CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Phoressor II (IOMED) +1 moredevice
Likely dose
Not stated in record
Key inclusion· 7
  • Age 40-80 years
  • DOPA-responsive, akinetic-rigid PD
  • Hoehn and Yahr grade 2-4 while 'off'
  • On levodopa-based regimen
Key exclusion· 6
  • Significant medical or psychiatric illness (except PD-related or levodopa-related symptoms)
  • Prior pallidotomy or DBS
  • Implanted pacemaker, medical pump, hearing aids, or metal in skull/eyes
  • Pregnancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00082342
NCT00082342Phase 2Completed

Transcranial Direct Current Stimulation for the Treatment of Parkinson's Disease

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted May 6, 2004·Updated Dec 27, 2012

In Brief

A Phase 2 clinical trial evaluating Phoressor II (IOMED) for Parkinson Disease. Completed, enrolled 25 participants across 1 site.

Detailed 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 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) tDCS. Both groups will have eight treatments over 3-1/2 weeks. For the tDCS, 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 tDCS session. Patients' motor function will be re-evaluated at 1, 3, and 6 months after the last tDCS treatment. ...

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 6, 2004
Enrollment StartMar 1, 2003
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 22.2 years ago

Interventions

Phoressor II (IOMED)device

sham stimulation

Phoressor II (IOMED)device

real tDCS stimulation