Augmenting Treatment Effects of Voice Therapy in Parkinson Disease
NCT ID: NCT02265315
Last Updated: 2020-09-22
Study Results
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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UNKNOWN
NA
70 participants
INTERVENTIONAL
2014-10-31
2021-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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LSVT +sham TMS
Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS)
Lee Silverman Voice Treatment
Time intensive behavioral treatment for Parkinson's hypophonia
LSVT +left rTMS
Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS) applied to left side of head
Transcranial Magnetic Stimulation
Treament adjuvant applied to accelerate vocal motor learning and overall voice improvement
Lee Silverman Voice Treatment
Time intensive behavioral treatment for Parkinson's hypophonia
LSVT + right rTMS
Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS) applied to right side of brain
Transcranial Magnetic Stimulation
Treament adjuvant applied to accelerate vocal motor learning and overall voice improvement
Lee Silverman Voice Treatment
Time intensive behavioral treatment for Parkinson's hypophonia
Interventions
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Transcranial Magnetic Stimulation
Treament adjuvant applied to accelerate vocal motor learning and overall voice improvement
Lee Silverman Voice Treatment
Time intensive behavioral treatment for Parkinson's hypophonia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
80 Years
ALL
No
Sponsors
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Michael J. Fox Foundation for Parkinson's Research
OTHER
University of Tennessee
OTHER
University of Memphis
OTHER
Le Bonheur Children's Hospital
OTHER
Responsible Party
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James W. Wheless
Shalini Narayana, Ph.D.
Principal Investigators
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Shalini Narayana, PhD
Role: PRINCIPAL_INVESTIGATOR
LeBonheur Children's Hospital
Locations
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LeBonheur Children Hospital
Memphis, Tennessee, United States
Countries
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Related Links
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Michael J. Fox Trial Finder
Other Identifiers
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14-03265-FB UM
Identifier Type: -
Identifier Source: org_study_id
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