Radiosurgery for Spasticity (SPASM Trial)
Palo Alto (17 mi)Overseen byEvan Thomas, MD/PhD
Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Ohio State University
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?A scientific study is being done to test a special treatment for people who have spasticity or tight muscles. This treatment is called "stereotactic radiosurgery dorsal rhizotomy." It uses very accurate beams of radiation to target certain nerves in the back to help loosen up the muscles. In this study, people are put into two groups by chance: one group gets the real treatment, and the other group gets a "fake" treatment that doesn't do anything. This fake treatment is called a "sham." Doing this helps make sure the study is fair and the results are true. After the people in the study get their treatment, the researchers will watch and see how they do. They will check if their muscles are less stiff and if they have any side effects. By looking at the results from both groups, the researchers can find out if the special treatment really helps people with spasticity. Patients who got the "fake" treatment will be eligible to receive the "real" treatment after 6 months.
Is Stereotactic Radiosurgery Dorsal Rhizotomy a promising treatment for spasticity?Yes, Stereotactic Radiosurgery Dorsal Rhizotomy is a promising treatment for spasticity. It is similar to Selective Dorsal Rhizotomy, which has been successful in reducing spasticity in patients with cerebral palsy and post-traumatic conditions. This treatment can help improve movement and reduce muscle stiffness, making it a valuable option for those affected by spasticity.14789
What safety data is available for radiosurgery in treating spasticity?The safety data for selective dorsal rhizotomy (SDR), a related procedure, indicates it is generally safe with low complication rates. Studies have shown sustained improvements in spasticity with minimal risks, such as spinal cord tethering not being reported as a complication. In over 1500 patients, only one cerebrospinal fluid leak required repair. SDR is well tolerated in both children and adults, with decreased operating time and postoperative pain.5671011
What data supports the idea that Radiosurgery for Spasticity is an effective treatment?The available research shows that Selective Dorsal Rhizotomy (SDR), a form of radiosurgery for spasticity, is effective in reducing spasticity in children with cerebral palsy. Studies have shown that SDR can lead to improvements in movement and function. For example, one study found that children who underwent SDR had better outcomes in terms of reduced spasticity compared to those who only received physiotherapy. Another study highlighted improvements in gait, or walking ability, even 10 years after the procedure. These findings suggest that SDR can be a beneficial treatment for managing spasticity in cerebral palsy.23679
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, since the trial is for people with spasticity that doesn't respond to medical management, you might continue your current meds. Please check with the trial coordinators for more details.
Eligibility Criteria
This trial is for individuals over 16 years old with chronic spasticity from conditions like stroke, SCI, or cerebral palsy that doesn't improve with medication. If under 18, parental consent is needed. It's not for those who can't lie on their back for the procedure, if the target nerve isn't visible on scans, or if pregnant.Inclusion Criteria
My severe muscle stiffness hasn't improved with medication.
Exclusion Criteria
I cannot lie on my back for treatments.
I am not pregnant or have confirmed I am not pregnant through a test.
Treatment Details
The study tests a treatment called stereotactic radiosurgery dorsal rhizotomy which aims to reduce muscle stiffness by targeting nerves with radiation. Participants are randomly assigned to receive either this real treatment or a sham (fake) procedure to compare outcomes.
2Treatment groups
Active Control
Placebo Group
Group I: SRS TreatmentActive Control1 Intervention
Group II: Sham TreatmentPlacebo Group1 Intervention
No intervention but can crossover after 6 months
Stereotactic Radiosurgery Dorsal Rhizotomy is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Stereotactic Radiosurgery Dorsal Rhizotomy for:
- Spasticity associated with stroke
- Spasticity associated with spinal cord injury
- Spasticity associated with cerebral palsy
🇪🇺 Approved in European Union as Selective Dorsal Rhizotomy for:
- Spasticity in children with cerebral palsy
- Spasticity in adults with spinal cord injury
Find a clinic near you
Research locations nearbySelect from list below to view details:
Ohio State University Wexner Medical CenterColumbus, OH
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
Centro Diagnostico Milano, Co-PI: Pantaleo Romanelli, MDCollaborator
Varian Medical SystemsIndustry Sponsor
References
Variation between centers in electrophysiologic techniques used in lumbosacral selective dorsal rhizotomy for spastic cerebral palsy. [2018]The extent of variation between centers in the electrophysiologic techniques used in lumbosacral selective dorsal rhizotomy (SDR) for spastic cerebral palsy was studied using a questionnaire survey. Nineteen centers completed the questionnaire, and the responses were analyzed for those 16 centers in which the extent of dorsal root section was guided by intraoperative electrophysiologic responses. Consistent techniques included: use of unipolar stimulating electrodes (11 of 15 responses); stimulation
Gait before and 10 years after rhizotomy in children with cerebral palsy spasticity. [2022]Selective dorsal rhizotomy is a neurosurgical procedure performed for the relief of spasticity in children with cerebral palsy, but its long-term functional efficacy is still unknown. The authors sought to address this issue by means of an objective, prospective study in which quantitative gait analysis was used.
