Augmenting Treatment Effects of Voice Therapy in Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

Augmenting Treatment Effects of Voice Therapy in Parkinson Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02265315
• Other study ID #: 14-03265-FB UM
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2014
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2020
• Source: Le Bonheur Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Transcranial Magnetic Stimulation
Treament adjuvant applied to accelerate vocal motor learning and overall voice improvement

Behavioral:
• Lee Silverman Voice Treatment
Time intensive behavioral treatment for Parkinson's hypophonia

Locations

Country	Name	City	State
United States	LeBonheur Children Hospital	Memphis	Tennessee

Sponsors (4)

Lead Sponsor	Collaborator
Le Bonheur Children's Hospital	Michael J. Fox Foundation for Parkinson's Research, University of Memphis, University of Tennessee Health Science Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical assessment:	Voice intensity and overall voice quality	19 weeks
Primary	Patient assessment:	10-item Voice related Quality of Life Scale (V-RQOL)	19 weeks
Primary	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	19 weeks
Secondary	Clinical assessment	intelligibility and articulation	19 weeks
Secondary	Patient self-assessment	visual analog scaling of speech intelligibility	19 weeks

External Links

•   Michael J. Fox Trial Finder