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

Parkinson's Disease Clinical Trial

Official title:

Can Transcranial Direct Current Stimulation (tDCS)Modulate Protective Stepping and Gait Performance of People With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100762
• Other study ID #: HP-00040670
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: October 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.
• Treadmill
The participant will walk on a treadmill for 20 minutes at the individually self-selected velocity determined at baseline.
• 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.

Locations

Country	Name	City	State
United States	PTRS Research Lab	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stride Length	Stride Length was measured in centimeters	Data collection occurred before and immediately after each training session
Primary	Gait Velocity	Gait Velocity was measured in meters per second	Data collection occurred before and immediately after each training session
Primary	Cadence	Cadence was measured in steps per minute	Data collection occurred before and immediately after each training session
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.	Data collection occurred before and immediately after each training session
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.	Data collection occurred before and immediately after each training session
Primary	First Step Velocity	First step velocity was measured in meters per second	Data collection occurred before and immediately after each training session