Parkinson DiseaseNCT05478057
Supplementary Motor Area is a Potential Target for Speech Disturbance in Parkinson Disease
A study testing "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system in people with Parkinson Disease, run by Chang Gung Memorial Hospital.
Trial summary
Speech disturbance is common in patients with Parkinson disease. Pharmacotherapy improves motor symptoms but has inconsistent effects on speech disturbance in PD patients. Transcranial magnetic stimulation (TMS) is a safe and non-invasive tool used for brain stimulation. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 31 Dec 2025
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- right-handed healthy adult volunteers who understand and agree on the informed consent of the study
- PD patients with speech disturbance who understand and agree on the informed consent of the study. The speech item scored 2 or 3 in the unified Parkinson's disease rating scale (UPDRS) part III.
Who cannot join
- pregnancy or possibility of pregnancy
- history of seizure
- family history of epilepsy
- metals in any part of the body.
- Experiment 2
- dementia
Show all 9Show fewer
- the history of stroke, brain lesion, other central nervous system diseases
- the contraindication of TMS which described above
- any contraindication of MRI
About this study
Speech disturbance is common in patients with Parkinson disease. Pharmacotherapy improves motor symptoms but has inconsistent effects on speech disturbance in PD patients. Transcranial magnetic stimulation (TMS) is a safe and non-invasive tool used for brain stimulation. Repetitive transcranial magnetic stimulation (rTMS) has positive effects on motor function of PD. Yet, its effect on speech disturbance seems to be inconclusive. Previous rTMS studies mainly focused on the primary motor cortex for PD speech disturbance. Nevertheless, we think supplementary motor area (SMA) may be a better target. Speech disturbance in PD may be associated with basal ganglia-thalamocortical motor circuits and SMA involves in the cortex part. In addition, neuroimaging studies showed that SMA were under-activation in PD patients. Therefore, we conduct this 3-year study including two experiments. The aim of the study is to determine if rTMS over SMA can improve the speech function of PD patients and change the functional connectivity of speech pathway in the brain. This will be the first study to investigate the effect of rTMS over SMA on speech.
- Conditions
- Parkinson Disease
- Being tested
- "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system
- Keywords
- speech disturbance, transcranial magnetic stimulation
- Medical subject headings
- Parkinson Disease, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) systemDevice
we plan to recruit 60 patients with Parkinson disease, comprising 30 patients with speech disturbance and 30 age- and sex-match patients without speech disturbance. Each group of patients will be randomly divided into sham stimulation or rTMS. A total of 10 rTMS sessions will be applied in 2 weeks. The effect of rTMS will be evaluated via the changes of speech performance and functional connectivity which was analyzed from resting-state functional magnetic resonance imaging.
| Study group | Role | What they receive |
|---|---|---|
| PD patients with speech disturbance treated with 10 Hz rTMS | Experimental | Not described Receives: Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system |
| PD patients with speech disturbance treated with sham rTMS | Sham comparator | Not described Receives: Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system |
| PD patients without speech disturbance treated with 10 Hz rTMS | Experimental | Not described Receives: Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system |
| PD patients without speech disturbance with sham rTMS | Sham comparator | Not described Receives: Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of speech performance from baseline in experiment 1
- sustained phonation of /a/ for as long and steady as possible in one breath
- fast pa-/ta-/ka- repetition at least nine times in one breath
- reading a standardized paragraph composed of 80 words as clear and fast as possible
Measured: Baseline ((1) before rTMS), (2) immediately after rTMS
Change of speech performance from baseline in experiment 2
- sustained phonation of /a/ for as long and steady as possible in one breath
- fast pa-/ta-/ka- repetition at least nine times in one breath
- reading a standardized paragraph composed of 80 words as clear and fast as possible
Measured: Baseline ((1) before rTMS), (2) within 24 hours after 10 times of rTMS (3) 8 weeks later after 10 times of rTMS
Change of functional connectivity from baseline in experiment 2
use rs-fMRI to compare the functional connectivity between PD patients with and without speech disturbance and the changes of connectivity after rTMS over SMA
Measured: Baseline ((1) before rTMS), (2) within 24 hours after 10 times of rTMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478057
- Sponsor's protocol ID
- 202102465A3A0
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementary Motor Area is a Potential Target for Speech Disturbance in Parkinson Disease
- ClinicalTrials.gov ID
- NCT05478057
- Acronym / sponsor ID
- 202102465A3A0
- Conditions
- Parkinson Disease
- Keywords
- speech disturbance, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Jul 2022 (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.
