SynPhNe Therapy for Stroke Recovery
Recruiting in Palo Alto (17 mi)
Overseen byPaolo Bonato, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Spaulding Rehabilitation Hospital
Must not be taking: Botox
Disqualifiers: Cognitive impairment, Dementia, Seizures, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this study is to:
1. Assess the usability of the SynPhNe device in a home environment.
2. Evaluate the efficacy of the SynPhNe home use device to improve motor hand function in chronic stroke subjects as compared to standard care alone.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are receiving Botox injections, you must not have had them in the affected arm in the last 3 months and should not plan to have them during the study.
What data supports the effectiveness of SynPhNe Therapy for Stroke Recovery?
Research suggests that high-intensity therapy focused on movement quality can significantly reduce motor impairment after a stroke, especially when delivered early in the recovery process. Additionally, movement-based therapies are emerging as promising treatments to enhance brain plasticity (the brain's ability to adapt and change) and improve functional recovery after a stroke.
12345What makes SynPhNe Therapy unique for stroke recovery?
SynPhNe Therapy is unique because it focuses on enhancing stroke recovery by potentially leveraging neuroplasticity (the brain's ability to reorganize itself) and neurorecovery, which are not the primary focus of most current treatments that aim to reduce initial damage. This approach may offer a second window for treatment, promoting brain regeneration days or weeks after a stroke.
34678Eligibility Criteria
This trial is for chronic stroke survivors who had a stroke at least 6 months ago and have moderate hand weakness. They must be able to move two fingers slightly and follow instructions. People with severe cognitive issues, current therapy, recent Botox in the arm, poor balance, severe communication problems, high muscle tone or other major health issues can't join.Inclusion Criteria
I have moderate weakness in my arm.
I had a stroke more than 6 months ago.
I can move 2 fingers in my hand and my elbow without much pain.
Exclusion Criteria
I have trouble sitting up straight without support.
I have been diagnosed with a neurological condition, but it's not a stroke.
My stroke-affected arm has other health issues.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo 18 upper-extremity rehabilitation sessions over 6 weeks, using either the SynPhNe system or conventional therapy.
6 weeks
6 visits (in-person), 12 sessions (home-based)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, after therapy, and at 1 month follow-up.
4 weeks
3 visits (in-person)
Participant Groups
The study tests the SynPhNe platform—a device for home-based hand function training—against standard care alone. It aims to see if using SynPhNe along with some conventional therapy sessions is better at improving motor skills in the affected hand of stroke patients.
2Treatment groups
Experimental Treatment
Active Control
Group I: SynPhNe therapyExperimental Treatment1 Intervention
Subjects will be asked to participate in a program of 18 upper-extremity rehabilitation sessions of 60 minutes with SynPhNe platform, over 6 weeks. The sessions will emphasize wrist and fingers movements, including functional activities.
During week the two first weeks, 6 sessions will be done under therapist supervision at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. Over the next 4 to 5 weeks, 10 sessions following exercises prompted by the SynPhNe system will be done unsupervised at home (or under limited supervision at the hospital), 2 sessions will be done at Spaulding Rehabilitation Hospital to review exercises with the SynPhNe system.
Over the course of the study, participants will wear Axivity sensors to gather information about upper-extremity usage.
Group II: Conventional therapyActive Control1 Intervention
Subjects will be asked to participate in a program of 18 upper-extremity rehabilitation sessions of 60 minutes under therapist supervision over two weeks at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. The sessions will emphasize wrist and fingers movements, including functional activities.
During week the two first weeks, 6 sessions will be done under therapist supervision at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. The remaining 10 sessions will be done unsupervised at home, over approximately 4 weeks, and following the therapist home treatment plan. Over that time, 2 visits to Spaulding Rehabilitation will be made to review home treatment plan. Over the course of the study, participants will wear Axivity sensors to gather information about upper-extremity usage.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Spaulding Rehabilitation HospitalBoston, MA
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Who Is Running the Clinical Trial?
Spaulding Rehabilitation HospitalLead Sponsor
References
Safety and efficacy of recovery-promoting drugs for motor function after stroke: A systematic review of randomized controlled trials. [2019]To investigate the efficacy and safety of drug interventions to promote motor recovery post-stroke.
Comparing a Novel Neuroanimation Experience to Conventional Therapy for High-Dose Intensive Upper-Limb Training in Subacute Stroke: The SMARTS2 Randomized Trial. [2021]Evidence from animal studies suggests that greater reductions in poststroke motor impairment can be attained with significantly higher doses and intensities of therapy focused on movement quality. These studies also indicate a dose-timing interaction, with more pronounced effects if high-intensity therapy is delivered in the acute/subacute, rather than chronic, poststroke period.
Treatments for stroke. [2019]Stroke is the third leading cause of death and the leading cause of disability in developed countries, yet remains a poorly treated condition. Treatments for stroke can be aimed at acutely improving blood flow or protecting brain tissue against ischaemia, enhancing stroke recovery or reducing the risk of stroke recurrence. This paper reviews each of these approaches, particularly focusing on mechanisms for which there are agents in clinical trials. There are a number of appealing neuroprotective agents in Phase II and III clinical trials. However, the majority of acute treatments are likely to suffer from a narrow therapeutic time window and hence limited patient access. Combinations of acute approaches are likely to offer the greatest benefit, but present challenges in development. Promotion of recovery following stroke offers enormous potential for successful therapeutic intervention. Excitingly, new developments in preclinical research have identified possible ways in which this may be achieved.
The development of stroke therapeutics: promising mechanisms and translational challenges. [2022]Ischemic stroke is the second most common cause of death worldwide and a major cause of disability. Intravenous thrombolysis with rt-PA remains the only available acute therapy in patients who present within 3h of stroke onset other than the recently approved mechanical MERCI device, substantiating the high unmet need in available stroke therapeutics. The development of successful therapeutic strategies remains challenging, as evidenced by the continued failures of new therapies in clinical trials. However, significant lessons have been learned and this knowledge is currently being incorporated into improved pre-clinical and clinical design. Furthermore, advancements in imaging technologies and continued progress in understanding biological pathways have established a prolonged presence of salvageable penumbral brain tissue and have begun to elucidate the natural repair response initiated by ischemic insult. We review important past and current approaches to drug development with an emphasis on implementing principles of translational research to achieve a rigorous conversion of knowledge from bench to bedside. We highlight current strategies to protect and repair brain tissue with the promise to provide longer therapeutic windows, preservation of multiple tissue compartments and improved clinical success.
Neuronal plasticity and functional recovery after ischemic stroke. [2016]Ischemic stroke affects many new patients each year. The sequelae of brain ischemia can include lasting sensorimotor and cognitive deficits, which negatively impact quality of life. Currently, treatment options for improving poststroke deficits are limited, and the development of new clinical alternatives to improve functional recovery after stroke is actively under investigation. Anti-Nogo-A immunotherapy to reduce the central nervous system inhibitory environment, cell transplantation strategies, pharmacological agents, and movement-based therapies represent emerging treatments of poststroke deficits through enhancement of neuroanatomical plasticity.
Evolving toward effective therapy for acute ischemic stroke. [2016]Acute ischemic stroke is a common, devastating disorder without beneficial therapy. Recent advances concerning the pathophysiology of ischemic brain injury have led to the development of rational pharmacological interventions. Thrombolytic and cytoprotective therapies may be useful and are being evaluated in clinical trials. The design of adequate clinical trials to evaluate these promising therapies has also evolved based on experience. Potential therapy for acute ischemic stroke must be assessed in a large number of patients who are given the intervention within hours of onset using a neurological scoring scale and a disability scale. Several new magnetic resonance imaging technologies are emerging that should allow the clinician to rapidly and accurately identify ischemic brain lesions and to evaluate cerebral perfusion. The availability of potentially efficacious therapies for ischemic stroke evaluated in well-designed clinical trials with magnetic resonance imaging technology, which can also assess therapeutic effects in vivo, should lead to the emergence of therapy to improve the outcome of patients with ischemic stroke in the near future.
Investigational therapies for ischemic stroke: neuroprotection and neurorecovery. [2023]Stroke is one of the leading causes of death and disability worldwide. Current treatment strategies for ischemic stroke primarily focus on reducing the size of ischemic damage and rescuing dying cells early after occurrence. To date, intravenous recombinant tissue plasminogen activator is the only United States Food and Drug Administration approved therapy for acute ischemic stroke, but its use is limited by a narrow therapeutic window. The pathophysiology of stroke is complex and it involves excitotoxicity mechanisms, inflammatory pathways, oxidative damage, ionic imbalances, apoptosis, angiogenesis, neuroprotection, and neurorestoration. Regeneration of the brain after damage is still active days and even weeks after a stroke occurs, which might provide a second window for treatment. A huge number of neuroprotective agents have been designed to interrupt the ischemic cascade, but therapeutic trials of these agents have yet to show consistent benefit, despite successful preceding animal studies. Several agents of great promise are currently in the middle to late stages of the clinical trial setting and may emerge in routine practice in the near future. In this review, we highlight select pharmacologic and cell-based therapies that are currently in the clinical trial stage for stroke.
New perspectives on developing acute stroke therapy. [2007]The development of additional acute stroke therapies to complement and supplement intravenous recombinant tissue-type plasminogen activator within the first 3 hours after stroke onset remains an important and pressing need. Much has been learned about the presumed target of acute stroke therapy, the ischemic penumbra, and clinically available imaging modalities such as magnetic resonance imaging and computed tomography hold great promise for at least partially identifying this region of potentially salvageable ischemic tissue. Understanding the biology of ischemia-related cell injury has also evolved rapidly. New treatment approaches to improve outcome after focal brain ischemia will likely be derived by looking at naturally occurring adaptive mechanisms such as those related to ischemic preconditioning and hibernation. Many clinical trials previously performed with a variety of neuroprotective and thrombolytic drugs provide many lessons that will help to guide future acute stroke therapy trials and enhance the likelihood of success in future trials. Combining knowledge from these three areas provides optimism that additional acute stroke therapies can be developed to maximize beneficial functional outcome in the greatest proportion of acute stroke patients possible.