Effect of Noninvasive Brain Stimulation on Hypokinetic Dysarthria in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Effect of Noninvasive Brain Stimulation on Hypokinetic Dysarthria and Brain Plasticity in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203615
• Other study ID #: NV16-30805A
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: September 2020
• Source: Masaryk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysarthria
• Parkinson Disease

Intervention

Device:
• Transcranial magnetic stimulation- sham rTMS
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 rTMS
Transcranial magnetic stimulation- figure-eight coil will be used for stimulation. 1 Hz stimulation, 100% of Resting Motor Threshold will be used.

Locations

Country	Name	City	State
Czechia	Central European Institute of Technology	Brno

Sponsors (1)

Lead Sponsor	Collaborator
Masaryk University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	On the beginning of the study, after completion of two weeks stimulation, 4,8 and 12 weeks after completion of stimulation sessions.
Secondary	Resting state	The effect of stimulation on the resting state networks will be studied using fMRI measurement.	On the beginning of the study, after completion of two weeks stimulation, 4,8 and 12 weeks after completion of stimulation sessions.