Effect of Transcranial Magnetic Stimulation on Cognition and Neural Changes in Parkinson's Disease
Condition: Parkinson's Disease; Mild Cognitive Impairment
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Parkinson's disease (PD) affects more than 100,000 Canadians and results in symptoms
      affecting both motor and cognitive (thinking and memory) functions. Parkinson's disease with
      Mild Cognitive Impairment (MCI) frequently results in development of dementia for which few
      treatment options exist. Transcranial Magnetic Stimulation (TMS) is used to alter activity in
      the outer regions of the brain and has been shown in previous studies to increase cognitive
      performance in patients with different disorders. This study will investigate the
      effectiveness of TMS as a clinical treatment for the cognitive deficits associated with
      Parkinson's disease. 64 male and female participants between the ages of 50 and 90 will
      attend eight study visits over a period of 63 to 66 days. This study is a double-blind
      randomized clinical trial meaning the participant will be assigned by chance to either the
      TMS-treatment group or the Sham-treatment group. Additionally, a combination of memory and
      thinking tests and Magnetic Resonance Imaging (MRI) will be used to see if there are
      structural and functional changes within the brain. Genotyping and blood analysis before and
      after treatment for different biomarkers will also be performed and these data will be
      compared to the TMS data. Initially, this research will increase knowledge about the effects
      of TMS on various brain regions. Ultimately, we will be able to determine if TMS can be used
      as a complementary therapy for PD to improve cognitive performance and to reduce progression
      into dementia.
    

Detailed description: 
      Visit 1:

      Informed Consent Neuropsychological Battery

      Visit 2: (1-2 days later) Blood Draw Neuropsychiatric Assessment Questionnaires Companion
      Questionnaire to take home UPDRS

      Visit 3: (up to a week after visit 2) MRI Scan while performing Executive Task

      Visit 4: (1-3 days after visit 3) TMS- or Sham-Treatment (two sessions , 20 min each, 1 hour
      apart)

      Visit 5: (2-3 days after visit 4) Same as Visit 4

      Visit 6: (2-3 days after visit 5) Same as Visit 4

      Visit 7: (1 day after visit 6) Neuropsychological Battery UPDRS

      Visit 8: (1 day after visit 7) MRI Scan while performing Executive Task Blood Draw

      Visit 9: (1 month after visit 6) Neuropsychological Battery UPDRS
    

Intervention name(s): TMS; Sham-TMS
Intervention type(s): Device; Device
Intervention description(s): Real or Sham TMS will be given to the PD-MCI patient; Real or Sham TMS will be given to the PD-MCI patient
Other intervention name(s): Magstim
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a randomized double blind trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Magnetic Stimulation