50 Hz Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Background:

        -  In transcranial magnetic stimulation (TMS), a device creates a short-lasting magnetic
           field which induces an electric current in the brain leading to a change in the activity
           of brain cells. There are different effects on the brain with different rates of
           stimulation. In a previous study in people with Parkinson's disease, repetitive TMS
           (rTMS) given at a particular rate temporarily improved their ability to walk. A faster
           rate of rTMS may be more effective in treating symptoms than the rate originally used.

        -  This study will compare active rTMS to inactive (sham or Placebo) rTMS. Half of the
           people in this study will have active rTMS; the other half will have no brain
           stimulation with rTMS.

      Objectives:

      - To see if a faster rate of transcranial magnetic stimulation is a more effective treatment
      for the symptoms of Parkinson's disease than the slower rates that have been studied.

      Eligibility:

        -  Individuals between 40 and 80 years of age who have been diagnosed with mild or moderate
           Parkinson's disease.

        -  Participants must currently be taking Sinemet or dopamine agonists drugs (e.g.,
           bromocriptine, cabergoline, pergolide, pramipexole, ropinirole, apomorophine, and
           rotigotine), and are willing to continue their same treatments for the duration of the
           study.

      Design:

        -  This study requires 11 outpatient visits to the NIH Clinical Center over 6 weeks.
           Participants can also be admitted and stay as an inpatient in the NIH Clinical Center
           for the entire study period (for the 10 visits during the first weeks and the follow-up
           visit a month later).

        -  Initial visit will consist of a physical examination; a test of participants' time to
           walk 10 meters; and questions about memory, mood, and quality of life. Participants
           should not take Parkinson's disease medications for 12 hours before this visit; once the
           examinations and tests are complete, participants will be able to take the medications.
           Researchers will repeat the tests 1 hour after participants take the medication.

        -  TMS sessions: 8 TMS sessions (4 sessions per week) over 2 weeks. Each stimulation
           session will last half an hour. Half of the participants will receive active TMS; the
           other half will receive sham TMS.

        -  The first 10 participants will have additional tests to study the safety of rapid TMS in
           patients with Parkinson's disease.

        -  A day after completing the last TMS session, participants will repeat the same tests as
           the first visit before and after taking their medication as in the first assessment and
           respond to questions about mood, memory, and quality of life.

        -  One month after completing the last TMS session, participants will repeat the same tests
           as the first visit before and after taking their medication.
    

Detailed description: 
      Objective:

      To demonstrate cumulative and long-lasting improvement of parkinsonian symptoms by 50 Hz rTMS
      (repetitive transcranial magnetic stimulation) and its safety in Parkinson's Disease (PD)
      patients.

      Study population:

      Up to 30 PD patients in Hoehn and Yahr disease stage 2-4 while off medication will be
      enrolled. Patients must be receiving more than 300 mg of levodopa (including dopamine
      agonists) and have gait problems.

      Design:

      This is a randomized, double-blind, placebo (sham)-controlled study of 26 patients with PD in
      2 groups (real versus sham stimulation). The study involves performance (8 interventions) of
      50 Hz rTMS with large circular coil over the motor cortex on both sides of the brain.
      Assessment of PD symptoms with standard tests of motor function will be performed over a
      one-month period.

      Outcome measure:

      The primary endpoint include the changes in gait speed as assessed by the time it takes to
      walk 10 meters and the changes in bradykinesia as assessed by measuring the time it takes to
      do 10 combined hand and arm movements.

      Secondary endpoints include the changes in the total, motor and activities of daily living
      Unified Parkinson's Disease Rating Scale (UPDRS) score.
    

Intervention name(s): 50 HZ Repetitive TMS; Sham rTMS
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Transcranial Magnetic Stimulation (TMS); Treatment Study; PD; Parkinson Disease