Transcranial Direct Current Stimulation (tDCS) and Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gad Alon, PT, PhD, University of Maryland
ClinicalTrials.gov Identifier:
NCT01100762
First received: March 19, 2010
Last updated: June 13, 2012
Last verified: June 2012

March 19, 2010
June 13, 2012
January 2010
June 2011   (final data collection date for primary outcome measure)
  • Stride Length [ Time Frame: Data collection occurred before and immediately after each training session ] [ Designated as safety issue: No ]
    Stride Length was measured in centimeters
  • Gait Velocity [ Time Frame: Data collection occurred before and immediately after each training session ] [ Designated as safety issue: No ]
    Gait Velocity was measured in meters per second
  • Cadence [ Time Frame: Data collection occurred before and immediately after each training session ] [ Designated as safety issue: No ]
    Cadence was measured in steps per minute
  • Number of Steps to Regain Balance [ Time Frame: Data collection occurred before and immediately after each training session ] [ Designated as safety issue: No ]
    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.
  • First Step Length [ Time Frame: Data collection occurred before and immediately after each training session ] [ Designated as safety issue: No ]
    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.
  • First Step Velocity [ Time Frame: Data collection occurred before and immediately after each training session ] [ Designated as safety issue: No ]
    First step velocity was measured in meters per second
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.
Complete list of historical versions of study NCT01100762 on ClinicalTrials.gov Archive Site
Not Provided
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Transcranial Direct Current Stimulation (tDCS) and Parkinson's Disease
Can Transcranial Direct Current Stimulation (tDCS)Modulate Protective Stepping and Gait Performance of People With Parkinson's Disease

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
  • Device: Cranial Electric Stimulation (CES)
    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.
  • Device: Treadmill
    The participant will walk on a treadmill for 20 minutes at the individually self-selected velocity determined at baseline.
  • Device: CES and Treadmill
    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.
Experimental: Single Group
Interventions:
  • Device: Cranial Electric Stimulation (CES)
  • Device: Treadmill
  • Device: CES and Treadmill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of adult onset of PD
  • A history of freezing of gait (FOG) as evidence by clinical assessment
  • A stable regimen of anti-parkinsonian medications
  • Ability to walk at least 10m without assistance
  • Ability to walk on a treadmill for 20 minutes
  • Personal weight of less than 500 Lb (because the suspension harness over the treadmill is limited to 500 Lb
  • Stage 3 of the Hoehn and Yahr disability scale
  • A score of >24 on the Mini Mental State Examination

Exclusion Criteria:

  • Evidence of any clinically significant functional impairment related to cardiovascular, pulmonary, metabolic, other neurologic or musculoskeletal disease criterial that would preclude participation in training
  • Any medical condition that might require other medical or surgical treatment during the study period
  • A history of brain surgery or placement of a deep brain stimulator
  • Dyskinesias > grade 2 on the Unified Parkinson's Disease Rating Scale (UPDRS)
  • Any uncorrected vision or hearing problems that may limit daily activities or communication
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01100762
HP-00040670
Yes
Gad Alon, PT, PhD, University of Maryland
University of Maryland
Not Provided
Principal Investigator: Gad Alon, PhD, PT University of Maryland, Baltimore County
Principal Investigator: Mark W Rogers, PhD, PT University of Maryland, Baltimore County
Principal Investigator: Lisa Shulman, MD Univeristy of Maryland, Baltimore
University of Maryland
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP