Transcranial Direct Current Stimulation (tDCS) and Parkinson's Disease
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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | March 19, 2010 | ||||||||||||
| Last Updated Date | June 13, 2012 | ||||||||||||
| Start Date ICMJE | January 2010 | ||||||||||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Step Length [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ] Primary outcome variables from the gait parameters (GP) data will include step length. The patient will stand on the start line of the instrumented walkway. (GAITRite™) and walk having as much assistance from the investigator as needed until he/she traversed the entire length of the walkway. Data collection will begin automatically and rapidly processed with the system's software. Step length, gait velocity and cadence will be calculated. |
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| Change History | Complete list of historical versions of study NCT01100762 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Transcranial Direct Current Stimulation (tDCS) and Parkinson's Disease | ||||||||||||
| Official Title ICMJE | Can Transcranial Direct Current Stimulation (tDCS)Modulate Protective Stepping and Gait Performance of People With Parkinson's Disease | ||||||||||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Parkinson's Disease | ||||||||||||
| Intervention ICMJE |
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| Study Arm (s) | Experimental: Single Group
Interventions:
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 10 | ||||||||||||
| Completion Date | June 2011 | ||||||||||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years to 85 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01100762 | ||||||||||||
| Other Study ID Numbers ICMJE | HP-00040670 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Gad Alon, PT, PhD, University of Maryland | ||||||||||||
| Study Sponsor ICMJE | University of Maryland | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of Maryland | ||||||||||||
| Verification Date | June 2012 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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