Neurostimulation to improve speech after a stroke
Neurostimulation for the Treatment of Post-Stroke Aphasia
NA · QVITI S.A. · NCT05194566
This study is testing if a new brain stimulation technique combined with speech therapy can help people who have trouble speaking after a stroke.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | QVITI S.A. (industry) |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05194566 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of 75Hz transcranial alternating current stimulation (tACS) combined with therapeutic linguistic tasks for individuals suffering from post-stroke aphasia. The study aims to enhance speech-language processing by applying brain stimulation to the motor cortex, potentially improving communication abilities in patients. Participants will undergo assessments to determine their eligibility based on their aphasia severity and other criteria. The goal is to develop a more effective rehabilitation protocol for those affected by this challenging condition.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-80 with chronic post-stroke aphasia and a specific level of naming task accuracy.
Not a fit: Patients with severe cognitive, auditory, or visual impairments that hinder language testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve communication abilities in patients with post-stroke aphasia.
How similar studies have performed: Previous studies have shown mixed results with similar brain stimulation approaches, indicating a need for further investigation into the efficacy of tACS.
Eligibility criteria
Show full inclusion / exclusion criteria
Individuals with aphasia (assessed using the Boston Diagnostic Aphasia Examination) who perform the Naming Task in the range of 10%-60% accuracy will be included in the study. The overall baseline score in the Naming Task will be estimated from the two baseline measurements. Inclusion Criteria: * diagnosis of aphasia: Broca's or mixed (based on the assessment of a Speech Language Pathologist). * presence of a focus of injury in the left hemisphere (within one hemisphere only) as a result of the first ischemic or hemorrhagic stroke (based on CT/MRI examination); * chronic stage of the disease - time since the stroke occurred over 6 months. * ability to achieve an accuracy in the Naming Task of 10-60%. * 18-80 years * right-handedness before the stroke. * ability to give informed written consent. * fluency in English. Exclusion Criteria: * severe cognitive, auditory or visual impairment that would preclude cognitive and language testing - inability to follow a two-step command. * presence of metal implants in the skull. * presence of major untreated or unstable psychiatric disease. * history of epilepsy or seizures. * ongoing medication that increases the risk of epileptic seizures. * presence in the body of cardiac stimulator, pacemaker or vagus nerve stimulator (implanted). * history of speech, language, hearing, or intellectual disability during childhood. * pregnancy (based on declarations) Exclusion criteria during the trial: * high intolerance to stimulation. * occurrence of an epileptic seizure. * other previously absent neurological or mental symptoms Withdrawal criteria: * high intolerance to stimulation (participants experience severe discomfort during stimulation); * occurrence of an epileptic seizure; * other previously absent neurological, physical or mental symptoms.
Where this trial is running
Chicago, Illinois and 1 other locations
- Think & Speak Lab at Shirley Ryan AbilityLab — Chicago, Illinois, United States (RECRUITING)
- Abilities Research Center at Mount Sinai — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Miguel Escalon, MD, MPH — Icahn School of Medicine at Mount Sinai
- Study coordinator: Tertia Jeppson
- Email: tjeppson@sralab.org
- Phone: 312-238-6163
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post-stroke Aphasia, speech therapy, brain stimulation, communication, language