symptoms of parkinsons disease : Clincal trial

Purpose

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.

Study Type: Interventional
Study Design: Treatment

Official Title: Transcranial Electrical Polarization for the Treatment of Bradykinesia and Rigidity in Patients With Parkinson's Disease.

Further study details as provided by National Institutes of Health Clinical Center (CC):
Primary Outcomes: Meaurement of the freezing and balance/gait, bradykinesia, and rigidity immediately before and after each TEP session, to estimate the therapeutic effect over the course of treatment.
Secondary Outcomes: Measure long-lasting therapeutuc TEP effects.
Expected Total Enrollment: 46
Study start: March 2003
Last follow-up: April 2006; Data entry closure: April 2006

The treatment of Parkinson's disease (PD) needs further improvement, particularly in the areas of gait and freezing. Transcranial electrical polarization (TEP) which passes weak direct current (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 42 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 and three months after the end of TEP sessions. Symptoms will be evaluated with standard tests of motor function, including the Unified Parkinson's Disease Rating Scale (UPDRS) and specific tests of gait and freezing. We will also look for cumulative, long-lasting effects over the three-month period.

http://www.clinicaltrials.gov/ct/show/NCT00082342