Effect of Transcranial Magnetic Stimulation on Cognition and Neural Changes in Parkinson's Disease (PD-MCI-TMS)

University of Calgary

Status: Completed

Conditions: Mild Cognitive Impairment; Parkinson's Disease

Treatments: Device: TMS; Device: Sham-TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03243214

REB15-1689

Details and patient eligibility

About

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.

Full 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

Enrollment: 41 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of idiopathic Parkinson's disease any stage
• Mild Cognitive Behaviour confirmed through neuropsychological assessment
• MRI Compatibility

Exclusion criteria

• Alcohol-dependency
• Severe psychiatric disorder, neurological disorder, epilepsy or stroke
• General anaesthesia in the past six months
• History of cerebrovascular disorders
• Colour-blindness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

---

41 participants in 2 patient groups

PD-MCI, TMS

Active Comparator group

Description:

The patient is treated with TMS stimulation according to protocol with an active coil.

Treatment:

Device: TMS

PD-MCI, Sham-TMS

Sham Comparator group

Description:

The patient is treated with Sham-TMS stimulation according to protocol with an inactive coil.

Treatment:

Device: Sham-TMS