NCT02265315

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

6.3 years

First QC Date

October 9, 2014

Last Update Submit

September 21, 2020

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

  • Clinical assessment:

    Voice intensity and overall voice quality

    19 weeks

  • Patient assessment:

    10-item Voice related Quality of Life Scale (V-RQOL)

    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

    19 weeks

Secondary Outcomes (2)

  • Clinical assessment

    19 weeks

  • Patient self-assessment

    19 weeks

Study Arms (3)

LSVT +sham TMS

SHAM COMPARATOR

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

Behavioral: Lee Silverman Voice Treatment

LSVT +left rTMS

ACTIVE COMPARATOR

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

Other: Transcranial Magnetic StimulationBehavioral: Lee Silverman Voice Treatment

LSVT + right rTMS

ACTIVE COMPARATOR

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

Other: Transcranial Magnetic StimulationBehavioral: Lee Silverman Voice Treatment

Interventions

Transcranial Magnetic StimulationOTHER

Treament adjuvant applied to accelerate vocal motor learning and overall voice improvement

Also known as: TMS
LSVT + right rTMSLSVT +left rTMS
Lee Silverman Voice TreatmentBEHAVIORAL

Time intensive behavioral treatment for Parkinson's hypophonia

Also known as: LSVT
LSVT + right rTMSLSVT +left rTMSLSVT +sham TMS

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LeBonheur Children Hospital

Memphis, Tennessee, 38103, United States

Location

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Shalini Narayana, PhD

    LeBonheur Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shalini Narayana, Ph.D.

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 15, 2014

Study Start

October 1, 2014

Primary Completion

December 31, 2020

Study Completion

June 30, 2021

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Locations

US(1)