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Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02022735
Recruitment Status : Active, not recruiting
First Posted : December 30, 2013
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Corneliu C Luca, University of Miami

Brief Summary:
The purpose of this study is to evaluate the effect of Deep Brain stimulation (DBS) on walking in patients with Parkinson's disease that have had DBS. While DBS improves Parkinson's disease (PD) symptoms and walking in many patients in some of the patients walking problems persist. This study aims to find out what are the best stimulation parameters of the DBS in order to improve walking.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Deep Brain Stimulation Not Applicable

Detailed Description:

Parkinson disease (PD) is defined by the presence of a resting tremor, slowness, stiffness and problems with balance and walking. Gait disorder in Parkinson's disease is common and has a greater impact on quality of life. Currently, carbidopa-levodopa and Deep Brain Stimulation are the only treatments available for gait impairment.

This study is meant to see if there is improvement in gait or freezing of gait are seen after changes in the stimulation parameters. Subjects will be randomly assigned to four different stimulation parameters: both stimulators on (BL ON), both stimulators off (BL OFF), right stimulator on (R ON), left stimulator on (L ON). The investigators will assess your gait using a clinical scales as well as wearable sensors attached to your body. Assessments will be done one hour after each change in the stimulation parameters.

Gait will be studied using wireless sensors attached to the ankles and wrists to determine speed, stride length and turning time.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease.
Study Start Date : September 2013
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bilateral stimulation
Deep Brain Stimulation Bilaterally
Device: Deep Brain Stimulation
Other Name: DBS

Experimental: Left stimulation
Deep Brain Stimulation Left side only
Device: Deep Brain Stimulation
Other Name: DBS

Experimental: Right stimulation
Deep Brain Stimulation Right side only
Device: Deep Brain Stimulation
Other Name: DBS

No Intervention: OFF stimulation
No stimulation



Primary Outcome Measures :
  1. velocity and stride length [ Time Frame: velocity and stride length will be measured one hour after each change in stimulation. ]
    changes in velocity. stride length will be measured after each change in stimulation parameters. Changes will be performed every one hour at baseline, time 1h, 2h and 3h.


Secondary Outcome Measures :
  1. United Parkinson Disease Rating Scale- part 3 [ Time Frame: one hour after each change in stimulation ]
    changes in UPDRS will be measured after each change in stimulation parameters. Changes will be performed every one hour at baseline, time 1h, 2h and 3h.

  2. stride time variability [ Time Frame: one hour after each change in stimulation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parkinson's disease stage 1-3
  • walking impairment

    •Exclusion Criteria:

  • stage 4,5
  • dementia

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): NCT02022735


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Corneliu Luca, MD, PhD University of Miami

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Responsible Party: Corneliu C Luca, Assistant Professor of Neurology, University of Miami
ClinicalTrials.gov Identifier: NCT02022735     History of Changes
Other Study ID Numbers: 20130225
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019

Keywords provided by Corneliu C Luca, University of Miami:
Deep Brain Stimulation

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