Central Nervous System DiseasesNCT02006615
The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory
A study testing Functional near infrared spectroscopy and rTMS in people with Central Nervous System Diseases, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
The investigators hypothesize that 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 80 years
- Conditions the study is for
- Central Nervous System Diseases
- What is being tested?
- Functional near infrared spectroscopy and rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Jun 2017to 11 Jul 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic or hemorrhagic cerebrovascular lesion,
- Parkinson's disease
Who cannot join
- Seizure
- With metal implantation
- Dementia or severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Po-Yi Tsai, MD, 886-228757293, vivitsai0518@gmail.com
About this study
Official title: The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory in Stroke, Parkinson, and Elderly Patients
The investigators hypothesize that 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 gyrus.
- Conditions
- Central Nervous System Diseases
- Being tested
- Functional near infrared spectroscopy, rTMS
- Medical subject headings
- Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional near infrared spectroscopyDevice
Also called fNIRS
Using high-sensitivity infrared to detect the active brain areas
rTMSDevice
To modulate brain cortex
| Study group | Role | What they receive |
|---|---|---|
| High frequency rTMS plus fNIRS | Experimental | rTMS with neuroimage assessment of functional near infrared spectroscopy Receives: Device: Functional near infrared spectroscopy; Device: rTMS |
| Sham rTMS | Sham comparator | Sham stimulation Receives: Device: rTMS |
| High frequency rTMS | Experimental | High frequency rTMS to modulate brain areas 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
Test cognition including memory, attention, language...
Measured: Up to 12 weeks
Secondary outcomes (2)
Change of Montreal Cognitive Assessment
Test cognition including memory, attention, and language.
Measured: Up to 12 weeks
Change of Fugl-Meyer Assessment , Wolf Motor Function Test
Test upper limb motor function.
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 posted10 Dec 2013 (estimated)
- Study start2 Jun 2017
- Primary completion11 Jul 2021 (estimated)
- Study completion11 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Central Nervous System DiseasesStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 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
- NCT02006615
- Sponsor's protocol ID
- 2013-07-011A
- Status last verified
- Jan 2021
- First submitted
- 5 Dec 2013
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chang PW, Lu CF, Chang ST, Tsai PY. Functional Near-Infrared Spectroscopy as a Target Navigator for rTMS Modulation in Patients with Hemiplegia: A Randomized Control Study. Neurol Ther. 2022 Mar;11(1):103-121. doi: 10.1007/s40120-021-00300-0. Epub 2021 Nov 13.
PubMed 34773596Tsai PY, Lin WS, Tsai KT, Kuo CY, Lin PH. High-frequency versus theta burst transcranial magnetic stimulation for the treatment of poststroke cognitive impairment in humans. J Psychiatry Neurosci. 2020 Jul 1;45(4):262-270. doi: 10.1503/jpn.190060.
PubMed 32159313Lai CJ, Wang CP, Tsai PY, Chan RC, Lin SH, Lin FG, Hsieh CY. Corticospinal integrity and motor impairment predict outcomes after excitatory repetitive transcranial magnetic stimulation: a preliminary study. Arch Phys Med Rehabil. 2015 Jan;96(1):69-75. doi: 10.1016/j.apmr.2014.08.014. Epub 2014 Sep 11.
PubMed 25218256
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory in Stroke, Parkinson, and Elderly Patients
- ClinicalTrials.gov ID
- NCT02006615
- Acronym / sponsor ID
- 2013-07-011A
- Conditions
- Central Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 11 Jul 2021 (estimated)
- Study completion
- 11 Jul 2021 (estimated)
- First posted
- 10 Dec 2013 (estimated)
- 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.
The investigators hypothesize that 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 gyrus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High frequency rTMS plus fNIRS | Experimental | Device: Functional near infrared spectroscopy, Device: rTMSrTMS with neuroimage assessment of functional near infrared spectroscopy |
| Sham rTMS | Sham comparator | Device: rTMSSham stimulation |
| High frequency rTMS | Experimental | Device: rTMSHigh frequency rTMS to modulate brain areas |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ischemic or hemorrhagic cerebrovascular lesion,
- Parkinson's disease
Key exclusion criteria (3 listed)
- Seizure
- With metal implantation
- Dementia or severe cognitive impairment
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 |
|---|---|---|
| Functional near infrared spectroscopyAlso: fNIRSUsing high-sensitivity infrared to detect the active brain areas | Device | High frequency rTMS plus fNIRS |
| rTMSTo modulate brain cortex | Device | High frequency rTMS, High frequency rTMS plus fNIRS, Sham rTMS |
Primary outcome
Change of Repeatable Battery for the Assessment of Neuropsychological Status
Time frame: Up to 12 weeks
Test cognition including memory, attention, language...
2 secondary outcomes
Change of Montreal Cognitive Assessment
Time frame: Up to 12 weeks
Change of Fugl-Meyer Assessment , Wolf Motor Function Test
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 11 Jan 2021.
- Derived from this study: PubMed 34773596Chang PW, Lu CF, Chang ST, Tsai PY. Functional Near-Infrared Spectroscopy as a Target Navigator for rTMS Modulation in Patients with Hemiplegia: A Randomized Control Study. Neurol Ther. 2022 Mar;11(1):103-121. doi: 10.1007/s40120-021-00300-0. Epub 2021 Nov 13.
- Derived from this study: PubMed 32159313Tsai PY, Lin WS, Tsai KT, Kuo CY, Lin PH. High-frequency versus theta burst transcranial magnetic stimulation for the treatment of poststroke cognitive impairment in humans. J Psychiatry Neurosci. 2020 Jul 1;45(4):262-270. doi: 10.1503/jpn.190060.
- Derived from this study: PubMed 25218256Lai CJ, Wang CP, Tsai PY, Chan RC, Lin SH, Lin FG, Hsieh CY. Corticospinal integrity and motor impairment predict outcomes after excitatory repetitive transcranial magnetic stimulation: a preliminary study. Arch Phys Med Rehabil. 2015 Jan;96(1):69-75. doi: 10.1016/j.apmr.2014.08.014. Epub 2014 Sep 11.
- Document of rTMS effect in functional facilitationLink provided by the sponsor.
- Document of rTMS effect in functional facilitationLink provided by the sponsor.
- Document of rTMS effect in functional facilitationLink provided by the sponsor.
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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 Functional near infrared spectroscopy and rTMS in people with Central Nervous System Diseases, 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 11 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 (886-228757293, 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 NCT02006615, which also lists 3 linked publications.
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 11 Jan 2021.