SynPhNe Therapy for Stroke Recovery

Overseen By Motion Analysis Laboratory

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Must not be taking: Botox

Disqualifiers: Cognitive impairment, Dementia, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

40 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

What 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. ^{3 4 6 7 8}

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.

Research Team

Paolo Bonato, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Eligibility 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.

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)

Treatment Details

Interventions

• Conventional therapy
• SynPhNe platform

Trial Overview 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.

Participant Groups

Group I: SynPhNe therapy Experimental Treatment 1 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 therapy Active Control 1 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.

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Findings from Research

A systematic review of 50 randomized controlled trials involving 4,779 citations found that 18 out of 28 drug interventions significantly improved motor recovery post-stroke compared to placebo, indicating potential efficacy of these treatments.

Despite the promising results, the high risk of bias in many studies raises concerns about the reliability of the findings, highlighting the need for further research to optimize drug interventions and their combination with physical therapy for better stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of recovery-promoting drugs for motor function after stroke: A systematic review of randomized controlled trials. Firth, N., Barker, RN., Hayward, KS., et al.[2019]

In a study involving 24 patients with subacute stroke, both neuroanimation therapy (NAT) and modified conventional occupational therapy (COT) provided high-intensity upper-limb therapy, but there were no significant differences in motor recovery between the two approaches.

Both therapy groups showed improved recovery in the Action Research Arm Test compared to a historical cohort that received less therapy, suggesting that high-dose therapy can enhance upper-limb function after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing a Novel Neuroanimation Experience to Conventional Therapy for High-Dose Intensive Upper-Limb Training in Subacute Stroke: The SMARTS2 Randomized Trial. Krakauer, JW., Kitago, T., Goldsmith, J., et al.[2021]

Stroke remains a major health challenge, being the third leading cause of death and the top cause of disability in developed countries, with current treatments focusing on improving blood flow and protecting brain tissue.

While there are promising neuroprotective agents in advanced clinical trials, most acute treatments have limited effectiveness due to a narrow therapeutic time window, highlighting the need for combination therapies and new recovery-promoting strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatments for stroke. Beresford, IJ., Parsons, AA., Hunter, AJ.[2019]

Intravenous thrombolysis with rt-PA is currently the only acute treatment for ischemic stroke within 3 hours of onset, highlighting a significant need for more effective stroke therapies.

Advancements in imaging and understanding of biological responses to ischemia are leading to new strategies that may extend treatment windows and improve outcomes for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of stroke therapeutics: promising mechanisms and translational challenges. Zaleska, MM., Mercado, ML., Chavez, J., et al.[2022]

Emerging treatments for improving recovery after ischemic stroke include anti-Nogo-A immunotherapy, which aims to reduce inhibitory signals in the central nervous system, and cell transplantation strategies.

These new approaches, along with pharmacological agents and movement-based therapies, focus on enhancing neuroanatomical plasticity to help patients regain function and improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuronal plasticity and functional recovery after ischemic stroke. Cheatwood, JL., Emerick, AJ., Kartje, GL.[2016]

Recent advances in understanding ischemic brain injury have led to the development of new pharmacological therapies, including thrombolytic and cytoprotective treatments, which are currently being tested in clinical trials.

The use of advanced magnetic resonance imaging technologies is expected to enhance the identification of ischemic brain lesions and cerebral perfusion, facilitating the evaluation of these therapies and potentially improving outcomes for patients with acute ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving toward effective therapy for acute ischemic stroke. Fisher, M., Bogousslavsky, J.[2016]

Currently, the only FDA-approved treatment for acute ischemic stroke is intravenous recombinant tissue plasminogen activator, but its effectiveness is limited by a narrow therapeutic window.

Despite many neuroprotective agents showing promise in animal studies, consistent benefits in human trials have been elusive, although several potential therapies are in advanced clinical trials and may soon be available for routine use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigational therapies for ischemic stroke: neuroprotection and neurorecovery. Sahota, P., Savitz, SI.[2023]

There is a critical need for new acute stroke therapies to work alongside existing treatments like intravenous recombinant tissue-type plasminogen activator, especially within the first 3 hours after a stroke occurs.

Advancements in understanding the ischemic penumbra and the biology of cell injury, along with insights from past clinical trials, suggest that future therapies could leverage natural adaptive mechanisms to improve outcomes for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New perspectives on developing acute stroke therapy. Fisher, M., Ratan, R.[2007]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Safety and efficacy of recovery-promoting drugs for motor function after stroke: A systematic review of randomized controlled trials. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Comparing a Novel Neuroanimation Experience to Conventional Therapy for High-Dose Intensive Upper-Limb Training in Subacute Stroke: The SMARTS2 Randomized Trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Treatments for stroke. [2019]

4. England pubmed.ncbi.nlm.nih.gov

The development of stroke therapeutics: promising mechanisms and translational challenges. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Neuronal plasticity and functional recovery after ischemic stroke. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Evolving toward effective therapy for acute ischemic stroke. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Investigational therapies for ischemic stroke: neuroprotection and neurorecovery. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

New perspectives on developing acute stroke therapy. [2007]