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

Not Applicable

Completed

Conditions: Parkinson's Disease

Interventions: Device: Cranial Electric Stimulation (CES)
Device: Treadmill
Device: CES and Treadmill

Registration Number: NCT01100762

Lead Sponsor: University of Maryland, Baltimore

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Group	Cranial Electric Stimulation (CES)	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)
Single Group	Treadmill	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)
Single Group	CES and Treadmill	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)

Primary Outcome Measures

Name	Time	Method
Cadence	Data collection occurred before and immediately after each training session	Cadence was measured in steps per minute
Gait Velocity	Data collection occurred before and immediately after each training session	Gait Velocity was measured in meters per second
Stride Length	Data collection occurred before and immediately after each training session	Stride Length was measured in centimeters
First Step Velocity	Data collection occurred before and immediately after each training session	First step velocity was measured in meters per second
Number of Steps to Regain Balance	Data collection occurred before and immediately after each training session	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	Data collection occurred before and immediately after each training session	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.