Clinical Research Directory

Neural Bases of Vocal Sensorimotor Impairment in Aphasia

Aphasia is the most common type of post-stroke communication disorder characterized by deficits in speech comprehension, production and control. While recovery can be promoted with speech therapy, improvement remains modest and typically requires a large number of sessions contributing to rising health care costs. Traditional aphasia therapy focus on enhancing speech motor output; however, recent evidence suggests that the auditory feedback also plays a critical role in fluent speech. Therefore, a key step toward refining treatment strategies is to develop objective biomarkers that can probe the integrity of sensorimotor mechanisms of speech auditory feedback and identify their impaired function in patients with post-stroke aphasia. This study aims to examine the behavioral, neurophysiological (EEG), and neuroimaging (fMRI) biomarkers of speech impairment following stroke with focus on understanding the role of auditory feedback for speech production and control. We plan to test individuals with post-stroke aphasia and a matched neuroptypical control group during different speech production tasks under the altered auditory feedback paradigm. In addition, we aim to examine the effect of audio-visual feedback training on enhancing communication ability during speech. These biomarkers will be combined with existing lesion-symptom-mapping data in the aphasic group in order to identify the patterns of brain damage and diminished structural connectivity within the auditory-motor areas of the left hemisphere that predict impaired sensorimotor processing of speech in aphasia. The long-term goal of this research is to develop a model for identifying the source of sensorimotor deficit and improve diagnosis and targeted treatment of speech disorders in aphasia.

Recovery From Post-Stroke Aphasia With rTMS Targeting Left or Right Anterior Temporal Lobe

This project aims to tailor repetitive Transcranial Magnetic Stimulation (rTMS) target to the clinical profile of post-stroke aphasia, specifically focusing on lexicosemantic impairments, to enhance recovery. Functional Magnetic Resonance Imaging (fMRI) will provide critical insights into the effects of facilitatory versus inhibitory stimulation on interhemispheric balance. Additionally, this study will generate new data on how lesion localization and brain connectivity influence individual responses to rTMS, explaining variability in treatment efficacy.

Targeted TDCS to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia.

62 patients who are one year post stroke and have Aphasia as a result of that stroke will be recruited. Participants will have 4 assessment sessions and 15 treatment sessions. The TDCS will be to right Inferior Frontal Gyrus (IFG) (25 active, 25 sham) for 15 days. A combined semantic feature analysis/phonological components analysis treatment will be paired with the stimulation. Two assessment sessions will be pretreatment, 1 session immediately post-treatment, and 1 session at 3 months follow-up.

LEXURE for Post-Stroke Aphasia

This study evaluates the efficacy of digital language rehabilitation using LEXURE for the treatment of post-stroke aphasia. Half of participants will receive structured language training using the LEXURE application, while the other half will receive workbook-based language training as an active comparator.

First Responder Aphasia Strategy Training

This study aims to determine the impact of a collaborative approach to training law enforcement officers and first responders about aphasia including their knowledge and confidence in communicating with individuals with aphasia that they may encounter in the field. 75 participants from Madison Police Department will be enrolled and can expect to be on study for up to 6 months.

Enhancing Reading Recovery in Aphasia With tDCS and Phonomotor Therapy

This study is designed for individuals with aphasia, a language disorder that affects many stroke survivors, making it difficult to read, speak, and understand language. Up to 70% of people with aphasia struggle with reading, which impacts their ability to communicate, work, and engage in daily life. The study aims to test a new approach to reading rehabilitation by combining Phono-Motor Treatment (PMT), a language therapy adapted to improve reading, with transcranial direct current stimulation (tDCS), a safe and painless brain stimulation technique. tDCS delivers a mild electrical current to the brain, which may enhance learning. This study will assess whether adding tDCS to PMT improves reading therapy outcomes.

Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Naming in Aphasic Patients.

