Stroke Clinical Trials

This study examines how to best assess and treat post-stroke neglect. This study will examine the preliminary effects of an innovative intervention (repetitive task-specific practice + transcranial direct current stimulation) for individuals with neglect. This study will also determine whether items from various neglect assessments can be combined to establish a more comprehensive neglect measure. Read Less

Portable Neuromodulation Stimulator (PoNS) is non-invasive stimulation device placed on the tongue to stimulate those brain regions understood to be important for maintaining balance. This research study aims to collect evidence that PoNS therapy along with balance training improves postural and walking stability post-stroke. Read Less

This study will compare two approaches to cognitive rehabilitation in adults with stroke with persistent, mild to moderate, cognitive impairment. Both approaches will feature a web-based computer "game" that trains cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. This training is termed Speed of Processing Training (SOPT). One approach will add (A) in-lab training on everyday activities with important cognitive components and (B) procedures designed to transfer improvements in cognition from the treatment setting to everyday life. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will add (A) in-lab training on relaxation, healthy nutrition, and healthy sleep and (B) procedures designed to promote integration of these lifestyle changes into everyday life. This approach is termed Brain Fitness-Heath Education Lifestyle Program (BF-HELP). Both CICT and BF-HELP will involve 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life; The set of the latter procedures is termed the Transfer Package. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. Family caregivers in both groups will also receive training on how to best support participants in their therapeutic program. The study will also test if there is an advantage to placing follow-up phone calls after treatment ends. The purpose of the calls will be to support transition of any behavioral changes achieved during treatment into everyday life on a long-term basis. Participants will be randomly assigned to the interventions. Testing will happen one month before treatment, one day before treatment, one day afterwards, and 6- and 12-months afterwards. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life. Read Less

The investigators will conduct a randomized, double-blinded, sham-controlled trial of approximately 60 patients with minor stroke and post-stroke mild cognitive impairment (psMCI). Participants will be individually randomized on enrollment using a random number generator to treatment with anodal tDCS + computerized cognitive treatment (CCT) versus sham + CCT (approximately 30 patients in each arm). Clinical evaluation including assessment of cognition will be performed pre- and post-intervention by individuals on the study team blinded to the participant's intervention. Participants will also undergo functional neuroimaging with magnetoencephalography (MEG) pre- and post-intervention (1, 3, and 6 months post-stroke to evaluate for initial and longer-term effects of treatment on cerebral activation patterns and functional connectivity). Neuroimaging and clinical outcomes will be assessed to determine the effect of tDCS versus sham + CCT on psMCI. Read Less

Sickle Cell Disease (SCD) is a rare disease occurring in an estimated 100,000 individuals, often poor and underserved, in the US. Silent and overt strokes contribute significantly to morbidity in adults with SCD, resulting in functional impairment, challenges with school and job performance, and premature death. Five NIH-funded randomized controlled trials have identified therapies to prevent silent and overt strokes in children with SCD, including monthly blood transfusion therapy (for preventing initial and recurrent strokes) and hydroxyurea (for preventing initial strokes). Despite the observation that at least 99% of children with SCD in high-income countries reach adulthood, and approximately 60% of adults will experience one or more strokes (\~50% with silent strokes and \~10% with overt strokes), no stroke trials have established therapeutic approaches for adults with SCD. For adults with SCD, inadequate evidence-based guidelines exist for secondary stroke prevention strategies. Applying stroke prevention strategies in children may not be effective for stroke prevention in adults with SCD, particularly given the high rate of co-morbidities. Identifying subgroups of adults with SCD and higher incidence coupled with the contribution of established stroke risk factors in the general population (smoking, diabetes, obesity, renal disease) will provide the requisite data required for the first-ever phase III clinical trials focused on secondary stroke prevention in adults. Read Less

The proposed research is relevant to public health because stroke is a leading cause of long-term disability among older adults and communication impairments resulting from stroke have a significant negative impact on quality of life. By seeking to better understand post-stroke aphasia, this project lays the groundwork for development of new interventions, and aligns with NIDCD's priority areas 1 (understanding normal function), 2 (understanding diseases), and 3 (improving diagnosis, treatment, and prevention). Read Less

