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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-24

Study Completion Date

2020-02-14

Brief Summary

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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.

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Detailed Description

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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

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Parkinson's Disease Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This is a randomized double blind trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The participant and investigator do not know what treatment is applied (TMS stimulation or Sham-TMS stimulation with a different coil).

The outcomes assessor will also be blinded.

Study Groups

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PD-MCI, TMS

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

Group Type ACTIVE_COMPARATOR

TMS

Intervention Type DEVICE

Real or Sham TMS will be given to the PD-MCI patient

PD-MCI, Sham-TMS

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

Group Type SHAM_COMPARATOR

Sham-TMS

Intervention Type DEVICE

Real or Sham TMS will be given to the PD-MCI patient

Interventions

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TMS

Real or Sham TMS will be given to the PD-MCI patient

Intervention Type DEVICE

Sham-TMS

Real or Sham TMS will be given to the PD-MCI patient

Intervention Type DEVICE

Other Intervention Names

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Magstim

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No