High-Definition Transcranial Direct Current Stimulation (HD-tDCS) allows to induce, in a non-invasive way, a transient inhibitory or excitatory neuromodulation of a given cerebral region and to obtain a very focused cortical effect. Previous studies using HD-tDCS have shown the effectiveness of this stimulation technique for enhancing language recovery in patients with aphasia. However, language processes are not determined solely by local neural activity at a single site, but rather by the interaction between neural networks. This is because a large cortical network is involved in language processes and, therefore, the same language disorder may result from lesions at different locations in this network. The investigators hypothesize that anodal HD-tDCS will enhance neural interactions between language areas and, thereby, improve language processing and word learning. The investigators propose to carry out a study on chronic aphasic patients involving HD-tDCS of the Broca region (left inferior frontal gyrus) combined with a verb learning task.

Effectiveness of Intensive Aphasia Therapy Under Routine Clinical Conditions

The purpose of this study is to examine whether 3 weeks of intensive language therapy provided in clinical in- and outpatient settings is effective in improving everyday communication in postacute/chronic post-stroke aphasia, as measured by performance on the Amsterdam Nijmegen Everyday Language Test (ANELT).

Effects of Aphasia Identification Cards on Service Workers' Comprehension of People With Aphasia

The goal of this clinical trial is to learn whether healthy volunteers are more successful at understanding people with aphasia if they have first viewed an aphasia identification (ID) card. The main questions this study aims to answer are: * Does viewing an aphasia ID card improve healthy volunteers' understanding of the language errors made by people with aphasia? * Does viewing an aphasia ID card improve healthy volunteers' understanding of people with aphasia who make long pauses in their speech? Researchers will compare aphasia ID cards to a control condition (no ID card) to see whether aphasia ID cards improve healthy volunteers' understanding. Healthy volunteers will visit the study site for a single session (about 2 hours long). During the session they will: * Complete brief tests of their vision, hearing and thinking * Listen to sentences produced by a speaker with aphasia while their eye movements are recorded * Complete a survey about the experience of listening to the speaker with aphasia

Transcranial Magnetic Stimulation + Language Therapy to Treat Subacute Aphasia

The goal of this clinical trial is to determine if Transcranial Magnetic Stimulation (TMS) combined with modified Constraint Induced Language Therapy (mCILT) is an effective treatment for aphasia when delivered in the subacute stage after stroke. The main questions this study aims to answer are: 1. Can TMS combined with mCILT improve overall speech? 2. Can we identify specific behavioral and biological characteristics that would benefit most from the TMS and mCILT treatment? Researchers will compare real TMS to sham (fake) TMS to see whether TMS can treat subacute aphasia. Importantly, this trial will use electric field guided TMS to identify optimal and individualized stimulation intensity and site targeting. Participants will: * Complete a screening and medical intake to determine eligibility * Undergo MRI scans * Participate in 10 consecutive sessions (Monday-Friday) of TMS and mCILT treatment * Complete follow-up assessments immediately and 4 months after treatment

Mirror Speech Entrainment: A Novel Technique for Voice Personalized Speech Entrainment for Nonfluent Aphasia

The goal of this clinical trial is to test the use of voice personalization through artificial intelligence (AI) voice cloning on speech entrainment tasks to improve language production of persons with aphasia (PWA). The main question the study aims to answer is: \- What is the impact of personalized voice on speech entrainment in PWA compared to traditional speech entrainment? Speech entrainment is a technique used by speech-language pathologists to improve the speech production of PWA. Traditionally, speech therapists act as the model for participants to speak along with to improve their speech production. This study proposes the use of one's own voice (digitally altered) to improve speech production. The study uses a mobile health approach to administer speech entrainment treatment through a mobile app. * Smartphones with the mobile app pre-installed will be mailed to participants at no cost. * Participants will complete treatment in the comfort of their homes. * The experimental treatments involve: mirror speech entrainment (speaking along to one's own voice) and traditional speech entrainment (speaking along to someone else's voice).

Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting

This study looks at whether transcranial Direct Current Stimulation (tDCS) can be effectively implemented in inpatient and outpatient rehabilitation settings during routine speech therapy for people who recently had a stroke and now have aphasia (difficulty speaking or understanding language)

Balancing Effortful and Errorless Learning in Naming Treatment for Aphasia

Aphasia is a language disorder caused by stroke and other acquired brain injuries that affects over two million people in the United States and which interferes with life participation and quality of life. Anomia (i.e., word- finding difficulty) is a primary frustration for people with aphasia. Picture-based naming treatments for anomia are widely used in aphasia rehabilitation, but current treatment approaches do not address the long-term retention of naming abilities and do not focus on using these naming abilities in daily life. The current research aims to evaluate novel anomia treatment approaches to improve long-term retention and generalization to everyday life. This study is one of two that are part of a larger grant. This record is for sub-study 1, which will adaptively balance effort and accuracy using speeded naming deadlines.

