Parkinson's Disease
Conditions
Keywords
Deep Brain Stimulation
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.
Interventions
DEVICEDeep Brain Stimulator
DBS will provide brain stimulation.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with idiopathic Parkinson's disease stage 1-3 that underwent subthalamic nucleus (STN) Deep Brain Stimulation (DBS) and have walking difficulties 6-12 months after DBS. * On stable dose of dopaminergic drugs * Age 45-70 years of age
Exclusion criteria
* Past medical history of seizures * Renal insufficiency * Cardiac arrhythmia * Severe arthritis * Women of childbearing potential * Dementia * Less than 45 years of age or older than 70 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Speed | Up to 1 hour | Walking speed will be measured using sensors reported in meter per second. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stride Length | Up to 1 hour | Stride length will be measured using sensors and will be reported in meters. |
| UPDRS Scores | Up to 1 hour | Unified Parkinson's disease rating Scale (UPDRS) has a total score ranging from 0-108 with the highest score indicating worse condition. |
| TUG Test | Up to 1 hour | Time Up and Go (TUG) Test reports the time it takes for participant to stand up from chair, walk around a cone and return to chair. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants that completed the 4 arm crossover study design | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
Walking Speed
Walking speed will be measured using sensors reported in meter per second.
Time frame: Up to 1 hour
Population: All participants completed all 4 arms in the cross over study design.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Stimulation | Walking Speed | 0.95 meter per second | Standard Deviation 0.05 |
| Left Stimulation | Walking Speed | 0.90 meter per second | Standard Deviation 0.05 |
| Right Stimulation | Walking Speed | 0.92 meter per second | Standard Deviation 0.05 |
| OFF Stimulation | Walking Speed | 0.84 meter per second | Standard Deviation 0.07 |
Secondary
Stride Length
Stride length will be measured using sensors and will be reported in meters.
Time frame: Up to 1 hour
Population: all participants completed all 4 arms in the crossover study design.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Stimulation | Stride Length | 1.09 meters | Standard Deviation 0.04 |
| Left Stimulation | Stride Length | 1.01 meters | Standard Deviation 0.05 |
| Right Stimulation | Stride Length | 1.06 meters | Standard Deviation 0.04 |
| OFF Stimulation | Stride Length | 0.95 meters | Standard Deviation 0.06 |
Secondary
TUG Test
Time Up and Go (TUG) Test reports the time it takes for participant to stand up from chair, walk around a cone and return to chair.
Time frame: Up to 1 hour
Population: Team member with access to TUG score data analysis has left the institution. PI was not given access to retrieve data prior to study team member leaving the institution.
Secondary
UPDRS Scores
Unified Parkinson's disease rating Scale (UPDRS) has a total score ranging from 0-108 with the highest score indicating worse condition.
Time frame: Up to 1 hour
Population: All participants completed all 4 arms in the crossover study design
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Stimulation | UPDRS Scores | 24.09 score on a scale | Standard Deviation 2.76 |
| Left Stimulation | UPDRS Scores | 38.36 score on a scale | Standard Deviation 3.52 |
| Right Stimulation | UPDRS Scores | 35.59 score on a scale | Standard Deviation 3.19 |
| OFF Stimulation | UPDRS Scores | 48.68 score on a scale | Standard Deviation 3.41 |