Parkinson DiseaseNCT04203615
Effect of Noninvasive Brain Stimulation on Hypokinetic Dysarthria in Parkinson's Disease
A study testing Transcranial magnetic stimulation- real rTMS in people with Parkinson Disease, run by Masaryk University at 1 site in Czechia.
Trial summary
Hypokinetic dysarthria (HD) is common in Parkinson's disease (PD) patients and responds only partially to pharmacotherapy and surgery. The investigators will explore long-term effects of repetitive transcranial magnetic stimulation (rTMS) applied over right superior temporal gyrus, brain area known to be engaged in… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcranial magnetic stimulation- real rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jul 2019to 30 Jan 2020
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with clinically established PD (Postuma et al. 2016)
Who cannot join
- psychiatric disorders, including major depression, hallucinations
- any MRI-incompatible metal in the body
- epilepsy
- lack of cooperation
- presence of dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Noninvasive Brain Stimulation on Hypokinetic Dysarthria and Brain Plasticity in Parkinson's Disease
Hypokinetic dysarthria (HD) is common in Parkinson's disease (PD) patients and responds only partially to pharmacotherapy and surgery. The investigators will explore long-term effects of repetitive transcranial magnetic stimulation (rTMS) applied over right superior temporal gyrus, brain area known to be engaged in the feedback control of voiced speech. The project results will allow for the identification of potential therapeutic effects of rTMS as a tool that could contribute to the speech therapy of HD in PD patients. The results will also enhance our understanding of brain mechanisms underlying specific long-term effects of rTMS.
Read the detailed description
A two parallel group, randomized, placebo controlled design will be used. Twenty PD patients will be stimulated in a two weeks long therapeutical sessions (10 sessions). Other twenty PD patients will be stimulated with the same protocol using sham stimulation. An MRI protocol consisting of T1, EPI BOLD, and DTI (diffusion tensor imaging) sequences and speech evaluation (acoustic signal processing and 3F test) will be performed prior to and after 10 days of rTMS and then repeated after 4, 8 and 12 weeks.
- Conditions
- Parkinson Disease
- Being tested
- Transcranial magnetic stimulation- sham rTMS, Transcranial magnetic stimulation- real 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.
Transcranial magnetic stimulation- sham rTMSDevice
Transcranial magnetic stimulation- sham figure-eight coil will be used for stimulation. This sham coil will generate only clicking noise and will not generate any magnetic field.
Transcranial magnetic stimulation- real rTMSDevice
Transcranial magnetic stimulation- figure-eight coil will be used for stimulation. 1 Hz stimulation, 100% of Resting Motor Threshold will be used.
| Study group | Role | What they receive |
|---|---|---|
| PD patients with real rTMS | Active comparator | Patients will receive real rTMS in a two weeks long sessions (10 sessions). Receives: Device: Transcranial magnetic stimulation- real rTMS |
| PD patients with sham rTMS | Sham comparator | Patients will receive sham rTMS in a two weeks long sessions (10 sessions). Receives: Device: Transcranial magnetic stimulation- sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in score of the 3F Test (the unabbreviated title- "the 3F Test Dysarthric Profile")
The 3F Test Dysarthric Profile enables clinicians to characterize a wide range of signs and symptoms of dysarthria. The minimum value of this scale is 0 (anarthria), the maximum value is 90 (no disorder). Higher scores of this scale mean better outcome. This test will be administrated by speech pathologist.
Measured: On the beginning of the study, after completion of two weeks stimulation, 4,8 and 12 weeks after completion of stimulation sessions.
Secondary outcomes (1)
Resting state
The effect of stimulation on the resting state networks will be studied using fMRI measurement.
Measured: On the beginning of the study, after completion of two weeks stimulation, 4,8 and 12 weeks after completion of stimulation sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Jul 2019
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
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.
