Neuromodulation + Speech Therapy for Stuttering
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach to help adults who stutter by combining a special kind of brain stimulation (tDCS, using the Soterix Medical 1x1 tDCS system) with speech therapy. The goal is to determine if this combination can reduce the impact of stuttering on daily life and explore changes in brain activity. Participants will receive either real brain stimulation or a placebo version during speech therapy to compare results. This trial may suit adults diagnosed with developmental stuttering who experience mild to moderate symptoms. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for stuttering.
Will I have to stop taking my current medications?
If you are taking medications that affect brain activity, you may need to stop them to participate in this trial.
What prior data suggests that the Soterix Medical 1x1 tDCS system and speech therapy sessions are safe for adults who stutter?
Research has shown that transcranial direct current stimulation (tDCS) is generally safe. In previous studies, most users of the Soterix Medical 1x1 tDCS system experienced only minor side effects, such as slight tingling or itching at the application site. Serious side effects are rare, but following the operator's safety instructions is crucial.
The Soterix Medical 1x1 tDCS system is designed for accuracy and consistency, delivering the same level of electrical stimulation each time to help manage potential risks. While researchers continue to study tDCS as a treatment, its safety is supported by its use in various research settings.12345Why are researchers excited about this trial?
Researchers are excited about this treatment for stuttering because it combines neuromodulation with speech therapy in a way that's never been done before. Unlike traditional approaches that rely solely on speech therapy, this treatment uses a device called the Soterix Medical 1x1 tDCS system to deliver a gentle electrical current to the brain, potentially enhancing the effects of therapy. The active tDCS aims to modify brain activity patterns associated with stuttering, offering a new mechanism that could lead to more effective and faster results. By integrating these two methods, the treatment has the potential to improve speech fluency in ways that traditional therapy alone may not achieve.
What evidence suggests that this trial's treatments could be effective for stuttering?
This trial will compare the effects of combining transcranial direct current stimulation (tDCS) with speech therapy to speech therapy with sham tDCS. Research has shown that using a gentle electrical brain stimulation technique like tDCS alongside speech therapy might help reduce stuttering. One study found that combining tDCS with speech therapy improved language skills in people with speech difficulties. This occurs because tDCS can boost brain activity, helping different parts of the brain work together better for speech. Early findings suggest that this approach could enhance the effectiveness of speech therapy for those who stutter. While more research is needed, these initial results are promising for people considering this treatment.14678
Who Is on the Research Team?
Eric S. Jackson
Principal Investigator
NYU Langone Health
Are You a Good Fit for This Trial?
This trial is for adults who stutter and are looking to reduce the severity of their condition. Participants should be willing to undergo a non-invasive brain stimulation technique combined with speech therapy sessions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive transcranial direct current stimulation (tDCS) combined with behavioral speech therapy over ten sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Soterix Medical 1x1 tDCS system
- Speech therapy sessions
Trial Overview
The study tests if using the Soterix Medical 1x1 tDCS system, which delivers a low electrical current to the brain, along with traditional speech therapy can help improve stuttering in adults more than speech therapy alone.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor
Citations
NCT07222163 | Stuttering and Neuromodulation
The purpose of this study is to collect preliminary data on the efficacy of transcranial direct current stimulation (tDCS) combined with traditional ...
Soterix Medical Clinical Trials
The purpose of this study is to determine whether the effect of treatment for acquired speech impairment can be enhanced by combining effective behavioral ...
1x1 tDCS Device – Transcranial Direct Current Stimulation
The Soterix Medical 1x1 tDCS is the standard for precise and reproducible tDCS. Current intensity from 0.1 to 5 mA, and current duration from 5 to 40 minutes.
Neuromodulation + Speech Therapy for Stuttering
The purpose of this study is to collect preliminary data on the efficacy of transcranial direct current stimulation (tDCS) combined with traditional ...
PMC - PubMed Central
Recent studies suggest that combining transcranial direct current stimulation (tDCS) with SLT may improve language performance in persons with aphasia.
tDCS Overview – Transcranial Direct Current Stimulation
tDCS is an investigational technique, and it is the responsibility of the operator to identify and follow the most appropriate safety protocols. tDCS comfort ...
Transcranial electrical stimulation for clincal trials
The Soterix Medical 1x1-CT is the only tDCS stimulator allowing for both true double blind of experienced investigators and for simple operation by new users.
1x1 tDCS Tech Specs
Battery life (Fully charged batteries): 6 hrs ; Maximum Output Current: 5000 µA DC± 1% ; Maximum Output Voltage: 40V ± 5% ; Connector type: shielded banana.
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