NCT03243214

Effect of Transcranial Magnetic Stimulation on Cognition and Neural Changes in Parkinson's Disease

Effect of Excitatory Theta-Burst Transcranial Magnetic Stimulation on Cognition in Patients With Both Parkinson's Disease and Mild Cognitive Impairment and Analysis of Functional and Structural Brain Changes After Stimulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Parkinson's Disease
• Mild Cognitive Impairment

Interventions

Type	Name	Description
DEVICE	TMS	Real or Sham TMS will be given to the PD-MCI patient
DEVICE	Sham-TMS	Real or Sham TMS will be given to the PD-MCI patient

Timeline

• Start date: 2016-10-24
• Primary completion: 2020-02-14
• Completion: 2020-02-14
• First posted: 2017-08-08
• Last updated: 2020-10-19

Locations

1 site across 1 country: Canada