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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01100762

Enrollment

Registered

2010-04-09

Start date

2010-01-31

Completion date

2011-06-30

Last updated

2019-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease, Cranial Electric Stimulation, Gait

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.

Interventions

DEVICECranial 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.

DEVICETreadmill

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

DEVICECES 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

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

Countries

United States

Participant flow

Recruitment details

Study subjects were recruited via phone call or in person from the University of Maryland, Baltimore's Department of Neurology and the Department of Physical Therapy & Rehabilitation Sciences databases. The recruitment period was from January 2010 through June 2011.

Participants by arm

Arm	Count
Single Group In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes. In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes. In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.	10
Total	10

Arm

Count

Single Group

In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes. In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes. In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.

Total

Baseline characteristics

Characteristic	Single Group
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	9 Participants
Age, Categorical Between 18 and 65 years	1 Participants
Sex: Female, Male Female	3 Participants
Sex: Female, Male Male	7 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 10
serious Total, serious adverse events	0 / 10