Augmenting Treatment Effects of Voice Therapy in Parkinson Disease

September 21, 2020 updated by: James W. Wheless, Le Bonheur Children's Hospital
The purpose of this study is to evaluate the impact of a non-invasive brain stimulation technique called transcranial magnetic stimulation (TMS) on voice/speech treatment in people with Parkinson's Disease (PD), through the use of speech and voice analysis, examination of voice box, and brain imaging methods.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Effective treatment of the speech disorder in IPD is as important as the optimal control of limb motor symptoms. Presently, the Lee Silverman Voice Treatment (LSVTÒ LOUD) - is a time intensive behavioral treatment for Parkinson's hypophonia. Facilitatory TMS is a safe and a complimentary stimulation technique. Brain imaging has also identified suitable target brain regions that are readily accessible to TMS. This combined treatment modality approach should be more effective and efficient the LSVT alone.

The study will enroll patients with Parkinson's disease with moderate to severe hypophonia. A total of 36 patients will be recruited over 3 years and divided into 3 groups (n=12 each). The three cohorts are: 1. LSVT +sham TMS; 2. LSVT +left rTMS and 3. LSVT + right rTMS.

This is a longitudinal double blind randomized controlled clinical trial. All investigators and study personnel will be blind to the study except for the PI responsible for TMS (Dr. Narayana). The entire protocol occurs over 19 weeks. During the first week, the participants will be screened, consented. During the second week, baseline behavioral and imaging data will be collected. Next, the patients will be randomized to one of the three treatment groups. Then the patients will enter a 4-week treatment phase, where they will receive TMS/sham TMS and LSVT 4 days a week for 4 weeks. During the seventh week, patients will undergo post treatment behavioral and imaging assessments. Then the patients will return in week 19 to complete the follow up behavioral measures and imaging session.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • LeBonheur Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals with Idiopathic Parkinson's disease (IPD) between the ages of 45 and 80 years with moderate to severe hypophonia
  • None or mild cognitive impairment or depression
  • Stable medication therapy for at least 3 months. Must be "optimally medicated" at the start of the study. This means that there should be no change in mediction type or dosage in 3 months prior to enrolling in the study. The medications should not be causing significant or serious advese effects

Exclusion Criteria:

  • History of drug abuse or neurological condition other than or in addition to IPD (for example stroke)
  • Individuals with advanced IPD (stage V) or who had LSVT within 3 years
  • Pregnant females
  • History of seizures, history of major head trauma, metal objects implanted in the head, ferrous metal filings in the eye, brain damage, inflammation of the brain, cardiac pacemaker, implanted medication pump, cardiac lines, heart disease, currently taking certain types of medication for depression or seizures (tricyclic antidepressants or neuroleptics which lower seizure threshold

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: LSVT +sham TMS
Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS)
Behavioral: Lee Silverman Voice Treatment
Time intensive behavioral treatment for Parkinson's hypophonia
Other Names:
  • LSVT
Active Comparator: LSVT +left rTMS
Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS) applied to left side of head
Behavioral: Lee Silverman Voice Treatment
Time intensive behavioral treatment for Parkinson's hypophonia
Other Names:
  • LSVT
Other: Transcranial Magnetic Stimulation
Treament adjuvant applied to accelerate vocal motor learning and overall voice improvement
Other Names:
  • TMS
Active Comparator: LSVT + right rTMS
Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS) applied to right side of brain
Behavioral: Lee Silverman Voice Treatment
Time intensive behavioral treatment for Parkinson's hypophonia
Other Names:
  • LSVT
Other: Transcranial Magnetic Stimulation
Treament adjuvant applied to accelerate vocal motor learning and overall voice improvement
Other Names:
  • TMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical assessment:
Time Frame: 19 weeks
Voice intensity and overall voice quality
19 weeks
Patient assessment:
Time Frame: 19 weeks
10-item Voice related Quality of Life Scale (V-RQOL)
19 weeks
Physiological assessment:
Time Frame: 19 weeks
Vocal fold function; Changes in brain activation: at the site of TMS stimulation and the speech motor network; and Functional connectivity within the speech motor network
19 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical assessment
Time Frame: 19 weeks
intelligibility and articulation
19 weeks
Patient self-assessment
Time Frame: 19 weeks
visual analog scaling of speech intelligibility
19 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Le Bonheur Children's Hospital

Collaborators

University of Tennessee
Michael J. Fox Foundation for Parkinson's Research
University of Memphis

Investigators

  • Principal Investigator: Shalini Narayana, PhD, LeBonheur Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

October 14, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Actual)

September 22, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-03265-FB UM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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