This study will examine the effects of transcranial electrical polarization (TEP) on gait (walking) problems and rigidity in patients with Parkinson's disease. TEP 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) TEP. Both groups will have eight treatments over 3-1/2 weeks. For the TEP, 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 TEP session. Patients' motor function will be re-evaluated at 1, 3, and 6 months after the last TEP treatment.

Condition	Treatment or Intervention	Phase
Parkinson Disease	Drug: Phoressor II (IOMED)	Phase II

Further Study Details: 

Expected Total Enrollment:  46

The treatment of Parkinson's disease (PD) needs further improvement, particularly in the area of gait and freezing. Transcranial electrical polarization (TEP) which passes weak DC current through the skull and across the cortex has been done for many years with numerous effects described in healthy subjects and patients with mental illness. Recently, it has been shown by objective means, in controlled experiments, that this type of treatment has robust and lasting effects on the excitability of the motor cortex in healthy humans. We hypothesize that TEP will have a beneficial effect on gait and freezing in medicated patients, and we propose to test this in a controlled trial. Specifically, we propose to look at the effect of 1-2mA TEP with anode position over the frontal poles and/or premotor and primary motor cortex, and cathode over mastoid process. Over a one-year period, we will enroll 40 adults with PD and evaluate the acute TEP effects over a period of four weeks (eight TEP sessions, nine visits). Additional ratings will be done at one, three, and six months after the end of TEP sessions. Symptoms will be evaluated with standard tests of motor function, including the UPDRS and specific tests of gait and freezing. We will also look for cumulative, long-lasting effects over the six-month period.

Genders Eligible for Study:  Both

Criteria

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 3 to 4 while "off" will be accepted.
Patients must be on a regimen including levodopa and have a total dose of levodopa equal to or more than 375 milligrams per day; they also can be taking other anti-parkinsonian medications including direct dopamine agonists.
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:
Any significant medical or psychiatric illness (other than PD), pallidotomy, implanted electrodes and generator for deep brain stimulation, pregnancy, history of epilepsy, 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 surgical 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.
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.

Maryland
      National Institute of Neurological Disorders and Stroke (NINDS), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  030116; 03-N-0116
Record last reviewed:  November 23, 2004
Last Updated:  January 5, 2005
Record first received:  May 6, 2004
ClinicalTrials.gov Identifier:  NCT00082342
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08