A randomised, sham controlled trial of dorsal root rhizotomy stereotactic radiosurgery versus standard of care for spasticity associated with stroke, spinal cord injury & cerebral palsy
A Randomized, Sham Controlled Trial of Dorsal Root Rhizotomy Stereotactic Radiosurgery Versus Standard of Care for Spasticity Associated With Stroke, Spinal Cord Injury & Cerebral Palsy.
The landscape of medical interventions for spasticity management is continuously evolving and The International Organisation for Radiotherapy for Benign Conditions (IORBC) welcomes a new noteworthy study: “A Randomized, Sham Controlled Trial of Dorsal Root Rhizotomy Stereotactic Radiosurgery Versus Standard of Care for Spasticity Associated With Stroke, Spinal Cord Injury & Cerebral Palsy”.
The study, led by Prof. Dr. Evan Thomas of The Ohio State University Wexner Medical Center and supported by collaborators including the Milano Institute for Neurodegenerative Disorders and Varian Medical Systems. The study, which commenced in October 2023, is an interdisciplinary effort to decipher the complex mechanisms underpinning the therapeutic benefits of stereotactic radiosurgery and is expected to have a completion date of December 2026.
Stereotactic radiosurgery is an established non-invasive ablative therapy that has been previously researched for its efficacy in treating conditions including the management of adenomas, artero-venous malformations, refractory cardiac arrhythmias & trigeminal painful syndromes.
Selective dorsal rhizotomy (SDR) has been highlighted as one of the best modalities available for treating patients with cerebral palsy (CP) who experience spasticity, particularly in mobile spastic diplegia. Whilst previous research acknowledges positive short-term and long-term outcomes of SDR, suggesting its efficacy in reducing spasticity and improving the quality of life for CP patients, the molecular and neurological underpinnings of this treatment remain largely uncharted territory.
Dr. Evan Thomas’ placebo-controlled trial, dubbed RAD-SPAS01, is aimed at investigating the neuroprotective and spasticity-reducing effects of this innovative radiosurgical approach in patients afflicted with debilitating spasticity, a condition characterized by muscle stiffness and tightness affecting individuals with stroke, spinal cord injury, and cerebral palsy.
The study will aim to establish a scientific framework to substantiate the anecdotal evidence of this novel treatment modality. The placebo-controlled design will evaluate the efficacy of the treatment in alleviating spasticity and enhancing patient quality of life.
The focal point of the study will be the use of stereotactic radiosurgery dorsal rhizotomy (SRS) to alleviate the symptoms of spasticity. Through the application of highly precise radiation beams to target specific nerves, the treatment aims to reduce muscle stiffness, thus potentially enhancing the quality of life for those afflicted.
The study seeks to enroll 100 participants, divided into two groups: one receiving the actual stereotactic radiosurgery and the other a placebo treatment i.e. ‘sham group’.
The sham group will act as a critical control mechanism to ensure rigorous assessment of the treatment’s efficacy. Furthermore, those participants initially placed in the sham group will be afforded the opportunity to receive the actual treatment after a six-month period to ensure an ethical approach to this study research design. To be eligible for the study, participants must be over 16 years of age with chronic spasticity refractory to medical management and also covers exclusions including confirmed pregnancy among participants of childbearing potential.
According to the paper on Clinical Trials, the research will be “a double-blind, randomised, crossover assignment model, with a primary focus on treatment efficacy as measured by the Modified Ashworth Scale (MAS) and changes in spasticity-related quality of life (SQoL-6D) over a two-year period post-treatment.” Carried out internationally at locations including Columbus, Ohio, USA, and Milano, Italy under the stewardship of Prof. Dr. Evan Thomas and his colleague Dr. Pantaleo Romanelli, the research team will delve into the changes in neurological function and immune response among the participants.
The IORBC looks forward to sharing study insights into how targeted radiation therapy might modulate neurological pathways and immune system interactions in patients with spasticity in due course.”
