Transcranial Magnetic Stimulation to Treat Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will look at the effects of transcranial magnetic stimulation (TMS) on symptoms of
      Parkinson's disease. TMS is a method of brain stimulation that may be able to change the
      activity of the nerve cells of the brain. This study will examine the effects of a specific
      pattern of stimulation called intermittent theta-burst TMS (iTBS), which uses repeated
      magnetic pulses delivered in short bursts.

      People with mild to moderately severe Parkinson's disease who are between 40 and 80 years of
      age and whose main problems are slow movement and stiffness may be eligible for this study.

      Participants undergo the following tests and procedures:

        -  Random assignment to real or placebo (sham) iTBS treatment.

        -  iTBS sessions (real or sham) 4 times a week for 2 consecutive weeks. For this test, the
           subject sits in a comfortable chair. A wire coil is held on the subject's scalp, and a
           brief electrical current is passed through the coil, creating a magnetic pulse that
           stimulates the brain. The subject hears a click and may feel a pulling sensation on the
           skin under the coil. There may be a twitch in the muscles of the face, arm or leg.

        -  Test of gait (walk), hand and arm movements before and after each session. The gait test
           requires walking 10 meters (about 30 yards) in the same corridor with the same shoes.

        -  Extended testing. The first and last gait tests (done before starting iTBS and after the
           eighth session) require coming off any Parkinson's medication for at least 12 hours
           before the test. On these test days, subjects also undergo a clinical examination, short
           neuropsychological test battery, a computer-based reaction time test and depression and
           quality-of-life rating scales. These procedures are repeated in a follow-up visit 1
           month after the last session.
    

Detailed description: 
      Objective

      To demonstrate cumulative and long-lasting improvement of parkinsonian symptoms by iTBS and
      its safety in PD patients.

      Study population

      Patients (40-80 years of age) with PD, Hoehn and Yahr disease stage of 2 to 4 while off,
      being on a regimen including levodopa with a total dose of medication equal to more than 300
      mg of levodopa, including their dopamine agonist agents, and having problems with walking and
      needing 6 seconds or more to walk a 10-meter distance.

      Design

      Randomized, double-blind, placebo (sham)-controlled study. Enrollment of 30 patients with PD
      in 2 groups (real versus sham stimulation). Performance (8 interventions) of iTBS with large
      circular coil over motor and prefrontal cortex on both sides. Assessment with standard tests
      of motor function over a one-month period.

      Outcome measure

      The primary endpoint is change in gait speed as assessed by the time it takes to walk 10 m.

      Secondary endpoints include changes in bradykinesia as assessed by measuring the time it
      takes to do ten combined hand and arm movements, and in total and motor UPDRS score.
    

Intervention name(s): Real iTBS; Sham iTBS
Intervention type(s): Device; Device
Intervention description(s): Real iTBS was performed in 8 sessions over 2 successive weeks, a session/day for 4 consecutive days/week.; Sham iTBS was performed in 8 sessions over 2 successive weeks, a session/day for 4 consecutive days/week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Brain Stimulation; Motor Cortex; Bradykinesia; Parkinson Disease; PD