Effect of Noninvasive Brain Stimulation on Hypokinetic Dysarthria in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Transcranial magnetic stimulation- sham rTMS
Transcranial magnetic stimulation- real rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- patients with clinically established PD (Postuma et al. 2016)
Exclusion Criteria:
- psychiatric disorders, including major depression, hallucinations
- any MRI-incompatible metal in the body
- epilepsy
- lack of cooperation
- presence of dementia
Sites / Locations
- Central European Institute of Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
PD patients with real rTMS
PD patients with sham rTMS
Arm Description
Patients will receive real rTMS in a two weeks long sessions (10 sessions).
Patients will receive sham rTMS in a two weeks long sessions (10 sessions).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Resting state
The effect of stimulation on the resting state networks will be studied using fMRI measurement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04203615
Brief Title
Effect of Noninvasive Brain Stimulation on Hypokinetic Dysarthria in Parkinson's Disease
Official Title
Effect of Noninvasive Brain Stimulation on Hypokinetic Dysarthria and Brain Plasticity in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masaryk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PD patients with real rTMS
Arm Type
Active Comparator
Arm Description
Patients will receive real rTMS in a two weeks long sessions (10 sessions).
Arm Title
PD patients with sham rTMS
Arm Type
Sham Comparator
Arm Description
Patients will receive sham rTMS in a two weeks long sessions (10 sessions).
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation- sham rTMS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation- real rTMS
Intervention Description
Transcranial magnetic stimulation- figure-eight coil will be used for stimulation. 1 Hz stimulation, 100% of Resting Motor Threshold will be used.
Primary Outcome Measure Information:
Title
Changes in score of the 3F Test (the unabbreviated title- "the 3F Test Dysarthric Profile")
Description
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.
Time Frame
On the beginning of the study, after completion of two weeks stimulation, 4,8 and 12 weeks after completion of stimulation sessions.
Secondary Outcome Measure Information:
Title
Resting state
Description
The effect of stimulation on the resting state networks will be studied using fMRI measurement.
Time Frame
On the beginning of the study, after completion of two weeks stimulation, 4,8 and 12 weeks after completion of stimulation sessions.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with clinically established PD (Postuma et al. 2016)
Exclusion Criteria:
psychiatric disorders, including major depression, hallucinations
any MRI-incompatible metal in the body
epilepsy
lack of cooperation
presence of dementia
Facility Information:
Facility Name
Central European Institute of Technology
City
Brno
Country
Czechia
12. IPD Sharing Statement
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Effect of Noninvasive Brain Stimulation on Hypokinetic Dysarthria in Parkinson's Disease
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