50 Hz Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Parkinson's Disease
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease, Transcranial Magnetic Stimulation (TMS), Treatment Study, PD, Parkinson Disease
Eligibility Criteria
- INCLUSION CRITERIA:
Men and women aged 40 to 80 years with DOPA-responsive PD
Hoehn and Yahr grade of 2 to 4 while off
Must be on a regimen including levodopa
Total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 300 milligrams per day
problems with walking and gait time for a 10-meter distance greater than six seconds or more
EXCLUSION CRITERIA:
Any active psychiatric disease
History of seizures and epilepsy
Concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than anti-parkinsonian agents that could lower the seizure threshold except for SSRI
Pallidotomy, implanted electrodes and generator for deep brain stimulation
Pregnancy
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.
Study would cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness.
Dementia as assessed by the Folstein's Mini-Mental Test Examination (MMSE less than or equal to 24/30) or mentally impaired patients having no capacity to provide their own consent (the physician establishing the diagnosis and applying UPDRS will evaluate patient's mental capacity using conventional clinical interview)
Unable to walk a 10-meter distance.
More than occasional falls, i.e. daily falls (corresponding to a score greater than or equal to 3 and more in UPDRS item 13), history of fall(s) with significant injuries, absence of postural response in the on and/or spontaneous loss of balance in the off condition (corresponding to a score of greater than or equal to 2 and greater than or equal to 3 in on/off condition, respectively, in UPDRS item 30)
Pregnancy is unusual in patients with PD, grade 2-4. Urine sample for the pregnancy test will be obtained in patients of childbearing potential prior to starting the 50 Hz rTMS and also at the initial interview after signing the consent form. Women of childbearing potential will be asked to take appropriate measures to prevent a pregnancy during the study.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Real rTMS
Sham rTMS