NCT00071734

Brief Summary

This study will examine the central regions and brain activation patterns associated with simple vocal behaviors under conditions of normal auditory feedback-when people hear themselves speak. Such feedback plays a major role in learning and maintaining human voice control. But voice control can be harmed by neurological injury or disease, reducing the ability of a person to orally communicate. Research has shown that auditory feedback is continuously monitored, brought about by both automatic and voluntary corrections in the amplitude (loudness) and frequency of (pitch) of the human voice. This study aims to determine which areas of the brain have activity dependent on the level of blood oxygen. It will provide new knowledge about basic vocal motor control and provide a basis for investigations into the integration of hearing and speaking in human vocal expression throughout life. Participants 18 to 45 years of age with normal hearing and voice function and with a steady heart rate may be eligible for this study. Participants will be evaluated by a speech-language specialist, regarding a history of voice health and measures of voice function. They will be tested on their ability to vary voice amplitude and frequency and tested on their hearing. Also, they will undergo an electrocardiogram to determine their heart rate. For the study, participants will undergo an MRI scan. During the MRI scan, patients will lie still on a table that can slide in and out of a metal cylinder surrounded by a strong magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans between 45 and 90 minutes. Patients may be asked to lie still for up to 90 minutes at a time. As the scanner takes pictures, there will be loud knocking noises, and patients will wear headphones to muffle the sound. The headphones will also enable patients to hear their voice. The patient's head will be positioned with a coil of 25 to 30 cm diameter and supported by a headrest. A microphone will be placed about 2 cm from the patient's mouth for communication and collection of data. Also, an angled mirror will be attached to the head coil, so that the patient can look outside of the scanner. By way of a projection screen, the patient will receive a visual cue to vocalize, or use his or her voice. Patients will be asked to repeatedly do some of the following vocalization tasks: (1) rest, (2) hum or sigh without voicing (exhale), (3) hum or sigh audibly, (4) hum audibly while increasing or decreasing voice frequency, and (5) hum audibly while increasing or decreasing voice amplitude. During the scan, patients will be able to communicate with the MRI staff at all times and may ask to be moved out of the machine at any time. Some scans may be done in a 3 Tesla scanner. It is the latest advance in MRI, with a stronger magnetic field than in the more common 1.5 Tesla scanner. Functional MRI is done while a person is performing tasks, such as moving a limb or speaking. The fMRI scan will take about 1 hour.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2003

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2003

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2003

Completed
Same day until next milestone

First Posted

Study publicly available on registry

October 29, 2003

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

October 1, 2004

First QC Date

October 29, 2003

Last Update Submit

March 3, 2008

Conditions

Keywords

fMRIAuditory FeedbackMotor ControlAdultBOLDHealthy VolunteerHV

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females of any race or ethnicity will be eligible to participate in this study.
  • Volunteers must be between the ages of 18 and 45 with normal hearing and voice function. Participants will be further selected for having a steady heart rate. A history of voice training is not required, but participants must be able to produce grossly independent voice F0 and amplitude changes.

You may not qualify if:

  • Contraindications to participation include: pregnancy, cardiac pacemaker or auto defibrillator, artificial heart valve, neural pacemaker, surgical metal clips in the brain, eye, or on blood vessels, cochlear implants, ocular implants or foreign bodies such as metal shavings or splinters, insulin pump, implanted drug infusion device, shrapnel, bullet or shot wound, and tattooed makeup. Participants will be screened with the NMR Center Safety Screening Questionnaire which also includes items such as intraventricular shunts, transdermal medication patches, wire sutures, bone/joint pins, screws, nails, or plates, and body piercings. Given that surgical staples, orthopedic pins, orthodontic braces and dental implants are no longer considered absolute contraindications in MRI, Dr. Saxon or Dr. Kearney will approve or disapprove participation in the study based on their judgment of the MR compatibility of these items, using published guides including those referenced above.
  • Volunteers will be also excluded if they are found to be pregnant, report any tendency toward claustrophobia or are unable for any reason to lie still within an MR scanner.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Simonyan K, Jurgens U. Cortico-cortical projections of the motorcortical larynx area in the rhesus monkey. Brain Res. 2002 Sep 13;949(1-2):23-31. doi: 10.1016/s0006-8993(02)02960-8.

    PMID: 12213296BACKGROUND
  • Gunji A, Hoshiyama M, Kakigi R. Identification of auditory evoked potentials of one's own voice. Clin Neurophysiol. 2000 Feb;111(2):214-9. doi: 10.1016/s1388-2457(99)00235-7.

    PMID: 10680556BACKGROUND
  • Curio G, Neuloh G, Numminen J, Jousmaki V, Hari R. Speaking modifies voice-evoked activity in the human auditory cortex. Hum Brain Mapp. 2000 Apr;9(4):183-91. doi: 10.1002/(sici)1097-0193(200004)9:43.0.co;2-z.

    PMID: 10770228BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

October 29, 2003

First Posted

October 29, 2003

Study Start

October 1, 2003

Study Completion

October 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-10

Locations