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The use of low level electrical stimulation when applied over the head, also called transcranial direct current stimulation (tDCS), is being tested by several groups of researchers to see if tDCS can improve movements of persons with damage to the brain. The safety and potential benefits of tDCS to children or adults patients who are paralyzed because of brain damage are reported in the medical literature. In addition, some patients with Parkinson's disease (PD) experience improvement in memory and report better use of the hand after tDCS. The treatment requires putting electrodes (pads) over the head and sending very small amount of electrical current that the patient may feel as "little tingling". Application of tDCS takes 20 min. In this study we wish to test if tDCS application can improve stepping and walking ability of subjects with PD and if the improvement is the same as when walking on treadmill. We plan to test the subject's ability to step when pulled by a laboratory testing system and also test his/her walking ability. There will be 3 sessions 7 days apart. In the first session the subject will be tested then treated for 20 min with tDCS and then tested again. In the second session the subject will be tested then walk on a treadmill for 20 min then tested again. In the third session the subject will be tested then walk on the treadmill for 20 min while receiving also tDCS and tested one last time at the end of the session. Each session will take between 2 and 3 hours.
Recent advances in non-invasive electrical stimulation technology including transcranial direct current stimulation (tDCS) have provided novel and low risk options to rehabilitate the impaired ability of the central nervous system (CNS) to process sensorimotor information. Furthermore, tDCS appears to enhance CNS connectivity and there is preliminary evidence indicating that patients with Parkinson's Disease (PD) may experience improvement in working memory, the Unified Parkinson's Disease Rating Scale, simple reaction time and the Purdue Pegboard test. tDCS is inexpensive, portable and available for repeated home use. It may provide long-lasting enhancement of cortical activity in part because tDCS is easy to administer frequently and to combine it with other rehabilitation approaches including posture and gait training. However to date, no study has examined quantitatively the effects of tDCS on posture control and walking ability in patients with PD. As a first step we plan to identify the immediate effects of tDCS, as well as the added value of tDCS to treadmill exercise training, to improve posture and gait of individuals with PD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group | Experimental | 10 subjects with Parkinson's Disease receiving tPCS during the first session, treadmill walk, 7-10 days later (second session, and combined tPCS and treadmill 7-10 days week later (third session) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cranial Electric Stimulation (CES) | Device | We will follow the procedure described by several investigators as safe and effective. The participant will sit on a standard chair. Two commercially available surface electrodes will be embedded in an elastic head cup. Each electrode will be covered with a water soaked absorbent fabric. One positive (+) electrode will be placed over the primary motor cortex (M1) and pre-motor areas. One negative (-) electrode will be placed over the skin overlying the contra lateral supra-orbital region. The electrodes will be connected via 2 leads to a battery powered direct current stimulator. The stimulator will be programmed to deliver 0.975mA (peak 4mA) over 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Stride Length | Stride Length was measured in centimeters | Data collection occurred before and immediately after each training session |
| Gait Velocity | Gait Velocity was measured in meters per second | Data collection occurred before and immediately after each training session |
| Cadence | Cadence was measured in steps per minute | Data collection occurred before and immediately after each training session |
| Number of Steps to Regain Balance | Steps to regain balance were measured by the number of steps needed to recover standing balance. The steps were counted using a custom software of the motion capture system. | Data collection occurred before and immediately after each training session |
| First Step Length | First step length was measured in meters from the starting position of the foot to the maximum displacement of the foot after the first step. Measurements were taken separately for forward and backward first step. | Data collection occurred before and immediately after each training session |
| First Step Velocity | First step velocity was measured in meters per second | Data collection occurred before and immediately after each training session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gad Alon, PhD, PT | University of Maryland, Baltimore | Principal Investigator |
| Mark W Rogers, PhD, PT | University of Maryland, Baltimore | Principal Investigator |
| Lisa Shulman, MD | Univeristy of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PTRS Research Lab | Baltimore | Maryland | 21201 | United States |
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Study subjects were recruited via phone call or in person from the University of Maryland, Baltimore's Department of Neurology and the Department of Physical Therapy & Rehabilitation Sciences databases. The recruitment period was from January 2010 through June 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Group | In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes. In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes. In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Group | In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes. In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes. In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stride Length | Stride Length was measured in centimeters | Posted | Mean | Standard Deviation | cm | Data collection occurred before and immediately after each training session |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Group | In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes. In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes. In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gad Alon, PhD, PT | University of Maryland, Baltimore | 410-706-7733 | galon@som.umaryland.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Treadmill | Device | The participant will walk on a treadmill for 20 minutes at the individually self-selected velocity determined at baseline. |
|
| CES and Treadmill | Device | Participants will have a combined session with CES while walking on the treadmill for 20 minutes at the individually self-selected velocity determined at baseline. |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | CES and Treadmill | In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions. |
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| Primary | Gait Velocity | Gait Velocity was measured in meters per second | Posted | Mean | Standard Deviation | m/s | Data collection occurred before and immediately after each training session |
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| Primary | Cadence | Cadence was measured in steps per minute | Posted | Mean | Standard Deviation | steps/min | Data collection occurred before and immediately after each training session |
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| Primary | Number of Steps to Regain Balance | Steps to regain balance were measured by the number of steps needed to recover standing balance. The steps were counted using a custom software of the motion capture system. | Posted | Mean | Standard Deviation | steps | Data collection occurred before and immediately after each training session |
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| Primary | First Step Length | First step length was measured in meters from the starting position of the foot to the maximum displacement of the foot after the first step. Measurements were taken separately for forward and backward first step. | Posted | Mean | Standard Deviation | m | Data collection occurred before and immediately after each training session |
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| Primary | First Step Velocity | First step velocity was measured in meters per second | Posted | Mean | Standard Deviation | m/sec | Data collection occurred before and immediately after each training session |
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| 0 |
| 10 |
| 0 |
| 10 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |
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