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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-01-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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PD patients with real rTMS

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

Group Type ACTIVE_COMPARATOR

Transcranial magnetic stimulation- real rTMS

Intervention Type 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 sham rTMS

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

Group Type SHAM_COMPARATOR

Transcranial magnetic stimulation- sham rTMS

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No