Development and Validation of Language and Communication Assessment Scales

The aim of speech therapy for people with aphasia is to improve their ability to communicate in daily life. Traditional evaluations focus on linguistic tasks, but they do not fully address everyday communication skills, which are crucial for creating personalized treatment goals. The study suggests a multimodal approach to language assessment, stressing the importance of gestures in communication. It calls for the development of tools that evaluate communication in a wider context, including factors like motivation, attention, awareness, and alternative communication strategies. Additionally, there is a need for tools specifically designed to assess communicative gestures.

Telerehabilitation for Aphasia (TERRA)

Speech-language therapy is generally found to be helpful in the rehabilitation of aphasia. However, not all patients with aphasia have access to adequate treatment to maximize their recovery. The goal of this project is to compare the efficacy of telerehabilitation or Aphasia Remote Therapy (ART) to the more traditional In-Clinic Therapy (I-CT).

Aphasia Physical EXercise Study: Randomized Trial

The goal of this clinical trial is to evaluate the effects of a high-intensity exercise program on recovery in individuals with post-stroke aphasia. The high-intensity exercise program has been specifically designed for individuals with post-stroke aphasia and includes an interval training full-body workout, which can increase cardiovascular fitness, improve muscle strength and motor performance, and maximize cognitive and language gains. The main question this study aims to answer is: • Does participation in a high-intensity exercise program lead to changes in physical health, language, cognitive, motor recovery, psychological and/or psychosocial domains? Participants will be randomly assigned to either a high-intensity exercise program (target intervention) or a low-intensity exercise program (control intervention) delivered over 12-weeks in a group setting. Outcome measures will be collected once immediately after the intervention period and once during the following 12-week maintenance period to capture short- and long-term effects of the exercise program.

HD-tDCS for Phonological Impairment in Aphasia

This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance language recovery.

Effects of Gesture Plus Verbal Treatment (GVT) in Cantonese Speakers With Aphasia

This research aims to explore the relative efficacy of Verbal-only and GVT on naming difficulty in Cantonese-speaking people with aphasia (PWA). The primary research question in this study is: "For Cantonese-speaking people with aphasia, what are the relative effects of verbal treatment compared to gesture plus verbal treatment (GVT) on verbal and gesture naming at different levels?" People with aphasia will be engaged in a repeated measures experimental design. Participants will be engaged in two phases of training. In the first phase, participants will be assigned to receive verbal-only treatment. To minimize and prevent the carry-over effects caused by the first intervention, a one-month washout period will be implemented before the start of the second phase. After a washout period, participants will switch to GVT in the second phase.

Chinese-Specific Speech Imagery Coding Using High-Density ECoG

The goal of this study is to investigate whether high-density electrocorticography (ECoG) signals recorded from the surface of the brain can be used to decode neural representations of Mandarin Chinese speech features, including lexical tone, without requiring overt speech movements. The study focuses on the development and evaluation of decoding algorithms based on neural activity recorded during clinically indicated neurosurgical procedures. The main questions it aims to answer are: Can high-density ECoG signals be decoded to reconstruct neural representations of Mandarin Chinese speech features, particularly lexical tone? Can neural activity recorded during silent auditory speech imagery be decoded to reconstruct tone-specific speech representations without actual articulation? The study includes two groups of adult patients with neurological conditions who require cortical electrode placement as part of clinically indicated care: A intraoperative high-density ECoG temporary coverage group, enrolling approximately 50 patients with functional-area glioma or drug-resistant epilepsy who undergo awake neurosurgery with temporary high-density ECoG coverage for clinical functional mapping. A permanent high-density ECoG implantation group, enrolling approximately 10 patients with severe speech or language impairment caused by neurological conditions such as stroke, brain tumors, amyotrophic lateral sclerosis (ALS), or locked-in syndrome, who receive permanent high-density cortical electrode implantation for long-term monitoring. Participants will: Complete preoperative clinical assessments as part of standard medical care, including brain imaging, language function evaluation, and routine neurological assessments Undergo clinically indicated awake neurosurgical procedures during which high-density ECoG electrodes are placed on the cortical surface for clinical functional localization Perform language-related tasks, such as listening to speech, imagining speech, and limited spoken responses, while brain electrical activity is recorded for approximately 20-30 minutes during surgery, without altering standard surgical procedures For participants in the permanent implantation group, participate in long-term follow-up visits approximately every 2 weeks or monthly for up to 12 months after surgery, including evaluation of signal quality and research-related analysis and optimization of decoding algorithms All surgical procedures involving temporary or permanent electrode placement are performed for clinical indications and have been approved through institutional ethical and scientific review. Participation in this study does not alter standard clinical care for the temporary recording group and does not require additional clinical procedures beyond routine treatment. This research aims to support the long-term development of silent brain-to-speech communication technologies for individuals with severe speech or motor impairments and to improve understanding of how frontal, parietal, and temporal brain regions represent imagined speech in tonal languages such as Mandarin Chinese.

