The Effect of Repetitive Transcranial Magnetic Stimulation on the Cognition in People With Parkinson's Disease
Primary Purpose
Parkinson Disease With Dementia
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Theta burst stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease With Dementia
Eligibility Criteria
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
Sites / Locations
- Shuang Ho HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Theta burst stimulation group
Arm Description
Theta burst stimulation over SMA. 3 section per day, for 5 days, total 15 sections.
Outcomes
Primary Outcome Measures
Change from baseline Mini-Mental State Examination (MMSE) score at 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.
Change from baseline Wechsler Memory Scale (WMS) score at 1 months after theta burst stimulation
Measure score change on Wechsler Memory Scale (WMS). Higher score means better outcome.
Change from baseline Trial Making Test A and B at 1 months after theta burst stimulation
Measure score change on Trial Making Test A and B
Change from baseline Category Fluency Test at 1 months after theta burst stimulation
Measure score change on Category Fluency Test
Change from baseline Clock Drawing Test at 1 months after theta burst stimulation
Measure score change on Clock Drawing Test
Secondary Outcome Measures
Full Information
NCT ID
NCT04698928
First Posted
November 22, 2020
Last Updated
March 31, 2021
Sponsor
Taipei Medical University Shuang Ho Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04698928
Brief Title
The Effect of Repetitive Transcranial Magnetic Stimulation on the Cognition in People With Parkinson's Disease
Official Title
The Effect of Repetitive Transcranial Magnetic Stimulation on the Cognition in People With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease With Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Theta burst stimulation group
Arm Type
Experimental
Arm Description
Theta burst stimulation over SMA. 3 section per day, for 5 days, total 15 sections.
Intervention Type
Device
Intervention Name(s)
Theta burst stimulation
Intervention Description
Theta burst stimulation over SMA. 3 section per day, for 5 days, total 15 sections.
Primary Outcome Measure Information:
Title
Change from baseline Mini-Mental State Examination (MMSE) score at 1 months after theta burst stimulation
Description
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.
Time Frame
Baseline and 1 months after theta burst stimulation
Title
Change from baseline Wechsler Memory Scale (WMS) score at 1 months after theta burst stimulation
Description
Measure score change on Wechsler Memory Scale (WMS). Higher score means better outcome.
Time Frame
Baseline and 1 months after theta burst stimulation
Title
Change from baseline Trial Making Test A and B at 1 months after theta burst stimulation
Description
Measure score change on Trial Making Test A and B
Time Frame
Baseline and 1 months after theta burst stimulation
Title
Change from baseline Category Fluency Test at 1 months after theta burst stimulation
Description
Measure score change on Category Fluency Test
Time Frame
Baseline and 1 months after theta burst stimulation
Title
Change from baseline Clock Drawing Test at 1 months after theta burst stimulation
Description
Measure score change on Clock Drawing Test
Time Frame
Baseline and 1 months after theta burst stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-Tai Chien-Tai, MD, PHD
Phone
+886-2-22490088
Ext
8112
Email
ct.hong@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Tai Chien-Tai, MD, PHD
Organizational Affiliation
Shuang Ho hospital, Taipei Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Shuang Ho Hospital
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Tai Hong, MD, PhD
Phone
+886-2-22490088
Ext
8112
Email
ct.hong@tmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Chientai Hong, MD,PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Some of the participants hesitate to share IPD.
Learn more about this trial
The Effect of Repetitive Transcranial Magnetic Stimulation on the Cognition in People With Parkinson's Disease
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