- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04698928
The Effect of Repetitive Transcranial Magnetic Stimulation on the Cognition in People With Parkinson's Disease
March 31, 2021 updated by: Chien Tai Hong, Taipei Medical University Shuang Ho Hospital
Parkinson's disease (PD) is the second most common neurodegenerative disease.
The cardinal symptoms of PD are tremor, rigidity, bradykinesia and postural instability.
Cognitive impairment and dementia are also one of the key features of the non-motor symptoms of PD.
At present, the mainstream treatment of PD-dementia is the dopaminergic rivastigmine.
Repetitive transcortical magnetic stimulation (rTMS) is a novel non-invasive intervention.
Through the magnetic stimulation, brain neurons could be activated by the electrical current.
The application of rTMS had been approved by US FDA for the treatment of depression.
The possible effect of rTMS may result from the stimulation-related neuronal plasticity.
Regarding PD, rTMS also had been found to had some effect on different motor symptoms and cognition.
The present study would like to test the accumulative effect of rTMS on cognition of PD.
All the study subjects will receive rTMS under intermittent theta burst stimulation (iTBS) mode at supplementary motor area (SMA).
Cognitive bahevorial tests and other motor/depression assessments will be assessed before and after the intervention.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The present trial is designed as an open-label, uncontrolled pilot study for evaluating the effect of rTMS on cognitive function in people with Parkinson disease (PD).
The primary endpoint is the change of cognitive function, and the secondary endpoint is the improvement of motor symptoms.
All participants need to complete the informed consent before they are enrolled into the trial.
Preliminary data including age, sex, education, employment, medical history, drug history, disease duration, modified Hoehn-Yahr stage, and UPDRS score are collected.
Cognitive function including mini-mental state examination (MMSE), clocking drawing test, Wechsler memory scale (WMS)-world list test and spatial span test, trial making test A and B, category fluency test (animal naming), and beck depression inventory-II are tested by trained neuropsychiatrists.
Gait function are evaluated with time up and go (TUG), freezing of gait questionnaire (FOG-Q), and Gait-up device analysis before trial starting.
Pre-treatment brain image examined by magnetic resonance image (MRI) and blood sampling for synapse protein level are performed.
The participants are then arranged to receive theta burst stimulation for 5 days by using Magstim machine (Super Rapid 2) equipped with air cooled coil (D70), stimulating on supplementary motor area (SMA).
After the intervention, post-treatment evaluation including cognition, motor symptoms, gait function, brain MRI, and blood sampling will be performed again with the same methods at 1 month later.
Any adverse event during the trial period will also be recorded.
The trial is expected to be conducted in Shuange-Ho hospital, Taipei Medical University.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chien-Tai Chien-Tai, MD, PHD
- Phone Number: 8112 +886-2-22490088
- Email: ct.hong@tmu.edu.tw
Study Locations
-
-
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New Taipei City, Taiwan
- Recruiting
- Shuang Ho Hospital
-
Principal Investigator:
- Chientai Hong, MD,PhD
-
Contact:
- Chien-Tai Hong, MD, PhD
- Phone Number: 8112 +886-2-22490088
- Email: ct.hong@tmu.edu.tw
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
43 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Fulfill the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease, age between 45-80 years old.
- With mild cognitive impairment or dementia (Clinical Dementia Rating Scale >= 0.5)
Exclusion Criteria:
- People who have
- pre-existing and active major neurological diseases other than PD
- with a previous history of seizures
- with implanted metallic objects that would contraindicate rTMS
- unable to perform fMRI
- with skin damage on the stimulation area
- with multiple sclerosis
- with large ischemic scars
- with a family history or medical history of seizures, epilepsy
- brain damage may affect the threshold for inducing epilepsy
- taken tricyclic antidepressants, analgesics, or anything that may lower the threshold for inducing epilepsy
- with sleep disorders during the rTMS treatment
- with severe alcohol abuse or use of epilepsy drugs
- with severe heart disease or uncontrollable migraine caused by high intracranial pressure
- who are actively suicidal during the trial period, have recurring major medical disorders, or with neurological co-morbidities such as space occupying lesions, CVA, aneurysms etc
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Theta burst stimulation group
Theta burst stimulation over SMA. 3 section per day, for 5 days, total 15 sections.
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Theta burst stimulation over SMA. 3 section per day, for 5 days, total 15 sections.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline Mini-Mental State Examination (MMSE) score at 1 months after theta burst stimulation
Time Frame: Baseline and 1 months after theta burst stimulation
|
Measure score change on Mini-Mental State Examination.
The maximum score is 30 and the minimum score is 0, with higher score means better outcome.
|
Baseline and 1 months after theta burst stimulation
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Change from baseline Wechsler Memory Scale (WMS) score at 1 months after theta burst stimulation
Time Frame: Baseline and 1 months after theta burst stimulation
|
Measure score change on Wechsler Memory Scale (WMS).
Higher score means better outcome.
|
Baseline and 1 months after theta burst stimulation
|
Change from baseline Trial Making Test A and B at 1 months after theta burst stimulation
Time Frame: Baseline and 1 months after theta burst stimulation
|
Measure score change on Trial Making Test A and B
|
Baseline and 1 months after theta burst stimulation
|
Change from baseline Category Fluency Test at 1 months after theta burst stimulation
Time Frame: Baseline and 1 months after theta burst stimulation
|
Measure score change on Category Fluency Test
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Baseline and 1 months after theta burst stimulation
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Change from baseline Clock Drawing Test at 1 months after theta burst stimulation
Time Frame: Baseline and 1 months after theta burst stimulation
|
Measure score change on Clock Drawing Test
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Baseline and 1 months after theta burst stimulation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Chien-Tai Chien-Tai, MD, PHD, Shuang Ho Hospital, Taipei Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
March 31, 2023
Study Registration Dates
First Submitted
November 22, 2020
First Submitted That Met QC Criteria
January 5, 2021
First Posted (Actual)
January 7, 2021
Study Record Updates
Last Update Posted (Actual)
April 5, 2021
Last Update Submitted That Met QC Criteria
March 31, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N202004024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Some of the participants hesitate to share IPD.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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