Parkinson Disease With DementiaNCT04698928
The Effect of Repetitive Transcranial Magnetic Stimulation on the Cognition in People With Parkinson's Disease
A study testing Theta burst stimulation in people with Parkinson Disease With Dementia, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Parkinson Disease With Dementia
- What is being tested?
- Theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shuang Ho Hospital
New Taipei City
Chien-Tai Hong, MD, PhD, +886-2-22490088 ext. 8112, ct.hong@tmu.edu.tw
Chientai Hong, MD,PhD
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease With Dementia
- Being tested
- Theta burst stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta burst stimulationDevice
Theta burst stimulation over SMA. 3 section per day, for 5 days, total 15 sections.
| Study group | Role | What they receive |
|---|---|---|
| Theta burst stimulation group | Experimental | Theta burst stimulation over SMA. 3 section per day, for 5 days, total 15 sections. Receives: Device: Theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 months after theta burst stimulation
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.
Measured: Baseline and 1 months after theta burst stimulation
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
Measured: Baseline and 1 months after theta burst stimulation
Change from baseline Category Fluency Test at 1 months after theta burst stimulation
Measure score change on Category Fluency Test
Measured: Baseline and 1 months after theta burst stimulation
Change from baseline Clock Drawing Test at 1 months after theta burst stimulation
Measure score change on Clock Drawing Test
Measured: Baseline and 1 months after theta burst stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease With DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien Tai Hong, Taipei Medical University Shuang Ho Hospital
- Investigators
- Chien-Tai Chien-Tai, MD, PHD, Study chair, Shuang Ho hospital, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698928
- Sponsor's protocol ID
- N202004024
- Status last verified
- Mar 2021
- First submitted
- 22 Nov 2020
- Last updated
- 5 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Some of the participants hesitate to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Repetitive Transcranial Magnetic Stimulation on the Cognition in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04698928
- Acronym / sponsor ID
- N202004024
- Conditions
- Parkinson Disease With Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Theta burst stimulation group | Experimental | Device: Theta burst stimulationTheta burst stimulation over SMA. 3 section per day, for 5 days, total 15 sections. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theta burst stimulationTheta burst stimulation over SMA. 3 section per day, for 5 days, total 15 sections. | Device | Theta burst stimulation group |
Primary outcome
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.
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.
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Individual participant dataSharing planned: No. Some of the participants hesitate to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Tai Chien-Tai, MD, PHD study chair
Shuang Ho hospital, Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theta burst stimulation in people with Parkinson Disease With Dementia, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Tai Chien-Tai, MD, PHD (+886-2-22490088 ext. 8112, ct.hong@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.