Transcranial Direct Current Stimulation to Treat Symptoms of Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

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.

      ...
    

Detailed description: 
      The treatment of Parkinson's disease (PD) needs further improvement, particularly in the
      areas of gait and freezing. Transcranial direct current stimulation (tDCS) 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 tDCS 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 1-2 mA tDCS 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 tDCS effects over a period of
      four weeks (eight tDCS sessions, nine visits). Additional ratings will be done at one and
      three months after the end of tDCS 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.
    

Intervention name(s): Phoressor II (IOMED); Phoressor II (IOMED)
Intervention type(s): Device; Device
Intervention description(s): sham stimulation; real tDCS stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Human Brain; Electrical Stimulation; Parkinson Disease; PD