Stuttering and Neuromodulation

Browse trials for

• Stuttering 74

Keywords

• tDCS

Stuttering

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

This study's planned enrollment of 16 is below the median of 44 across 57 interventional studies indexed under Stuttering.

Lead sponsor

NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.

Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.

Study arms

• Experimental
  Behavioral speech therapy combined with active tDCS

  Each participant will complete ten treatment sessions over approximately ten weeks. In each session, participants will receive active tDCS for 30 minutes while concurrently engaging in behavioral speech therapy. Active stimulation will include a 30-second ramp-up to 2.0 mA, 30 minutes of continuous stimulation, and a 30-second ramp-down.

  Device: Soterix Medical 1x1 tDCS system · Behavioral: Speech therapy sessions

• Sham comparator
  Behavioral speech therapy combined with sham tDCS

  Each participant will complete ten treatment sessions over approximately ten weeks. In each session, participants will receive sham tDCS for 30 minutes while concurrently engaging in behavioral speech therapy. Sham stimulation will involve the same ramp-up and ramp-down but with no current delivered during the 30-minute period to maintain blinding.

  Device: Soterix Medical 1x1 tDCS system · Behavioral: Speech therapy sessions

Interventions

• DeviceSoterix Medical 1x1 tDCS system

  Stimulation (2.0 mA for 30 minutes) will occur during speech therapy sessions focused on practicing speech techniques. Sham stimulation will mimic the physical sensation without active current.

• BehavioralSpeech therapy sessions

  Each of the ten weekly sessions will begin with 15 minutes of strategy practice, providing participants with the opportunity to rehearse light contact and easy onset techniques prior to the tDCS-enhanced speaking task.

Primary outcomes

1. Change in Stuttering Severity Instrument - 4th Edition (SSI-4) total score

   The Stuttering Severity Instrument-4th Edition (SSI-4) provides a total score that is compared to age-specific norms to determine severity, with ranges for "Very Mild" to "Very Severe". The SSI-4 calculates individual scores for frequency (2-18), duration (2-18), and physical concomitants (0-20). These individual scores are combined to create a total score, which is then ranked against norms to provide a verbal severity descriptor, such as mild, moderate, severe, or very severe.

   Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)

2. Change in the Wright and Ayre Stuttering Self-Rating Profile (WASSP) score

   The WASSP produces a profile of scores across five subscales. There is a total of 26 items each scored on a seven-point Likert-type scale. A score of '1' represents the least severe/negative perception, while a '7' represents the most severe/negative perception on each scale. Total scores range from 26-182, with higher scores indicating a greater negative impact of stuttering on their life.

   Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)

3. Stuttering impact as assessed by the Overall Assessment of the Speaker's Experience of Stuttering - Adults (OASES-A)

   The OASES-A is a tool used by speech-language pathologists to measure the adverse impact of stuttering on an adult's life. It consists of 100 questions rated on a 5-point scale (1-5). The scores from individual questions are added together to create an overall score. The total score is then used to determine the "Impact Rating" on a scale from mild to severe. Higher scores indicate higher levels of negative impact.

   Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)

4. Change in the Brief Version of the Unhelpful Thoughts and Beliefs About Stuttering Scales (UTBAS-6) total score

   The UTBAS-6 is a six-item screening questionnaire for adults who stutter to measure unhelpful thoughts and beliefs associated with speech anxiety. The UTBAS-6 has a subscale score range of 6 to 30 and a total score range of 18 to 90. A higher score indicates more frequent unhelpful thoughts and greater anxiety related to stuttering.

   Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)

5. Change in Brief Fear of Negative Evaluation (BFNE-S) Scale total score

   The BFNE-S consists of 8 items that are rated on a five-point likert scale from 1 (not at all characteristic) to 4 (extremely characteristic). Scores range from 0 to 32. A score of 25 or higher may indicate clinically significant social anxiety.

   Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)

6. Social Interaction Anxiety Scale (SIAS)

   The SIAS is a 20-item self-report questionnaire that measures the severity of social anxiety. Each item is rated from 0 (not at all characteristic or true of me) to 4 (extremely characteristic or ture of me). Scores can range from 0 (no social anxiety) to 80 (maximum social anxiety). A score of 36 or higher is often considered clinically significant, suggesting the presence of social anxiety.

   Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)

Secondary outcomes

1. Change in regional activation in/between cognitive control and speech motor areas during a delayed-naming task

   Neuroplastic changes will be assessed using functional near-infrared spectroscopy (fNIRS) to measure cortical activation patterns (i.e., regional activation, functional connectivity) in/between cognitive control and speech motor areas during a delayed-naming task (pre- and post-intervention).

   Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)

2. Change in functional connectivity in/between cognitive control and speech motor areas during a delayed-naming task

   Neuroplastic changes will be assessed using functional near-infrared spectroscopy (fNIRS) to measure cortical activation patterns (i.e., regional activation, functional connectivity) in/between cognitive control and speech motor areas during a delayed-naming task (pre- and post-intervention).

   Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)

Individual participant data

Plan to share: Yes — The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting researcher provide a methodologically sound proposal and executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Ej34@nyu.edu. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

Access criteria: Researchers who provide a methodologically sound proposal will be granted access upon reasonable request. Requests should be directed to Ej34@nyu.edu. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.