods of stimulation OFF
Experimental: Continuous Low Frequency
Patient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz). Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol.
Other: Cycling deep brain stimulation
Deep Brain Stimulation applied in cycling - periods of stimulation ON intercalated with periods of stimulation OFF
Experimental: Cycling Low Frequency
Patient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz) and cycling stimulation: 40sec On - 02 sec OFF. Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol.
Other: Cycling deep brain stimulation
Deep Brain Stimulation applied in cycling - periods of stimulation ON intercalated with periods of stimulation OFF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the part II of the Unified Parkinson's disease rating scale
Time Frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
The part II of the Unified Parkinson's disease rating scale (UPDRS II) is a self-reportable questionnaire consisting of 13 items that measure functionality (motor experiences of daily living). Scores vary from 0 - 52. Higher scores mean a worse outcome.
Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Change in the New Freezing of Gait Questionnaire
Time Frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
The New Freezing of Gait Questionnaire (NFOG-Q) is a self-reportable questionnaire consisting of 9 items that measure freezing of gait (FOG). Scores vary from 0 - 28. Higher scores mean a worse outcome.
Baseline + after 2 weeks + after 4 weeks + after 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Falls Efficacy Scale
Time Frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
The Falls Efficacy Scale (FES) is a sixteen-item test rated on a 10-point scale from not confident at all to completely confident. It is correlated with difficulty getting up from a fall and level of anxiety. Scores vary from 16 - 64. Higher scores mean a worse outcome.
Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Change in The Parkinson's Disease Questionnaire (PDQ-39)
Time Frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
This questionnaire assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living. The 39 item questionnaire offers a patient reported measure of health status and quality of life and is the most frequently used disease-specific health status measure.Scores vary from 0 - 156. Higher scores mean a worse outcome.
Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Change in Activities-Specific Balance Confidence Scale (ABC scale)
Time Frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
The ABC scale is a self-report measure of balance in performing various activities without losing balance or experiencing a sense of unsteadiness. Scores vary from 0 - 100. Higher scores mean a better outcome.
Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Number of falls
Time Frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Patients will be questioned about number of times they experienced falls in the last 2 weeks. Higher numbers mean a worse outcome.
Baseline + after 2 weeks + after 4 weeks + after 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Rubens G Cury, MD, PhD, University of Sao Paulo General Hospital

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)

June 19, 2020

Primary Completion (Anticipated)

May 29, 2021

Study Completion (Anticipated)

December 29, 2021

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

May 25, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 67914017.6.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

Data will be made available indefinitely upon reasonable request from other authors

IPD Sharing Access Criteria

Investigator Rubens Cury will analyse request and decide upon reasonability

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.

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