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Augmenting Treatment Effects of Voice Therapy in Parkinson Disease

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Lee Silverman Voice Treatment
Sponsored by
Le Bonheur Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LeBonheur Children Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

LSVT +sham TMS

LSVT +left rTMS

LSVT + right rTMS

Arm Description

Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS)

Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS) applied to left side of head

Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS) applied to right side of brain

Outcomes

Primary Outcome Measures

Clinical assessment:
Voice intensity and overall voice quality
Patient assessment:
10-item Voice related Quality of Life Scale (V-RQOL)
Physiological assessment:
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

Secondary Outcome Measures

Clinical assessment
intelligibility and articulation
Patient self-assessment
visual analog scaling of speech intelligibility

Full Information

First Posted
October 9, 2014
Last Updated
September 21, 2020
Sponsor
Le Bonheur Children's Hospital
Collaborators
Michael J. Fox Foundation for Parkinson's Research, University of Tennessee, University of Memphis
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1. Study Identification

Unique Protocol Identification Number
NCT02265315
Brief Title
Augmenting Treatment Effects of Voice Therapy in Parkinson Disease
Official Title
Augmenting Treatment Effects of Voice Therapy in Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Le Bonheur Children's Hospital
Collaborators
Michael J. Fox Foundation for Parkinson's Research, University of Tennessee, University of Memphis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LSVT +sham TMS
Arm Type
Sham Comparator
Arm Description
Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS)
Arm Title
LSVT +left rTMS
Arm Type
Active Comparator
Arm Description
Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS) applied to left side of head
Arm Title
LSVT + right rTMS
Arm Type
Active Comparator
Arm Description
Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS) applied to right side of brain
Intervention Type
Other
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
TMS
Intervention Description
Treament adjuvant applied to accelerate vocal motor learning and overall voice improvement
Intervention Type
Behavioral
Intervention Name(s)
Lee Silverman Voice Treatment
Other Intervention Name(s)
LSVT
Intervention Description
Time intensive behavioral treatment for Parkinson's hypophonia
Primary Outcome Measure Information:
Title
Clinical assessment:
Description
Voice intensity and overall voice quality
Time Frame
19 weeks
Title
Patient assessment:
Description
10-item Voice related Quality of Life Scale (V-RQOL)
Time Frame
19 weeks
Title
Physiological assessment:
Description
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
Time Frame
19 weeks
Secondary Outcome Measure Information:
Title
Clinical assessment
Description
intelligibility and articulation
Time Frame
19 weeks
Title
Patient self-assessment
Description
visual analog scaling of speech intelligibility
Time Frame
19 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shalini Narayana, PhD
Organizational Affiliation
LeBonheur Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
LeBonheur Children Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Links:
URL
https://foxtrialfinder.michaeljfox.org/trial/3885/
Description
Michael J. Fox Trial Finder

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Augmenting Treatment Effects of Voice Therapy in Parkinson Disease

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