An interventional study of Transcranial Magnetic Stimulation and Lee Silverman Voice Treatment in Parkinson Disease, sponsored by Le Bonheur Children's Hospital. Status unknown at 1 site in United States. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-09-22.
Sponsored by Le Bonheur Children's Hospital · Not applicable, Interventional, and Treatment
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.
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 70 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Le Bonheur Children's Hospital is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS)
Behavioral: Lee Silverman Voice Treatment
Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS) applied to left side of head
Other: Transcranial Magnetic Stimulation · Behavioral: Lee Silverman Voice Treatment
Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS) applied to right side of brain
Other: Transcranial Magnetic Stimulation · Behavioral: Lee Silverman Voice Treatment
Treament adjuvant applied to accelerate vocal motor learning and overall voice improvement
Also known as: TMS
Time intensive behavioral treatment for Parkinson's hypophonia
Also known as: LSVT
Clinical assessment:
Voice intensity and overall voice quality
Time frame: 19 weeks
Patient assessment:
10-item Voice related Quality of Life Scale (V-RQOL)
Time frame: 19 weeks
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
Time frame: 19 weeks
Clinical assessment
intelligibility and articulation
Time frame: 19 weeks
Patient self-assessment
visual analog scaling of speech intelligibility
Time frame: 19 weeks
Plan to share: Yes
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Le Bonheur Children's Hospital