Transcranial Magnetic Stimulation + Language Therapy to Treat Mild Aphasia

The goal of this clinical trial is to determine if Transcranial Magnetic Stimulation (TMS) combined with Speech-Language Therapy (SLT) is an effective treatment for mild aphasia in persons with chronic stroke. The main questions this study aims to answer are: 1. Can TMS combined with SLT improve conversational speech and comprehension? 2. Can we identify specific behavioral and biological characteristics that would benefit most from the TMS and SLT treatment? Researchers will compare real TMS to sham (fake) TMS to see whether TMS can treat post-stroke mild aphasia. Participants will: * Complete a screening and medical intake to determine eligibility * Undergo a MRI * Participate in 10 consecutive sessions (Monday-Friday) of TMS and SLT treatment * Complete follow-up assessments 2 and 4 months after treatment

Effect of Community Choir Singing in People With Chronic Post-stroke Aphasia

The goal of this randomized controled trial is to test the effects of assigning people with chronic post-stroke aphasia to 12 weekly choir sessions, compared to usual care. The main question it aims to answer is: Does the assignment to a choir singing program causes a beneficial effect on functional communication and language recovery as well as psychosocial outcomes compared to usual care in the rehabilitation of people with chronic post-stroke aphasia? Participants will have: 12 in-person choir-singing sessions (1 session/week, 1,5 h/session, total 18h) conducted by a choir master, and home singing training (3 x 30-minutes-sessions/week, total 18h)

Genetic and Cognitive Predictors of Aphasia Treatment Response

Aphasia, or language impairment after a stroke, affects approximately 2 million people in the United States, with an estimated 180,000 new cases each year. The medical community cannot predict how well someone with aphasia will respond to treatment, as some people with aphasia are poor responders to intervention even when participating in empirically supported treatments. There is a strong likelihood that genetics play a role in language recovery after stroke, but very little research has been dedicated to investigating this link. This study will investigate whether two genes and cognitive abilities, such as memory, predict responsiveness to aphasia therapy for word-retrieval difficulties.

Exploratory Evaluation of the Digital Therapeutic Device Zenicom for Subacute Stroke Aphasia

