Status:
COMPLETED
Transcranial Direct Current Stimulation to Treat Symptoms of Parkinson's Disease
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
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 stimulatio...
Detailed Description
The treatment of Parkinson's disease (PD) needs further improvement, particularly in the areas of gait and freezing. Transcranial direct current stimulation (tDCS) which passes weak direct current (DC...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients with PD corresponding to inclusion criteria will be recruited from the Human Motor Control Section Clinic (HMCS).
- Subjects will be men and women aged 40-80 years with DOPA-responsive, akinetic-rigid PD.
- Patients who have never participated in HMCS protocols for PD will be interviewed and examined by either the principal investigator or a physician from the Brain Stimulation Unit or HMCS in order to establish the diagnosis of PD and rule out any neurological condition. Only patients with a Hoehm and Yahr grade of 2 to 4 while "off" will be accepted.
- Patients must be on a regimen including levodopa. The total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 375 milligrams per day. Other anti-parkinsonian medications are also acceptable.
- Patients should have problems with walking, including freezing, so that their gait time for a 10-meter distance will be six seconds or more.
- EXCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00082342
Start Date
March 1 2003
Last Update
December 27 2012
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892