Transcranial Direct Current Stimulation to Treat Symptoms of Parkinson's Disease
Completed · Phase 2 · Has a placebo group
Conditions studied: Parkinson Disease
In brief
This study will examine the effects of transcranial direct current stimulation (tDCS) on gait (walking) problems and rigidity in patients with Parkinson's disease. tDCS is a method of brain stimulation that may be able to change the electrical activity of the nerves of the brain, possibly causing Parkinson's disease symptoms to improve. Patients between 40 and 80 years of age with moderately severe Parkinson's disease whose main symptoms are problems with walking, including freezing, or rigidity, may be eligible for this study. Candidates must be taking Sinemet or another L-DOPA drug and not have too much tremor. Participants will be assigned to receive either real or sham (placebo) tDCS. Both groups will have eight treatments over 3-1/2 weeks. For the tDCS, electrodes are placed on wet pads on the scalp. An electrical current passes through the electrodes, travels through the scalp and skull, and causes small electrical currents in the cortex-the outer part of the brain. Participants will have a neurological examination, including an evaluation of walking, just before and just after each tDCS session. Patients' motor function will be re-evaluated at 1, 3, and 6 months after the last tDCS treatment. ...
Key facts
- Study ID
- NCT00082342
- Run by
- National Institute of Neurological Disorders and Stroke (NINDS)
- People needed
- 25
- Starts
- 2003-03-01
- Last updated by the study team
- 2012-12-27
Who can join
Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Exclusion criteria are any significant medical or psychiatric illnesses (except those symptoms often associated with PD or levodopa therapy, such as sundowning and benign hallucination), pallidotomy, implanted electrodes and generator for deep brain stimulation, pregnancy.
- Persons with surgically or traumatically implanted foreign bodies such as a pacemaker, implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during TEP will also be excluded. Most of these exclusions also come under the category of significant medical illness.
- Patients for whom participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness will also be excluded.
- Patients unable to walk a 10-meter distance will be excluded.
- Mentally impaired patients having no capacity to provide their own consent will be excluded from the study.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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