N/A
N=10
Transcranial Direct Current Stimulation (tDCS) and Parkinson's Disease
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01100762 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Stride Length — 102.10; 112.30; 109.80; 111.20 cm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cranial Electric Stimulation (CES) (Device); Treadmill (Device); CES and Treadmill (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stride Length |
102.10; 112.30; 109.80; 111.20; 110.40; 110.20 | — |
| PRIMARY Gait Velocity |
0.90; 102.10; 100.00; 0.985; 97.90; 98.30 | — |
| PRIMARY Cadence |
106.20; 109.30; 110.00; 107.00; 107.00; 107.20 | — |
| PRIMARY Number of Steps to Regain Balance |
2.22; 2.00; 2.28; 2.02; 2.10; 1.94 | — |
| PRIMARY First Step Length |
0.340; 0.333; 0.316; 0.317; 0.353; 0.326 | — |
| PRIMARY First Step Velocity |
0.859; 0.839; 0.767; 0.807; 0.873; 0.799 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01100762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.