Clinical Research Directory

EFFECT OF ANODAL TRANSCRANIAL DIRECT CURRENT STIMULATION ON NAMING IN APHASIC PATIENTS WITH ACUTE ISCHEMIC STROKE

The use of transcranial direct current stimulation (tDCS) for the management of deficits developed in stroke is a relatively new type of management option. Many of the studies performed using tDCS have focused on improvements noted in hemiplegia as compared to aphasia, which is an equally disabling outcome of strokes. The results of these studies have not been conclusive and concordant with each other. In aphasia management, the majority of the studies have focused on chronic strokes. Since the use of tDCS is relatively new, the studies have not focused on a particular type of deficit or stroke. Very few studies have focused on the impact of solely using tDCS. Very few studies have focused on acute to subacute strokes. The results of the studies have, nevertheless, been encouraging. Improvements in aspects of language tested after a single session of tDCS are short-lived. There is an unmet need to probe the utility of repetitive tDCS on aspects of language function in patients who are aphasic due to acute stroke. There is also a paucity of data in the Indian scenario regarding the same.

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.

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

Randomised Controlled Trial of an Intensive Comprehensive Aphasia Programme for People With Post-Stroke Aphasia

Research question Does participation in an Intensive Comprehensive Aphasia Programme produce a meaningful change in the communication of people with aphasia, their quality of life and that of their carers? Background Aphasia is a persistent language disorder that severely impairs communicative abilities. Most commonly induced by a stroke, aphasia reduces quality of life more than any other condition. People with aphasia (PWA) and their carers feel abandoned by the NHS due to the limited treatment options available. Meanwhile, neuroscientific evidence suggests that PWA can make meaningful gains in communicative ability, mood, and quality of life if therapists are given enough time to work with them. Although studies indicate Intensive Comprehensive Aphasia Programmes (ICAPs) are effective ways to deliver such therapy, no randomised controlled trial (RCT) of an ICAP has yet been conducted. We propose conducting the first ever ICAP RCT. Aims and objectives Clinical: i) To test the efficacy of an ICAP in improving PWAs' language impairment, communicative ability, mood, and quality of life; ii) to measure the quantity and quality of therapy received in the community by the standard care group; iii) to assess the significance of age and time-since-stroke in PWA's responses to ICAP intervention. Mechanistic: To test whether combining baseline behaviour and MRI brain scans can usefully predict individual patients' responses to the ICAP treatment. Methods Our RCT will test the effect of an ICAP intervention by randomly assigning PWA and their carers to one of two groups receiving either ICAP or standard care at two participating sites. We aim to deliver 100 hours of ICAP therapy over a 4-week schedule to adult PWA who are more than 3 months post-stroke. We will compare the effects of the ICAP, comprising complex interventions with multiple interacting therapeutic components, with standard care, the quantity and quality of which will be recorded by research assistants. The primary outcome measure is a standardized scale for measuring quality of life for PWA (SAQOL-39g). The primary endpoint is 4 months post-randomisation. We will also test for effects at 9 months. Anticipated impacts Our trial could provide the evidence needed to transform how the NHS treats PWA and their carers. If we demonstrate that participating in an ICAP leads to clinically meaningful and sustained improvements, the next stage in achieving wider NHS roll-out will be a multi-centre trial to investigate the cost- and clinical effectiveness of ICAPs across the UK.

Brain Stimulation Effects on Post-Stroke Fatigue and Aphasia

The goal of this clinical trial is to determine if electrical brain stimulation applied to the front parts of the brain can help people who have had a stroke improve their fatigue, language, and attention. The main question it aims to answer is: * Does transcranial direct current stimulation (tDCS) administered to the pre-frontal areas of the brain improve post-stroke fatigue and aphasia? * What kinds of participant characteristics are associated with better improvement of post-stroke fatigue and aphasia? Researchers will compare active electrical stimulation to sham stimulation to see if the active stimulation does a better job at reducing fatigue and language deficits after stroke. Participants will be asked to complete fatigue, language, and cognitive testing before and after receiving 10 sessions of tDCS plus speech and language therapy.

Comparing Traditional Semantic Feature Analysis (tSFA) and Semantic Feature Analysis + Metacognitive Strategy Training (SFA+MST)

The goal of this clinical trial is to compare the effectiveness of traditional Semantic Feature Analysis (SFA) treatment to a modified SFA protocol that includes Metacognitive Strategy Training (SFA+MST) for adults with acquired aphasia. The main questions it aims to answer are: * What are the comparative outcomes in picture naming accuracy and strategy use during picture naming following 2 months of traditional SFA versus SFA + MST in adults with acquired aphasia? * What are the comparative outcomes in percent of informative content and rate of informative content during spontaneous speech production following 2 months of traditional SFA versus SFA + MST in adults with acquired aphasia? Researchers will compare outcomes between these two treatments to see if SFA+MST yields larger effects in picture naming and spontaneous speech outcomes than traditional SFA. Participants will complete: * 5-7 pre-treatment assessment sessions where they will be asked to name pictures, tell stories/describe pictures, answer questions, and complete questionnaires, * 3 treatment sessions of SFA \*OR\* SFA+MST per week for 8 weeks, for a total of 24 sessions, * 7 weekly probes (i.e., short, intermittent assessments throughout the treatment phase), * 3 post-treatment assessment sessions immediately after treatment ends, where they will complete the same assessment tasks as they did pre-treatment (e.g., naming pictures, telling stories, etc.), * 2 retention assessment sessions, one 30 days and the other 60 days following the final treatment session, where they will be asked to name pictures, tell stories/describe pictures, and describe what they learned during the study.

Combined Aphasia and Robot-Assisted Arm Treatment for Chronic Stroke Survivors

The goal of this clinical trial is to learn if a program that combines language and arm treatment can improve language and movement problems in people with chronic stroke. The mains questions it aims to answer are: * To determine the extent to which this combined treatment can improve language. * To determine the extent to which the combined treatment can improve arm movements. Researchers will compare the effects of this combined treatment with treatment that targets arm movements alone.

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