Transcranial Direct Current Stimulation to Treat Symptoms of Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Phoressor II (IOMED); Phoressor II (IOMED)
Intervention description: sham stimulation; real tDCS stimulation
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Human Brain; Electrical Stimulation; Parkinson Disease; PD

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.

      ...
    

Eligibility 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 2 to 4 while "off" will be
        accepted.

        Patients must be on a regimen including levodopa. The total dose of levodopa and dopamine
        agonists (using dopamine equivalents) has to be equal to or more than 375 milligrams per
        day. Other anti-parkinsonian medications are also acceptable.

        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:

        Exclusion criteria are any significant medical or psychiatric illnesses (except those
        symptoms often associated with PD or levodopa therapy, such as sundowning and benign
        hallucination), pallidotomy, implanted electrodes and generator for deep brain stimulation,
        pregnancy.

        Persons with surgically 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. 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
        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.