Clinical trial NCT03243214: Effect of Transcranial Magnetic Stimulation on Cognition and Neural Changes in Parkinson's Disease
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Mild Cognitive Impairment
Keywords: Transcranial Magnetic Stimulation
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Montreal Neurological Institute and Hospital
name: McGill University
name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-08-08
Enrollment: 41
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is a randomized double blind trial.
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: TMS stimulation applied to the left DLPFC has a quantifiable effect on cognition
timeFrame: Neuropsychological Assessments: Baseline, one day after and one month after TMS stimulation
Secondary outcomes:
measure: Change in structural grey and white matter in the brain at baseline compared to after TMS stimulation
timeFrame: MRI: Baseline and two days after TMS stimulation
measure: Change in executive functioning measured as BOLD fMRI sequence
timeFrame: MRI: Baseline and two days after TMS stimulation
measure: Change in levels of biomarkers of interest (alpha-synuclein and BDNF) in serum after TMS stimulation compared to baseline.
timeFrame: Blood draws: Baseline and two days after TMS stimulation
measure: Genotyping
timeFrame: Blood draw for DNA analysis: Baseline
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary, Department of Clinical Neurosciences
state: Alberta
Study officials:
affiliation: University of Calgary
name: Oury Monchi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lang S, Gan LS, Yoon EJ, Hanganu A, Kibreab M, Cheetham J, Hammer T, Kathol I, Sarna J, Martino D, Monchi O. Theta-Burst Stimulation for Cognitive Enhancement in Parkinson's Disease With Mild Cognitive Impairment: A Randomized, Double-Blind, Sham-Controlled Trial. Front Neurol. 2020 Dec 21;11:584374. doi: 10.3389/fneur.2020.584374. eCollection 2020.