Using Non-invasive Brain Stimulation to Explore Potential Treatments to Reduce Speech Errors in Adults Who Stutter

Browse trials for

• Stuttering 74
• Speech 205

Keywords

• Stuttering
• HD-tDCS
• neuromodulation
• speech
• fluency

Stuttering

74 studies on the registry are indexed under Stuttering; 23 are open to participants now.

This study's planned enrollment of 50 is above the median of 44 across 57 interventional studies indexed under Stuttering.

Lead sponsor

The University of Texas at Dallas is the lead sponsor of 60 studies on the registry; 19 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.

Study arms

• Experimental
  Left Inferior Frontal Gyrus

  This arm is designed to analyze if treatment on the speech production area of the brain (also known as Broca's area) will decrease speech errors and increase ease of production in people who stutter

  Device: High - Definition Transcranial Direct Current Stimulation

• Experimental
  Presupplementary motor area

  This arm is designed to investigate whether treatment targeting the motor planning region of the brain can reduce speech errors and increase ease of production in individuals who stutter.

  Device: High - Definition Transcranial Direct Current Stimulation

Interventions

• DeviceHigh - Definition Transcranial Direct Current Stimulation

  HD-tDCS protocol for LIFG group is as follows: A single 20-minute session with one anode at F7 at 1 mA and four 0.25 mA cathodes at T7, FP1, AF3, FC5 at 0.25 mA HD-tDCS protocol for the Pre-SMA group is as follows: A single 20-minute session with one anode 1mA at Fz 1 mA and four 0.25 mA cathodes at FP1, FP2, F7, F8

  Also known as: Neuroelectrics, Starstim, HD-tDCS, Non-invasive brain stimulation, neuromodulation

Primary outcomes

1. Stuttering Severity Instrument - 4

   Stuttering Severity Instrument-Fourth Edition (SSI-4) is a reliable and valid norm-referenced stuttering assessment that can be used for both clinical and research purposes. It measures stuttering severity in both children and adults in the four areas of speech behavior: frequency duration physical concomitants naturalness of the individual's speech. The SSI-4 scores stuttering severity by combining measures of frequency (% syllables stuttered), duration (length of longest stutters), and physical concomitants (secondary behaviors) into a total score, which is then converted to a percentile rank and severity level (very mild to very severe) using age-specific standards. Higher percentile scores indicate more severe stuttering, with ranges like 1-4% being very mild and 96-99% very severe.

   Time frame: Measured at singular clinical visit (baseline)

2. Predictive Naming Task

   Participants are instructed to name images on a screen, given phrases that indicate high or low predictability for the target word. Task is measured by accuracy (number of correct answers) and participant response time.

   Time frame: Measured at singular clinical visit (baseline)

Secondary outcomes

1. Overall Assessment of the Speaker's Experience of Stuttering

   The Overall Assessment of the Speaker's Experience of Stuttering (OASES) gives clinicians and researchers an impact rating and impact score, which reflect the degree of adverse impact a speaker experiences due to stuttering. The impact score combines information about (a) the speaker's perceptions about stuttering; (b) the negative affective (feelings), behavioral (actions), and cognitive (thoughts) reactions that the speaker has to stuttering; (c) the functional communication difficulties a speaker may have in different speaking environments; and (d) the impact of stuttering on the speaker's overall quality of life. The OASES is the only published tool that specifically examines Quality of Life in people who stutter. The OASES score reflects the impact of stuttering on a person's life, using a 1-5 rating scale where higher scores indicate a more severe impact, categorized into mild, mild-to-moderate, moderate, moderate-to-severe, and severe levels.

   Time frame: Completed during enrollment process (24 hours pre-visit during consent)

2. Button push Go/NoGo task

   Participants are instructed to press a button when category A (objects) is presented on the screen, but not to push when category B (animals) is shown. Task is measured by accuracy (number of correct answers) and participant response time.

   Time frame: Measured at singular clinical visit (baseline)

Individual participant data

Plan to share: Yes — De-identified data and clinical study report will be available for the public

Supporting information: Clinical study report

Time frame: IPD data will be available 3 months after publication

Access criteria: The Clinical Study Report (CSR) will be made available upon reasonable request. Researchers must submit a brief written request describing the purpose of accessing the CSR. Requests will be reviewed by the study team for appropriateness and compliance with institutional policies.