Treatment Trials

80 Clinical Trials for Various Conditions

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RECRUITING
Motor Recovery Through Plasticity-Inducing Cortical Stimulation
Description

Using the CorTec Brain Interchange (BIC) System, we will examine the effect of a plasticity-inducing therapy regime on the rehabilitation of upper limb impairment post-stroke. This study's main objective is to implement and evaluate neuroplasticity-inducing stimulation. The stimulation methods for inducing neuroplasticity have been selected based on prior preclinical and intraoperative work that has shown promise in providing rehabilitative benefits for stroke patients. We will be structuring this study as an open prospective feasibility study.

RECRUITING
Implementation of IVS3 for Upper Limb Motor Recovery
Description

This study measures participant satisfaction and upper extremity function in outpatients with chronic stroke when exposed to the IVS3 device. Investigators hypothesize that treatment with the IVS3 device will be feasible and tolerable for use in the outpatient setting.

RECRUITING
CUped: An Approach to Motor Recovery Post-Stroke, Not Compensation
Description

The goal of lower limb rehabilitation after stroke is recovery of independent walking at home and in the community. Few stroke survivors achieve this goal. Suboptimal outcomes are due to the serious and intransigent nature of movement impairments caused by stroke and the scarcity of feasible and effective therapies that restore movement lost to stroke. Our team has developed a novel exercise intervention called CUped (pronounced cupid, like the Roman god) to address barriers to recovery and improve walking after stroke. CUped is so called because it compels use of the paretic limb during a movement that resembles pedaling. This project will examine safety, acceptability, and tolerance to CUped, characterize its therapeutic effects, and identify dose-response relationships. Results will provide preliminary data for an R01 to support a randomized controlled trial (RCT). CUped is designed to help stroke survivors recover lower limb movement lost to stroke, thereby improving walking. It is intended to be used as an adjunct to gait training. CUped uses a robotic technology that eliminates compensatory movements that interfere with recovery, compels use of the paretic lower limb, and targets 3 key movement impairments caused by stroke: decreased muscle output from the paretic limb, inappropriate paretic muscle timing, and abnormal interlimb coordination. Exercise is done in sitting which enables high repetition practice. Like walking, CUped requires continuous, reciprocal use of both lower limbs; effects are likely to transfer to walking. The risk-reward profile of this proposal is ideal for an R21, which is an NIH funding opportunity intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development. CUped is a novel therapy grounded in a physiologic premise and based on prior observations from our laboratory. The investigators have pilot data suggesting that CUped fulfills its design specifications, and this study will be the first to test its therapeutic effects. In this Stage 1 rehabilitation trial, The investigators will support or quickly refute the hypothesis that CUped is safe, acceptable, and capable of eliciting a therapeutic response in stroke survivors. The investigators will also examine tolerance to CUped and dose-response effects. If our hypotheses are supported, the investigators will be poised to run an RCT to isolate the effects of CUped and compare them to standard care. Future work will investigate physiologic mechanisms underlying the effects of CUped.

NOT_YET_RECRUITING
tACS for Sensory Motor Recovery After Stroke
Description

The overall goal is to investigate the effectiveness of a novel intervention - transcranial alternating current stimulation (tACS) for motor recovery in stroke survivors.

Conditions
RECRUITING
Upper Limb-based Movement Priming for Lower Limb Neuroplasticity & Motor Recovery in Stroke
Description

The goal of this clinical trial is to to determine the effect of movement-based priming using the upper limbs on lower limb neuroplasticity and behaviors in chronic stroke. The main questions we aim to answer are: 1. What are the acute effect of UL-priming on lower limb neuroplasticity and motor behaviors in persons with stroke compared to other priming modalities? 2. What are the time effects of UL-priming on neuroplasticity and motor behavior in individuals with stroke? In this cross over study, participants will be involved in three priming sessions involving - UL-priming using rhythmic, symmetric, bilateral priming involving the movement of at least one major joint in the upper limbs. AND - Sham priming using auditory stimulation (1 Hz metronome). AND - Lower-limb movement-based priming using rhythmic, symmetric, dorsiflexion and plantarflexion movements. Researchers will compare outcome measures between the different priming sessions.

Conditions
RECRUITING
Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury
Description

So far, therapies have limited success in functional recovery in adults with chronic SCI. By introducing remote cognitive multisensory rehabilitation (CMR), which has shown significant functional improvements due to neurological recovery when delivered in-person, transformative results that (i) provide a potentially effective new therapy within the healthcare system, accessible to more patients, and (ii) demonstrate brain function changes alongside improved function in chronic SCI are anticipated. The results will inform and justify a large scale federally funded clinical trial.

