rTMS for Motor and Mood Symptoms of Parkinson's Disease
Condition: Parkinson's Disease; Depression
MeSH terms: Parkinson Disease; Depression
Study type: Interventional

Summary: 
      The purpose of this study is to determine if repetitive transcranial magnetic stimulation
      (rTMS), a method of noninvasive brain stimulation) is effective in the treatment of the motor
      (movement) and mood symptoms due to Parkinson's disease (PD).
    

Detailed description: 
      Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive means of brain
      stimulation which can produce changes to brain excitability. Following a series of daily rTMS
      sessions, this modulation of neural circuits and other distant effects may help some of the
      motor and neuropsychiatric symptoms of PD for months at a time. Recently, the FDA approved
      daily rTMS over the prefrontal cortex as a treatment for medication-refractory depression
      after demonstration of efficacy in sham-controlled trials and its safety profile. Among
      several small and pilot studies of rTMS in PD patients, rTMS over either the motor cortex or
      prefrontal cortex has been reported to show beneficial effects on motor and mood (depression)
      symptoms with no serious adverse events. However, the relative effectiveness of rTMS over
      motor, prefrontal, or both regions on both mood and motor symptoms, has yet to be established
      in PD patients.

      We propose to conduct a four-center, blinded, sham-controlled, randomized, parallel-group
      study of fixed-dose, high-frequency rTMS in 160 PD patients who are experiencing depressive
      symptoms despite an adequate trial of at least one antidepressant. Subjects will be
      randomized to receive rTMS over either motor cortex, prefrontal cortex, both, or neither
      (sham-rTMS). Subjects will receive rTMS for 25 minutes over either the prefrontal cortex (the
      brain region associated with mood and depression), and/or primary motor cortex (associated
      with motor control), and/or sham-rTMS. After 10 days of rTMS (or sham) treatment over a
      2-week period, all subjects will undergo a comprehensive assessment of motor, mood, cognition
      and quality of life on the first working day after the last rTMS treatment, and after 1, 3
      and 6 months post-treatment. This study directly addresses the expansion of rTMS as an
      alternative treatment for depression in the PD population and will provide evidence as to
      whether motor cortex stimulation will provide additional and/or separate benefit to motor
      symptoms.
    

Intervention name(s): Repetitive transcranial magnetic stimulation (rTMS)
Intervention type(s): Device
Intervention description(s): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS.
Other intervention name(s): Transcranial Magnetic Stimulation; Noninvasive Brain Stimulation; Magstim Corporation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Depression; Transcranial Magnetic Stimulation