- 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
- A two parallel group, randomized, placebo controlled design will be used. Twenty PD patients will be stimulated in a two weeks long therapeutical sessions (10 sessions). Other twenty PD patients will be stimulated with the same protocol using sham stimulation.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203615
- Sponsor's protocol ID
- NV16-30805A
- Status last verified
- Sep 2020
- First submitted
- 9 Dec 2019
- Last updated
- 2 Sep 2020
- 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 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Noninvasive Brain Stimulation on Hypokinetic Dysarthria and Brain Plasticity in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04203615
- Acronym / sponsor ID
- NV16-30805A
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 18 Dec 2019 (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.
Hypokinetic dysarthria (HD) is common in Parkinson's disease (PD) patients and responds only partially to pharmacotherapy and surgery. The investigators will explore long-term effects of repetitive transcranial magnetic stimulation (rTMS) applied over right superior temporal gyrus, brain area known to be engaged in the feedback control of voiced speech. The project results will allow for the identification of potential therapeutic effects of rTMS as a tool that could contribute to the speech therapy of HD in PD patients. The results will also enhance our understanding of brain mechanisms underlying specific long-term effects of rTMS.
Detailed description
A two parallel group, randomized, placebo controlled design will be used. Twenty PD patients will be stimulated in a two weeks long therapeutical sessions (10 sessions). Other twenty PD patients will be stimulated with the same protocol using sham stimulation. An MRI protocol consisting of T1, EPI BOLD, and DTI (diffusion tensor imaging) sequences and speech evaluation (acoustic signal processing and 3F test) will be performed prior to and after 10 days of rTMS and then repeated after 4, 8 and 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A two parallel group, randomized, placebo controlled design will be used. Twenty PD patients will be stimulated in a two weeks long therapeutical sessions (10 sessions). Other twenty PD patients will be stimulated with the same protocol using sham stimulation.
| Arm | Type | Receives |
|---|---|---|
| PD patients with real rTMS | Active comparator | Device: Transcranial magnetic stimulation- real rTMSPatients will receive real rTMS in a two weeks long sessions (10 sessions). |
| PD patients with sham rTMS | Sham comparator | Device: Transcranial magnetic stimulation- sham rTMSPatients will receive sham rTMS in a two weeks long sessions (10 sessions). |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with clinically established PD (Postuma et al. 2016)
Key exclusion criteria (5 listed)
- psychiatric disorders, including major depression, hallucinations
- any MRI-incompatible metal in the body
- epilepsy
- lack of cooperation
- presence of dementia
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 |
|---|---|---|
| Transcranial magnetic stimulation- sham rTMSTranscranial magnetic stimulation- sham figure-eight coil will be used for stimulation. This sham coil will generate only clicking noise and will not generate any magnetic field. | Device | PD patients with sham rTMS |
| Transcranial magnetic stimulation- real rTMSTranscranial magnetic stimulation- figure-eight coil will be used for stimulation. 1 Hz stimulation, 100% of Resting Motor Threshold will be used. | Device | PD patients with real rTMS |
Primary outcome
Changes in score of the 3F Test (the unabbreviated title- "the 3F Test Dysarthric Profile")
Time frame: On the beginning of the study, after completion of two weeks stimulation, 4,8 and 12 weeks after completion of stimulation sessions.
The 3F Test Dysarthric Profile enables clinicians to characterize a wide range of signs and symptoms of dysarthria. The minimum value of this scale is 0 (anarthria), the maximum value is 90 (no disorder). Higher scores of this scale mean better outcome. This test will be administrated by speech pathologist.
1 secondary outcome
Resting state
Time frame: On the beginning of the study, after completion of two weeks stimulation, 4,8 and 12 weeks after completion of stimulation sessions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation- real rTMS in people with Parkinson Disease, run by Masaryk University at 1 site in Czechia.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 2 Sep 2020. 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in score of the 3F Test (the unabbreviated title- "the 3F Test Dysarthric Profile") (time frame: On the beginning of the study, after completion of two weeks stimulation, 4,8 and 12 weeks after completion of stimulation sessions.). 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 2 Sep 2020.