Parkinson DiseaseNCT03059212
rTMS in Facilitation of Working Memory in PD
A study testing rTMS and Cognitive training program in people with Parkinson Disease, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Ten sessions of repetitive transcranial magnetic stimulation yield ability to upregulate the function of primary motor cortex and prefrontal cortex that play key roles in motor and frontal memory processing. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- rTMS and Cognitive training program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Oct 2017to Dec 2021
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson's Disease
- With symptoms of cognitive impairments, such as memory, attention, or language decline.
Who cannot join
- History of seizure attack
- Alzheimer's disease
- With cardiac pacemaker implantation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veteran General Hospital
Taipei, 11217
Po-Yi Tsai, MD, 886-22875729 ext. 3, vivitsai0518@gmail.com
Po-Yi Tsai, MD
About this study
Ten sessions of repetitive transcranial magnetic stimulation yield ability to upregulate the function of primary motor cortex and prefrontal cortex that play key roles in motor and frontal memory processing.
Read the detailed description
Excitatory (>3Hz) rTMS could facilitate the brain cortex and neuroplasticity that benefits motor control and working memory when the coil is applied over primary motor cortex or dorsolateral prefrontal cortex.
- Conditions
- Parkinson Disease
- Being tested
- rTMS, Cognitive training program
- Keywords
- working memory, parkinson's disease, cognition, rTMS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
High frequency rTMS for 3 to 10 min to increase the excitability of cortex.
Cognitive training programBehavioural
A rehabilitation protocol that facilitates attention, memory, execution.
| Study group | Role | What they receive |
|---|---|---|
| High frequency rTMS | Experimental | Real rTMS, one session per day, for 10 days Receives: Device: rTMS |
| High frequency rTMS with cognitive training | Experimental | Real rTMS and cognitive training, one session per day, for 10 days Receives: Device: rTMS; Behavioral: Cognitive training program |
| Sham rTMS | Sham comparator | Sham rTMS, one session per day, for 10 days Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Repeatable Battery for the Assessment of Neuropsychological Status
This battery measures the cognitive functions including attention, memory, language, visuospatial domains.
Measured: up to 12 weeks
Secondary outcomes (1)
Change of Montreal Cognitive Assessment ; MoCA
Assessing cognitive function including delaying recall, attention, executive function, language...
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start30 Oct 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Real rTMS, sham rTMS
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Po-Yi Tsai, MD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059212
- Sponsor's protocol ID
- 2014-10-018A
- Status last verified
- Jan 2021
- First submitted
- 16 Jan 2017
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Preston G, Anderson E, Silva C, Goldberg T, Wassermann EM. Effects of 10 Hz rTMS on the neural efficiency of working memory. J Cogn Neurosci. 2010 Mar;22(3):447-56. doi: 10.1162/jocn.2009.21209.
PubMed 19309294
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rTMS in Facilitation of Working Memory in PD
- ClinicalTrials.gov ID
- NCT03059212
- Acronym / sponsor ID
- 2014-10-018A
- Conditions
- Parkinson Disease
- Keywords
- working memory, parkinson's disease, cognition, rTMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Feb 2017 (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.
Ten sessions of repetitive transcranial magnetic stimulation yield ability to upregulate the function of primary motor cortex and prefrontal cortex that play key roles in motor and frontal memory processing.
Detailed description
Excitatory (>3Hz) rTMS could facilitate the brain cortex and neuroplasticity that benefits motor control and working memory when the coil is applied over primary motor cortex or dorsolateral prefrontal cortex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Real rTMS, sham rTMS
| Arm | Type | Receives |
|---|---|---|
| High frequency rTMS | Experimental | Device: rTMSReal rTMS, one session per day, for 10 days |
| High frequency rTMS with cognitive training | Experimental | Device: rTMS, Behavioral: Cognitive training programReal rTMS and cognitive training, one session per day, for 10 days |
| Sham rTMS | Sham comparator | Device: rTMSSham rTMS, one session per day, for 10 days |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Parkinson's Disease
- With symptoms of cognitive impairments, such as memory, attention, or language decline.
Key exclusion criteria (3 listed)
- History of seizure attack
- Alzheimer's disease
- With cardiac pacemaker implantation
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 |
|---|---|---|
| rTMSHigh frequency rTMS for 3 to 10 min to increase the excitability of cortex. | Device | High frequency rTMS, High frequency rTMS with cognitive training, Sham rTMS |
| Cognitive training programA rehabilitation protocol that facilitates attention, memory, execution. | Behavioural | High frequency rTMS with cognitive training |
Primary outcome
Change of Repeatable Battery for the Assessment of Neuropsychological Status
Time frame: up to 12 weeks
This battery measures the cognitive functions including attention, memory, language, visuospatial domains.
1 secondary outcome
Change of Montreal Cognitive Assessment ; MoCA
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Results publication: PubMed 19309294Preston G, Anderson E, Silva C, Goldberg T, Wassermann EM. Effects of 10 Hz rTMS on the neural efficiency of working memory. J Cogn Neurosci. 2010 Mar;22(3):447-56. doi: 10.1162/jocn.2009.21209.
- Description Related InfoLink provided by the sponsor.
- Description Related InfoLink provided by the sponsor.
- Description Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Po-Yi Tsai, MD principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS and Cognitive training program in people with Parkinson Disease, run by Taipei Veterans General Hospital, Taiwan 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 3 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 8 Jan 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. Some participants in this study may receive a placebo. 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 Po-Yi Tsai, MD (886-22875729 ext. 3, vivitsai0518@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Repeatable Battery for the Assessment of Neuropsychological Status (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03059212, which also lists 1 linked publication.
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 8 Jan 2021.