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NCT Number: NCT03243214

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

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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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Department of Clinical Neurosciences

Calgary, Alberta, T2N 4N1, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TMS

Device

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

Other names: Magstim

Sham-TMS

Device

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

Primary outcomes

  1. TMS stimulation applied to the left DLPFC has a quantifiable effect on cognition

    Time frame: Neuropsychological Assessments: Baseline, one day after and one month after TMS stimulation

    Changes in one or more of the five assessed brain domains at baseline and one day after stimulation will be measured by comparing the scores for the different neuropsychological tests.

    The same neuropsychological assessment one month after TMS stimulation will show, if possible changes from one day after are longer lasting and can still be seen.

Secondary outcomes

  1. Change in structural grey and white matter in the brain at baseline compared to after TMS stimulation

    Time frame: MRI: Baseline and two days after TMS stimulation

    MRI analysis will measure any changes in cortical thickness (mm) or other structural changes in the brain after TMS or Sham-TMS stimulation

  2. Change in executive functioning measured as BOLD fMRI sequence

    Time frame: MRI: Baseline and two days after TMS stimulation

    The executive task, Wisconsin Card Sorting Task, will be performed in the scanner to measure the level of activation in the basal ganglia and the prefrontal cortex via BOLD functional MRI sequence to see changes after TMS stimulation compared to baseline.

  3. Change in levels of biomarkers of interest (alpha-synuclein and BDNF) in serum after TMS stimulation compared to baseline.

    Time frame: Blood draws: Baseline and two days after TMS stimulation

    Measure the concentration of alpha-synuclein and BDNF in serum at baseline and after TMS stimulation with the Meso Scale Discovery method. These assays are highly developed ELISA assays using electrochemiluminescence.

  4. Genotyping

    Time frame: Blood draw for DNA analysis: Baseline

    Analyze DNA for following genes: COMT, DAT1, MAPT, ApoE, GBA, CHCRA4, SNCA, BDNF These genes of interest will be correlated to changes in the neuropsychological assessments.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • McGill University
  • Montreal Neurological Institute and Hospital

Registry information

Official study title

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

Acronym: PD-MCI-TMS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 8, 2017
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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