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

NCT01100762 | Completed Results DMC

• 1 other identifier: HP-00040670
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Cranial Electric Stimulation; Gait

Outcome Measures

Primary Outcomes (6)

• Stride Length

  Stride Length was measured in centimeters

  Data collection occurred before and immediately after each training session

• Gait Velocity

  Gait Velocity was measured in meters per second

  Data collection occurred before and immediately after each training session

• Cadence

  Cadence was measured in steps per minute

  Data collection occurred before and immediately after each training session

• 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

• 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

• First Step Velocity

  First step velocity was measured in meters per second

  Data collection occurred before and immediately after each training session

Study Arms (1)

Single Group

EXPERIMENTAL

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)

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

Interventions

Cranial Electric Stimulation (CES) DEVICE

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.

Single Group

Treadmill DEVICE

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

Single Group

CES and Treadmill DEVICE

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.

Single Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

PTRS Research Lab

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Limitations and Caveats

1. The absence of a placebo CES 2. Limiting the stimulation to only one region of interest (Right M1) 3. Non-random order of intervention 4. CES for only one 20 minute session

Results Point of Contact

• Title: Gad Alon, PhD, PT
• Organization: University of Maryland, Baltimore

galon@som.umaryland.edu

410-706-7733

Study Officials

• Gad Alon, PhD, PT

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

• Mark W Rogers, PhD, PT

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

• Lisa Shulman, MD

  Univeristy of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: April 9, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 30, 2019
• Results First Posted: May 7, 2012

Record last verified: 2019-10

Locations

US (1)