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

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ClinicalTrials.gov Identifier: NCT04408573
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Rubens Gisbert Cury, University of Sao Paulo General Hospital

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Cycling deep brain stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 2 weeks of regular continuous high frequency (>130Hz) stimulation, 2 weeks of cycling high frequency (>130Hz) stimulation (40sec on, 2sec off), 2 weeks of low-frequency (80Hz) continuous stimulation and 2 weeks of cycling low frequency (80Hz) stimulation (40sec on, 2sec off)
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Cycling Deep Brain Stimulation on Parkinson's Disease Gait
Actual Study Start Date : June 19, 2020
Estimated Primary Completion Date : May 29, 2021
Estimated Study Completion Date : December 29, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408573


Contacts
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Contact: Rubens G Cury, MD, PhD 55 11 26617877 rubens_cury@usp.br
Contact: Carina C França, MD 55 11 26617877 carina.fr@usp.br

Locations
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Brazil
Hospital das Clínicas da Faculdade de Medicina da USP Recruiting
São Paulo, SP, Brazil, 05403000
Contact: Rubens G Cury, MD PhD    55 11 26617877    rubens_cury@usp.br   
Sub-Investigator: Carina C França, MD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Rubens G Cury, MD, PhD University of Sao Paulo General Hospital
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Responsible Party: Rubens Gisbert Cury, Principal Investigator, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04408573    
Other Study ID Numbers: 67914017.6.0000.0068
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Time Frame: Data will be made available indefinitely upon reasonable request from other authors
Access Criteria: Investigator Rubens Cury will analyse request and decide upon reasonability

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases