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

NCT03243214 | Completed

• 1 other identifier: REB15-1689
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Parkinson's Disease

Keywords

Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (4)

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

  MRI: Baseline and two days after TMS stimulation

• Change in executive functioning measured as BOLD fMRI sequence

  MRI: Baseline and two days after TMS stimulation

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

  Blood draws: Baseline and two days after TMS stimulation

• Genotyping

  Blood draw for DNA analysis: Baseline

Study Arms (2)

PD-MCI, TMS

ACTIVE COMPARATOR

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

Device: TMS

PD-MCI, Sham-TMS

SHAM COMPARATOR

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

Device: Sham-TMS

Interventions

TMS DEVICE

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

Also known as: Magstim

PD-MCI, TMS

Sham-TMS DEVICE

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

PD-MCI, Sham-TMS

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

University of Calgary, Department of Clinical Neurosciences

Calgary, Alberta, T2N 4N1, Canada

Location

Related Publications (1)

• 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.

  PMID: 33408684 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Oury Monchi, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Tourmaline Chair in Parkinson's Disease

Model Details: This is a randomized double blind trial.

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 8, 2017
• Study Start: October 24, 2016
• Primary Completion: February 14, 2020
• Study Completion: February 14, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

CA (1)