Clinical Trial Title A Multicenter, Single-Blind, Prospective, Randomized, Exploratory Clinical Trial to Evaluate the Safety and Efficacy of the Digital Therapeutic Device 'Zenicom' for Improving Aphasia in Patients with Subacute Stroke Clinical Trial Objectives To evaluate the efficacy of the digital therapeutic device Zenicom. To evaluate the safety of the digital therapeutic device Zenicom. Clinical Trial Period 6 months from the date of clinical trial plan approval by the Ministry of Food and Drug Safety (MFDS). Target Condition Patients with aphasia resulting from stroke lesions. Target Sample Size Total of 20 subjects (10 in the experimental group and 10 in the control group). Investigational Medical Device Zenicom Clinical Trial Methodology 1. Device Information A) Experimental Device: Digital Speech Therapy Application Group: Performs conventional speech therapy for 30 minutes daily + additional digital speech therapy program during the 2-week treatment period. B) Control Device: Conventional Speech Therapy Group: Performs only conventional speech therapy for 30 minutes daily during the 2-week treatment period. 2. Treatment Duration: Total 2 weeks (10 working days; total usage of 600 minutes or more). 3. Visits: Total of 3 visits including outpatient and therapy room visits. Visit 1 (T-1): Screening Visit 2 (T0): Baseline and Treatment initiation Visit 3 (T1): Post-treatment assessment Inclusion and Exclusion Criteria 1. Inclusion Criteria Patients who satisfy all of the following criteria: Adults aged 19 years or older. Patients confirmed by a specialist to have aphasia caused by a stroke lesion. Patients with first-ever subacute stroke (within 3 months of onset) diagnosed via radiological examination (CT, MRI). Patients diagnosed with aphasia based on the Speech Assessment (PK-WAB-R). Patients whose native language is Korean. Patients capable of voluntarily consenting to the study. 2. Exclusion Criteria Patients meeting any of the following criteria will be excluded: Progressive or hemodynamically unstable stroke. Patients with other neurological diseases suspected to affect language ability. Co-morbid major psychiatric disorders requiring continuous medication (e.g., Major Depressive Disorder, Schizophrenia, Bipolar Disorder, Dementia). Co-morbid major neurogenic diseases other than stroke. Confirmed history of degenerative neuropathy. Current or past substance or alcohol use disorder. Visual impairment (Low vision severity: visual acuity of 0.1-0.3 or lower). Intellectual disability. Illiteracy (unable to read and consent). Patients deemed inappropriate for participation for other reasons. Refusal to participate in the study. Suspension and Dropout Criteria 1. Suspension Criteria If circumstances observed during the trial make it judged unreasonable to continue the study. Occurrence of Serious Adverse Events (SAE). 2. Dropout Criteria The subject requests to stop participation or withdraws consent during the trial. The investigator determines that the subject cannot continue the trial due to adverse events (e.g., headache, eye fatigue, nausea, dizziness, etc.). The subject arbitrarily takes medication expected to affect the comparative evaluation of the investigational device during the trial. The dosage of medication that may affect the comparative evaluation of the investigational device is changed during the trial. Discovery of major protocol violations, such as violation of inclusion/exclusion criteria. The subject fails to attend scheduled visits and cannot be contacted. The subject fails to perform the digital speech therapy program for a total of 600 minutes or more. The investigator determines that the trial should be stopped for other reasons. Endpoints (Outcome Measures) 1. Primary Efficacy Endpoint Change in PK-WAB-R scores between T0 and T1 between groups. 2. Secondary Efficacy Endpoints Change in K-BNT scores between T0 and T1 between groups. Change in K-SAQOL-12 scores between T0 and T1 between groups. Statistical Analysis Methods To evaluate the change in PK-WAB-R between T0 and T1 between groups, an independent two-sample test will be used. Depending on the distribution of the change, a parametric method (Student's t-test) or a non-parametric method (Mann-Whitney U test) will be selected and applied. To evaluate the changes in K-BNT and K-SAQOL-12 between T0 and T1 between groups, an independent two-sample test will be used. Depending on the distribution of the change, a parametric method (Student's t-test) or a non-parametric method (Mann-Whitney U test) will be selected and applied.

Cognitive Functioning in Adults With Somatic Diseases and General Population From a Biopsychosocial Perspective

The goal of this observational study is to investigate cognitive functioning profiles in adults with neurologically recognized aphasic syndromes and general population. The study group consist of minimal 600 adults (over 18 y.o.) who will be examined by qualified diagnosticians. Participants will be evaluated with tasks related to the studied variables: memory, learning and language. Furthermore informations regarding past and present health condition will be collected from participants. The main questions it aims to answer are: 1. What is the profile of memory and learning among polish adults? 2. Do gender and age moderates patterns of memory and learning functioning among polish adults? 3. What is a specific pattern of language functioning in adults with neurologically recognized aphasic syndromes? 4. Do gender moderates specific patterns of language functioning in adults with neurologically recognized aphasic syndromes? Researchers will compare the following groups of adults: 1. general population/control group 2. with neurologically recognized aphasic syndromes 3. seniors (over 60 y.o.)