Investigating the Safety of srTMS in the Treatment of Parkinson's Disease
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Electrical Stimulation, Human Brain, Parkinson Disease, PD
Eligibility Criteria
INCLUSION CRITERIA: Subjects will be men and women aged 40 to 80 years with DOPA-responsive, akinetic-rigid PD. After obtaining the informed consent, patients will be interviewed and examined by either the prinicipal investigator (PI) or a Brain Stimulation Unit (BSU) or an HMCS physician to establish the diagnosis of PD and rule out any other neurologic condition. Only patients with a Hoehn and Yahr grade of 2 to 4 while 'off' will be accepted. Patients must be on a regimen including L-DOPA, and they must have a total dose of medication equal to more than 300 mg of L-DOPA equivalent, including their dopamine agonist agents. Any patient whose record does not contain a neurological examination from the past year will be reexamined before enrollment. EXCLUSION CRITERIA: Any significant medical or psychiatric illness (other than PD), pregnancy, history of epilepsy, or concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than antiparkinsonian agents that could lower the seizure threshold. Persons with surgically or traumatically implanted foreign bodies such as a pacemaker, or any implanted stimulators, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during magnetic stimulation 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 fatigue, general frailty, or excessive apprehensiveness will also be excluded. A urine sample for the pregnancy test will be obtained from any women of childbearing potential prior to the start of srTMS, on the day of the initial interview and signing of the consent form. Pregnant women will be excluded from the study. Mentally impaired patients who have no capacity to provide their own consent will be excluded from the study.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike