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NCT Number: NCT04203615

Effect of Noninvasive Brain Stimulation on Hypokinetic Dysarthria 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central European Institute of Technology

Brno, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial magnetic stimulation- sham rTMS

Device

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

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    The effect of stimulation on the resting state networks will be studied using fMRI measurement.

Sponsors and collaborators

Lead sponsor

Masaryk University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 18, 2019
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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