Speech disturbance is common in patients with Parkinson disease. Pharmacotherapy improves motor symptoms but has inconsistent effects on speech disturbance in PD patients. Transcranial magnetic stimulation (TMS) is a safe and non-invasive tool used for brain stimulation. Repetitive transcranial magnetic stimulation (rTMS) has positive effects on motor function of PD. Yet, its effect on speech disturbance seems to be inconclusive. Previous rTMS studies mainly focused on the primary motor cortex for PD speech disturbance. Nevertheless, we think supplementary motor area (SMA) may be a better target. Speech disturbance in PD may be associated with basal ganglia-thalamocortical motor circuits and SMA involves in the cortex part. In addition, neuroimaging studies showed that SMA were under-activation in PD patients. Therefore, we conduct this 3-year study including two experiments. The aim of the study is to determine if rTMS over SMA can improve the speech function of PD patients and change the functional connectivity of speech pathway in the brain. This will be the first study to investigate the effect of rTMS over SMA on speech.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PD patients with speech disturbance treated with 10 Hz rTMS | Experimental | Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system |
| PD patients with speech disturbance treated with sham rTMS | Sham comparator | Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system |
| PD patients without speech disturbance treated with 10 Hz rTMS | Experimental | Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system |
| PD patients without speech disturbance with sham rTMS | Sham comparator | Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- right-handed healthy adult volunteers who understand and agree on the informed consent of the study
- PD patients with speech disturbance who understand and agree on the informed consent of the study. The speech item scored 2 or 3 in the unified Parkinson's disease rating scale (UPDRS) part III.
Key exclusion criteria (9 listed)
- pregnancy or possibility of pregnancy
- history of seizure
- family history of epilepsy
- metals in any part of the body.
- Experiment 2
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 |
|---|---|---|
| "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) systemwe plan to recruit 60 patients with Parkinson disease, comprising 30 patients with speech disturbance and 30 age- and sex-match patients without speech disturbance. Each group of patients will be randomly divided into sham stimulation or rTMS. A total of 10 rTMS sessions will be applied in 2 weeks. The effect of rTMS will be evaluated via the changes of speech performance and functional connectivity which was analyzed from resting-state functional magnetic resonance imaging. | Device | PD patients with speech disturbance treated with 10 Hz rTMS, PD patients with speech disturbance treated with sham rTMS, PD patients without speech disturbance treated with 10 Hz rTMS, PD patients without speech disturbance with sham rTMS |
Primary outcome
Change of speech performance from baseline in experiment 1
Time frame: Baseline ((1) before rTMS), (2) immediately after rTMS
1. sustained phonation of /a/ for as long and steady as possible in one breath 2. fast pa-/ta-/ka- repetition at least nine times in one breath 3. reading a standardized paragraph composed of 80 words as clear and fast as possible
Change of speech performance from baseline in experiment 2
Time frame: Baseline ((1) before rTMS), (2) within 24 hours after 10 times of rTMS (3) 8 weeks later after 10 times of rTMS
1. sustained phonation of /a/ for as long and steady as possible in one breath 2. fast pa-/ta-/ka- repetition at least nine times in one breath 3. reading a standardized paragraph composed of 80 words as clear and fast as possible
Change of functional connectivity from baseline in experiment 2
Time frame: Baseline ((1) before rTMS), (2) within 24 hours after 10 times of rTMS
use rs-fMRI to compare the functional connectivity between PD patients with and without speech disturbance and the changes of connectivity after rTMS over SMA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system in people with Parkinson Disease, run by Chang Gung Memorial Hospital.
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 9 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 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of speech performance from baseline in experiment 1 (time frame: Baseline ((1) before rTMS), (2) immediately after rTMS). The study lists 3 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 28 Jul 2022.