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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cranial Electric Stimulation (CES)
Treadmill
CES and Treadmill
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Cranial Electric Stimulation, Gait

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PTRS Research Lab

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Group

Arm Description

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)

Outcomes

Primary Outcome Measures

Stride Length
Stride Length was measured in centimeters
Gait Velocity
Gait Velocity was measured in meters per second
Cadence
Cadence was measured in steps per minute
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.
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.
First Step Velocity
First step velocity was measured in meters per second

Secondary Outcome Measures

Full Information

First Posted
March 19, 2010
Last Updated
October 28, 2019
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT01100762
Brief Title
Transcranial Direct Current Stimulation (tDCS) and Parkinson's Disease
Official Title
Can Transcranial Direct Current Stimulation (tDCS)Modulate Protective Stepping and Gait Performance of People With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, Cranial Electric Stimulation, Gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Group
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Cranial Electric Stimulation (CES)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Treadmill
Intervention Description
The participant will walk on a treadmill for 20 minutes at the individually self-selected velocity determined at baseline.
Intervention Type
Device
Intervention Name(s)
CES and Treadmill
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stride Length
Description
Stride Length was measured in centimeters
Time Frame
Data collection occurred before and immediately after each training session
Title
Gait Velocity
Description
Gait Velocity was measured in meters per second
Time Frame
Data collection occurred before and immediately after each training session
Title
Cadence
Description
Cadence was measured in steps per minute
Time Frame
Data collection occurred before and immediately after each training session
Title
Number of Steps to Regain Balance
Description
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.
Time Frame
Data collection occurred before and immediately after each training session
Title
First Step Length
Description
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.
Time Frame
Data collection occurred before and immediately after each training session
Title
First Step Velocity
Description
First step velocity was measured in meters per second
Time Frame
Data collection occurred before and immediately after each training session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gad Alon, PhD, PT
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark W Rogers, PhD, PT
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Shulman, MD
Organizational Affiliation
Univeristy of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
PTRS Research Lab
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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

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