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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: Transcranial magnetic stimulation- real rTMS; Device: Transcranial magnetic stimulation- sham rTMS

• Registration Number: NCT04203615
• Lead Sponsor: Masaryk University

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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-18
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PD patients with real rTMS	Transcranial magnetic stimulation- real rTMS	Patients will receive real rTMS in a two weeks long sessions (10 sessions).
PD patients with sham rTMS	Transcranial magnetic stimulation- sham rTMS	Patients will receive sham rTMS in a two weeks long sessions (10 sessions).

Primary Outcome Measures

Name	Time	Method
Changes in score of the 3F Test (the unabbreviated title- "the 3F Test Dysarthric Profile")	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.

Secondary Outcome Measures

Name	Time	Method
Resting state	On the beginning of the study, after completion of two weeks stimulation, 4,8 and 12 weeks after completion of stimulation sessions.	The effect of stimulation on the resting state networks will be studied using fMRI measurement.

Trial Locations

Locations (1)

Central European Institute of Technology; 🇨🇿 Brno, Czechia