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

NCT04203615 | Completed

• 1 other identifier: NV16-30805A
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Resting state

  On the beginning of the study, after completion of two weeks stimulation, 4,8 and 12 weeks after completion of stimulation sessions.

Study Arms (2)

PD patients with real rTMS

ACTIVE COMPARATOR

Patients will receive real rTMS in a two weeks long sessions (10 sessions).

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).

Device: Transcranial magnetic stimulation- sham rTMS

Interventions

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.

PD patients with sham rTMS

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.

PD patients with real rTMS

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with clinically established PD (Postuma et al. 2016)

You may not qualify if:

• psychiatric disorders, including major depression, hallucinations
• any MRI-incompatible metal in the body
• epilepsy
• lack of cooperation
• presence of dementia

Sponsors & Collaborators

• Masaryk University: lead

Study Sites (1)

Central European Institute of Technology

Brno, Czechia

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 18, 2019
• Study Start: July 1, 2019
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-09

Locations

CZ (1)