The purpose of this study is to develop and test if upper limb task practice and muscle activity training improve upper limb function in stroke survivors. Participants will be asked to come to the laboratory 23 times (approximately 3 times a week) over 2.5 months to receive upper limb task practice, muscle activity training, and/or upper extremity functional assessments. Read Less

It is common for individuals after stroke to have a cognitive perceptual impairment called unilateral spatial neglect (neglect). Individuals with neglect have difficulty paying attention to one side of their body or one side of the environment and therefore experience difficulty performing daily activities. There are a lack of effective treatments for neglect and new interventions are needed to help reduce disability for these individuals. Metacognitive strategy training (strategy training) is an intervention that has the potential to reduce neglect-related disability and improve individuals' awareness of their neglect. This study seeks to examine the effects of strategy training on self-awareness, disability, and neglect. Read Less

The use of simulators to retrain driving skills of patients with stroke, Parkinson's disease (PD), or multiple sclerosis (MS) is very limited because of cost, space required, and incidence of simulator sickness in high fidelity simulators. The Principal investigator recently developed a low cost low fidelity portable driving simulator (PDS). In this pilot study, the study team will (1) determine the ease of use and occurrence of simulator sickness while operating the low fidelity PDS in a clinic setting and (2) the efficacy of the low fidelity PDS to reproduce the benefits from retraining impaired driving skills of stroke survivors in a high-fidelity simulator. Participants: 30 participants, separated according to neurological condition including stroke, PD, or MS, will be randomly allocated to either the PDS or fixed-base high-fidelity simulator training. Each participant will undergo a pre-training evaluation, five hours of designated training and a post-training assessment, similar to the pre-training evaluation. Data will be analyzed according to study aims. The investigators hypothesize that the simple set up of the PDS will make it easier to use and better decrease the incidence of simulator sickness that typically leads to stopping therapy than the high-fidelity simulator. The investigators hypothesize that improvements in lane maintenance, adherence to speed limits, reaction to traffic lights, and overall reaction time after training using the PDS will not be significantly different from improvements observed after training using the high-fidelity driving simulator. Read Less

This study is a randomized and open comparative study that uses two parallel groups: a control group training with conventional therapy and another group that trains with the device "Miraπ". The participants are patients with stroke with motor weakness in one hand. Two measurement visits are required. During those visits, different hand function assessments will be carried out to analyze the motor function of the subjects hand. The measurements will be done during their inpatient rehabilitation stay, one at time of admission and the second at discharge, each taking 20 minutes. In the time between the measurement visits, the hand therapy takes place fivemtimes a week. Read Less

The purpose of this study is to use Transcranial Magnetic Stimulation (TMS) while subjects are making reaching movements in a robotic arm device in order to discover how different brain areas control movement before and after stroke and when these brain areas are most sensitive to TMS. Read Less

This is a randomized, pilot interventional study in participants with visual field deficit (VFD) caused by cortical lesion. Damage to the primary visual cortex (V1) causes a contra-lesional, homonymous loss of conscious vision termed hemianopsia, the loss of one half of the visual field. The goal of this project is to elaborate and refine a rehabilitation protocol for VFD participants. It is hypothesized that visual restoration training using moving stimuli coupled with noninvasive current stimulation on the visual cortex will promote and speed up recovery of visual abilities within the blind field in VFD participants. Moreover, it is expected that visual recovery positively correlates with reduction of the blind field, as measured with traditional visual perimetry: the Humphrey visual field test or an eye-tracker based visual perimetry implemented in a virtual reality (VR) headset. Finally, although results will vary among participants depending on the extent and severity of the cortical lesion, it is expected that a bigger increase in neural response to moving stimuli in the blind visual field in cortical motion area, for those participants who will show the largest behavioral improvement after training. The overarching goals for the study are as follows: Group 1a will test the basic effects of transcranial random noise stimulation (tRNS) coupled with visual training in stroke cohorts, including (i) both chronic/subacute ischemic and chronic hemorrhagic VFD stroke participants, and (ii) longitudinal testing up to 6 months post-treatment. Group 1b will test the effects of transcranial tRNS coupled with visual training on a Virtual Reality (VR) device in stroke cohorts, including both chronic/subacute ischemic and chronic hemorrhagic VFD stroke participants. Group 2 will examine the effects of tRNS alone, without visual training, also including chronic and subacute VFD stroke participants and longitudinal testing. Read Less