RECRUITING
Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
Description

The recovery from a stroke is often incomplete. It is the leading cause of acquired permanent disability in the adult population. Persistent functional loss of the hand and arm contributes significantly to disability. However, the current standard of care to treat hand and arm movements are inadequate. There is an urgent need for innovative and effective therapies for recovery of the upper limb after stroke. Growing evidence shows that electrical spinal cord stimulation, combined with activity-dependent rehabilitation, enables voluntary movement of paralyzed muscles in some neurologic disorders, such as spinal cord injury. The investigators hypothesize that spinal networks that lost control after stroke can be activated by non-invasive electrical stimulation of the spinal cord to improve functional recovery. The aims of the study are: 1. to determine the improvements in hand and arm function that result from the combined application of non-invasive spinal stimulation and activity-based rehabilitation. Surface electrodes placed over the skin of the neck will be used for non-invasive electrical stimulation of the spinal cord. Functional task practice will be used for activity-dependent rehabilitation, 2. to evaluate long-lasting benefits to hand and arm function that persist beyond the period of spinal stimulation.

TERMINATED
Neural Mechanisms of Motor Recovery With Technology Assisted Training
Description

Stroke is a leading cause of disability that often impairs arm function and activities of daily living. The costs of rehabilitation are significant and practical constraints often limit therapy to the first few months after stroke. However many studies have shown that patients in the later stages post-stroke can still continue to benefit from rehabilitation. Technology-assisted therapy may offer a means to efficiently provide ongoing therapies to patients in the later stages (\>6 months) post-stroke. This study will determine which patients are best able to benefit from this therapy approach, and will also expand our knowledge of which brain structures need to be intact for patients to benefit from technology-assisted training. The results of this study will help to improve rehabilitation and quality of life for disabled Americans.

COMPLETED
A Clinical Trial of Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery in Adults With Spinal Cord Injury
Description

To provide an effective treatment for recovery from paralysis and improved quality of life of veterans, military, and civilians with spinal cord injury/disorder (SCI/D). This is a mechanistic Phase I randomized pilot clinical trial in 16 adults with SCI/D. The investigators will compare the effects of Cognitive Multisensory Rehabilitation (CMR) vs. adaptive fitness on sensorimotor function. Objective 1: Determine if 8 weeks of CMR improves sensory and motor function in adults with SCI/D. Objective 2: Determine if 8 weeks of CMR restores brain activity and connectivity related to sensorimotor function in adults with SCI/D.

NOT_YET_RECRUITING
BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment After a Long-term Use (Pilot).
Description

The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with moderate impairment after a long-term use.

Conditions
NOT_YET_RECRUITING
BreEStim for Motor Recovery in Chronic Stroke With Severe Impairment (Pilot)
Description

The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with severe impairment.

Conditions
NOT_YET_RECRUITING
BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment (Pilot).
Description

The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with moderate impairment.

Conditions
TERMINATED
Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis
Description

Individuals who experienced a stroke over one year ago will be randomly assigned to receive 1 of 4 different conditions of brain stimulation. All individuals will receive therapy of the hand and arm following the stimulation. This study will try to determine which brain stimulation condition leads to the greatest improvement in hand and arm function.

RECRUITING
Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke
Description

This study will examine the combination of myoelectric computer interface (MyoCI) training with targeted memory reactivation (TMR) in chronic stroke survivors. The study aims to determine whether this training-plus-sleep combination will generalize to improve arm motor function over an extended training protocol in stroke survivors.

Conditions
RECRUITING
Motor rECovery witH eArly imagiNg In STroke
Description

This study will contribute to the field of stroke rehabilitation research by expanding the investigator's understanding of the neural mechanisms responsible for the development and expression of abnormal flexion synergy, a primary movement impairment due to stroke. The study will longitudinally evaluate motor tract morphology and motor impairment/function in an attempt to develop early neuroimaging-based predictors of the development of flexion synergy and its impact on reaching and hand recovery (6 month). The study will utilize quantitative motor testing (kinematics and kinetics) to measure motor impairment and reaching and hand function. Both neuroimaging and quantitative motor testing will be conducted within 96 hours-, 2 weeks-, 3 months-, and 6 months-post stroke. The knowledge gained by this study will provide crucial structural and functional neuroimaging evidence that demonstrates the timeline of progressive ipsi- and contralesional motor pathway (including bulbospinal pathways) changes and the associated development of flexion synergy that grossly impacts reaching and hand function in individuals with moderate to severe stroke.

Conditions
COMPLETED
Transcranial Direct Current Stimulation for Post-stroke Motor Recovery
Description

This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate specific parts of the brain affected by stroke. The adjunctive rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT). During this therapy the subject will wear a mitt on the hand of the arm that was not affected by a stroke and force to use the weak arm. The study will test 3 different doses of brain stimulation in combination with mCIMT to find out the most promising one.

UNKNOWN
Study of the Guardian System on Motor Recovery and Impact on Length of Stay in Ischemic Stroke Patients
Description

This is a non-blinded randomized study that will investigate whether the use of a novel, non-invasive perfusion enhancement system (The Guardian System) impacts motor recovery and hospital length of stay in acute ischemic stroke patients.

Conditions
TERMINATED
Transcutaneous Vagus Nerve Stimulation for Motor Recovery After Stroke
Description

This study will evaluate the safety and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 intervention sessions occurring daily for 30 minutes over 2 weeks. The safety and improvements in arm motor function after the intervention will be compared in patients receiving RAVANS to those receiving sham stimulation.

