Neuro-Innovators and Spaulding Rehabilitation Launch Study on Pharmacologically-Enhanced Therapy for Stroke Survivors

Study will evaluate whether combining neuroplastic therapeutics with rehabilitation can improve outcomes for chronic stroke survivors

PITTSBURGH, PA, UNITED STATES, April 9, 2026 /EINPresswire.com/ -- Neuro-Innovators, a clinical-stage pharmaceutical company developing therapies designed to enhance neuroplasticity, today announced a new milestone in its research collaboration with Spaulding Rehabilitation Hospital, a nationally ranked rehabilitation hospital and member of the Mass General Brigham healthcare system.

Under a Master Research Agreement executed in 2024, the organizations are initiating a Phase 1 investigator-initiated proof-of-concept study designed to assess whether Neuro-Innovators’ proposed pharmacotherapy, administered alongside structured stroke rehabilitation therapy, is safe and can enhance recovery of motor function in individuals six months or more after stroke.

Neuro-Innovators’ pharmacotherapy is a patent-pending oral combination therapy composed of three FDA-approved drugs, each known to influence mechanisms associated with neuroplasticity. When repurposed and used in conjunction with active rehabilitation, the combination is designed to support the brain’s ability to form new connections and improve responsiveness to therapy. Because each component has an established safety profile and proven access to the brain, Neuro-Innovators’ repurposing strategy is a faster and lower-risk development and commercialization strategy.

“Neuroplasticity is central to recovery after stroke, yet there are few therapies designed to actively support it,” said Howison Schroeder, Co-Founder and CEO of Neuro-Innovators. “This study is an important first step in evaluating the safety and feasibility of a practical pharmacologic approach designed to enhance the effectiveness of rehabilitation.”

The study will be led by two of the nation’s foremost experts in stroke rehabilitation: Qing Mei Wang, MD, PhD, physician investigator in the Department of Physical Medicine and Rehabilitation at the Mass General Research Institute, and Paolo Bonato, PhD, Director of the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. Both investigators have published extensively on stroke rehabilitation and recovery, bringing together complementary expertise in neuromotor rehabilitation and advanced robotics.

“Stroke remains the leading cause of long-term disability,” said Bonato and Wang. “There is a significant unmet need for therapies that can enhance the effectiveness of rehabilitation, particularly for patients in the chronic phase. We look forward to evaluating the potential of this therapeutic approach.”
Spaulding Rehabilitation Hospital was selected as the research partner for this study in recognition of its global leadership in stroke rehabilitation and its unique capabilities in deploying robot-assisted interventions. The Spaulding Motion Analysis Laboratory is among the most advanced facilities of its kind, enabling objective, high-resolution measurement of motor function generally not available in a standard clinical setting.

The Phase 1 study will enroll up to 40 patients. Participants will complete an eight-week rehabilitation protocol while receiving daily pharmacotherapy. The primary objective of the study is to evaluate the safety and tolerability of the Neuro-Innovators’ proposed pharmacotherapy when administered alongside active rehabilitation in individuals with chronic stroke. The study will also explore changes in upper-extremity motor function using the Fugl-Meyer Assessment Upper Extremity score, supported by objective robotic-based measures.

Neuro-Innovators expects study completion in 2027, after which the company plans to advance into a Phase 2(b) dosing study for NIV-001, its lead pharmacotherapy candidate. NIV-001 is a patent-pending oral combination of three FDA-approved drugs, each with an established clinical safety profile and demonstrated access to the central nervous system — making it a lower-risk development candidate than a novel molecular entity. Administered alongside active rehabilitation, NIV-001 is designed to support the brain's capacity for reorganization and recovery. The company intends to pursue a 505(b)(2) regulatory pathway (repurposing) with the FDA.

“Working with Drs. Bonato and Wang has been an exceptional experience,” said Mark Cochran, PhD, Director and COO of Neuro-Innovators. “Their depth of experience in stroke rehabilitation research is invaluable as we evaluate this combination therapy.”

As many as 5 million people in the United States live with chronic stroke-related motor impairment, a population for which there is currently no standard of care to restore lost function. Neuro-Innovators believes this represents a substantial unmet clinical need and commercial opportunity.

Individuals interested in learning more about participation in this study may contact the research team at Spaulding Rehabilitation Hospital. The study will enroll individuals who experienced a stroke six months or more prior and who continue to experience upper-extremity motor impairment.

Additional information about eligibility criteria and enrollment will be made available through Spaulding Rehabilitation Hospital and affiliated clinical research networks.

Patients, caregivers, or healthcare providers interested in learning more about Neuro-Innovators’ pharmacotherapy may contact the study team at j.schroeder@neuro-innovators.com.

About Neuro-Innovators

Healing Brains with Neuroplastic Medicine™
Neuro-Innovators is a first in class clinical-stage pharmaceutical company focused on developing compound therapies that engage multiple mechanisms of neuroplasticity to support recovery following stroke, brain injury, and other neurological conditions. The company’s mission is to improve functional outcomes for patients while reducing the long-term personal and societal burden of neurologic disability.

For more information, visit https://neuro-innovators.com

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Madelyn De Los Santos
Putnam Insights LLC
madelyn@putnaminsights.com

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