Investigating the Safety of srTMS in the Treatment of Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Super rapid transcranial magnetic stimulation (srTMS) is a method of brain stimulation that
      may be able to change the electrical activity of the nerve cells of the brain. It has been
      proposed and tested as a treatment for brain disorders, including Parkinson's disease.

      The purpose of this study is to use a device called the magnetic stimulator to investigate
      the safe limit of srTMS, such as intensity of stimulation and the number of magnetic pulses
      that may lead to excessive brain stimulation.

      Ten patients with Parkinson's disease-whose main problems are slowness of movement and
      difficulty walking-will participate in this study. They will be asked to come to the
      laboratory for one experiment. Before and after srTMS treatment, investigators will test
      participants' brain function with a series of psychological tests and an EEG
      (electroencephalogram). The srTMS treatment is performed by placing an insulated coil of wire
      on the scalp and passing a very brief electrical current through the wire coil. The
      experiment will last 2 to 4 hours.
    

Detailed description: 
      The treatment of Parkinson's disease (PD) needs further improvement, particularly in the
      areas of gait and freezing. A promising technique is repetitive transcranial magnetic
      stimulation (rTMS) that, so far, has produced small effects on bradykinesia in drug free
      patients in limited trials. The relevant rTMS parameters for the therapeutic effect are
      unknown. Use of very high rTMS frequency (50 Hz, maximum output of the modern TMS machines,
      super rapid TMS [srTMS] with circular coil design [vs. a figure eight shape]) may further
      improve the therapeutic effect in people who have PD. The 50 Hz srTMS frequency proposed here
      is in a range that exceeds the currently established guidelines since such high frequencies
      have not been investigated. We will look for acute srTMS effects of the primary motor cortex
      (M1) stimulation (60% to 100% motor threshold [MT] intensity, 0.5 seconds to 2 seconds train
      duration). A multi-channel electromyography (EMG) record will be visually controlled for
      signs of increasing time-locked EMG activity, EMG correlates of the spread of excitation
      through M1, or an increase of M1 excitability to establish the safe superrapid transcranial
      magnetic stimulation (srTMS) limit. The electroencephalogram (EEG) Record, Folstein
      Mini-Mental Exam, CFL and FAS Letter Production Test (words beginning with letters 'C', 'F'
      etc), Serial Reaction Time, Grooved Pegboard Test, and Unified PD Rating Scale (UPDRS) will
      be done before and after the srTMS session to control possible srTMS side effects.
    

Intervention name(s): Magstim Rapid Magnetic Stimulator
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Electrical Stimulation; Human Brain; Parkinson Disease; PD