COMPLETED
Electric Field Navigated 1hz Rtms for Post-stroke Motor Recovery Trial
Description

A prospective, multi-center, randomized, sham-controlled, blinded study combining active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardized task oriented rehabilitation will be conducted in patients with post-stroke motor impairment of the upper limb. The therapy will be provided for 6 weeks and primary outcome assessed 6 months later.

Conditions
COMPLETED
Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients
Description

In this study investigator's aim to assess the effect of a type of non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) in conjunction with fluoxetine on motor recovery after stroke.

COMPLETED
A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training
Description

The purpose of this study is to determine whether the combination of low frequency repetitive transcranial magnetic stimulation (rTMS) and motor-imagery-based brain computer interface (BCI) training is effective for enhancing motor recovery after stroke. The PI's hypothesis is that, in comparison with traditional physical therapy alone, subjects receiving supplementary rTMS and BCI training will show greater functional improvements in hand motor ability over time as well as recovery of normal motor connectivity patterns.

COMPLETED
Enhanced Motor Recovery Using Serotonergic Agents in Stroke
Description

The information derived from this study will be critical to establishing appropriate rehabilitative interventions post-stroke. In particular, traditional use of pharmacological agents to alter motor function post-stroke is directed primarily at reducing the "positive" signs following upper motor neuron lesion, in particular spasticity, or enhanced, velocity-dependent stretch reflex responses to imposed stretch. While pharmacological management of spasticity certainly suppresses clinical and quantitative measures of hypertonia, there is little improvement in functional performance. In contrast, preliminary data on the administration of 5HT agents following neurological injury indicates an increase in motor performance (Pariente 2001) and recovery (Dam 1996), despite an increase in spastic motor activity (Stolp-Smith 1999; see Preliminary Data below). Understanding methods to maximize function following stroke despite potential, short-term increases in spastic motor activity may improve therapeutic intervention strategies. The general objective of this study is therefore to: 1. quantify the effects of short-term SSRI administration on voluntary and spastic motor behaviors in individuals with chronic spastic hemiparesis, 2. identify the changes in impairments and functional recovery of walking ability during BWSTT with the presence or absence of SSRIs.

TERMINATED
Transcranial Direct Current Stimulation, Improve Functional Motor Recovery, Affected Arm
Description

Overall goal of this study is to determine if transcranial direct current stimulation (tDCS) plus conventional occupational therapy improves functional motor recovery in the affected arm-hand in patients after an acute ischemic stroke compared to sham tDCS plus conventional occupational therapy, and to obtain information to plan a large randomized controlled trial.

COMPLETED
Pilot Study - Comparison of Upper Body Ergometer Vs. Robot in Upper Extremity Motor Recovery Post-Stroke
Description

We will test whether robot driven, goal directed, trajectory corrected exercise enhances motor outcome in the upper limb of stroke patients better than matched motor activity on an upper body ergometer (monark).

Conditions
COMPLETED
Trial of Ropinirole in Motor Recovery After Stroke
Description

The purpose of this study is to assess efficacy, as well as safety, of Ropinirole in improving movement among patients with chronic stroke.

COMPLETED
Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis
Description

The results of this study will provide sound, scientific evidence of physiologic mechanisms responsible for upper-extremity weakness; evidence of the processes involved in neuromuscular adaptation; and will elucidate the relationship between impairment and motor disability in post-stroke hemiparesis.

COMPLETED
Motor Recovery in Recent Stroke Patients Treated With Amphetamine and Physical Therapy
Description

The purpose of this study is to determine if giving amphetamines along with standard rehabilitation speeds motor recovery after a stroke. In addition, if motor recovery is improved, the study will also identify the areas of the brain involved with the recovery. Researchers will use motor function ratings, PET scans, functional MRI (fMRI), electroencephalographs, and transcranial magnetic stimulation (TMS) to evaluate patients. Patients participating in the study will be placed in one of two groups; 1. Patients receiving dextroamphetamine and routine Rehabilitation Medicine 2. Patients receiving a placebo "sugar pill" and routine Rehabilitation Medicine Patients that have improved motor recovery will undergo neuroimaging and neurophysiological studies to identify areas of the brain involved.

RECRUITING
tDCS + CCFES-mediated Functional Task Practice for Post-stroke Upper Extremity Hemiplegia
Description

After a stroke, it is very common to lose the ability to open the affected hand. Occupational and physical rehabilitation therapy (OT and PT) combined with non-invasive brain stimulation may help a person recover hand movement. The purpose of this study is to compare 3 non-invasive brain stimulation protocols combined with therapy to see if they result in different amounts of recovery of hand movement after a stroke.

ACTIVE_NOT_RECRUITING
IMAS Optimization and Applicability in an Acute Stroke Setting.
Description

The investigator will investigate our Integrated sensor-based Motion Analysis Suite (IMAS) to objectively and quantitatively measure acute stroke patient motor status.

Conditions
RECRUITING
Trans Auricular Vagus Nerve Stimulation (taVNS) and Robotic Training for Paralyzed Arm After Stroke
Description

To determine whether treatment with transauricular vagus nerve stimulation (taVNS) during the training of an affected upper limb of a patient with chronic stroke on a robotic motor task alters the motor impairment.