Selective dorsal rhizotomy in children with cerebral palsy. Results in 18 cases at one year postoperatively. [2018]Effects of selective dorsal rhizotomy (SDR) were studied in children with spastic cerebral palsy in orthopaedic and functional fields.
Reliability of intraoperative electrophysiological monitoring in selective posterior rhizotomy. [2004]Selective posterior rhizotomy is a well-established treatment for spasticity associated with cerebral palsy. At most medical centers, responses of dorsal rootlets to electrical stimulation are used to determine ablation sites; however, there has been some controversy regarding the reliability of intraoperative stimulation. The authors analyzed data obtained from the McGill Rhizotomy Database to determine whether motor responses to dorsal root stimulation were reproducible.
Surgical techniques of selective dorsal rhizotomy for spastic cerebral palsy. Technical note. [2022]Selective dorsal rhizotomy is a well-established surgical procedure for improving lower-extremity spasticity in children with cerebral palsy. The standard technique requires an L1-S1 laminectomy or laminoplasty for visualization of all dorsal nerve roots exiting at their respective foramina. The authors describe a rhizotomy procedure that requires a single-level laminectomy at the level of the conus, with the advantages of decreased operating time and postoperative pain as well as a minimal risk of progressive lumbar instability. This procedure is both effective and well tolerated in appropriately selected children and adults, and has had one cerebrospinal fluid lead requiring operative repair in more than 1500 patients treated at the authors' institution since 1991.
Selective dorsal rhizotomies in the treatment of spasticity related to cerebral palsy. [2018]Selective dorsal rhizotomy (SDR) is a surgical technique developed over the past decades to manage patients diagnosed with cerebral palsy suffering from spastic diplegia. It involves selectively lesioning sensory rootlets in an effort to maintain a balance between elimination of spasticity and preservation of function. Several recent long-term outcome studies have been published. In addition, shorter follow-up randomized controlled studies have compared the outcome of patients having undergone physiotherapy alone with those that received physiotherapy after selective dorsal rhizotomy.
Electrophysiology of Sensory and Motor Nerve Root Fibers in Selective Dorsal Rhizotomies. [2020]Spasticity remains a major impediment in the treatment of cerebral palsy (CP). The single-level selective dorsal rhizotomy (SDR) is a minimally invasive intervention that reduces spasticity in select patients. We provide a descriptive set of normative data that practitioners can utilize to help guide the single-level SDR procedure, including (1) physiological threshold values used to dissociate ventral from dorsal roots; (2) response characteristics of muscles; (3) descriptions of abnormal physiological responses; and (4) percentage of rootlets transected during surgery.
The role of selective dorsal rhizotomy in the management of post-traumatic spasticity: systematic review. [2021]There is a huge burden of patients suffering from trauma-induced disabling spasticity the world over. There are surprisingly few modalities of treatment with a sustained, proven benefit which can be offered to such patients. Selective dorsal rhizotomy (SDR) has been used with proven success in treating spasticity in patients of cerebral palsy, both in children and in adults. The rationale behind using the procedure in post-traumatic cases is reviewed, along with the cases reported till date in the world literature. The indications, surgical procedure used, outcome and complications, if any, are described. Most of the cases described in the literature have shown a favourable outcome with minimal complications. SDR can become an important tool in the armamentarium of the clinician treating this condition.
Predictors of postoperative complications after selective dorsal rhizotomy. [2021]Selective dorsal rhizotomy (SDR) reduces spasticity in children with cerebral palsy (CP). We analyzed potential preoperative predictors of complications after SDR via single-level laminectomy at the conus medullaris.
Spinal cord tethering after selective dorsal rhizotomy below the conus medullaris. [2022]Two techniques for selective dorsal rhizotomy (SDR) involve stimulating and sectioning nerve rootlets either below the conus medullaris or above the entrances to their respective dural root sleeves. In general, both techniques lead to sustained improvements in lower extremity spasticity with low complication rates. To our knowledge, spinal cord tethering has not been previously reported as a complication of SDR using either technique.
Safety and Potential Efficacy of Selective Dorsal Rhizotomy in Adults with Spinal Cord Injury-Induced Spasticity: An Open-Label, Non-Randomized, Single-Arm Trial. [2023]Despite the abundant literature on the use of selective dorsal rhizotomy (SDR) in spastic cerebral palsy, no investigation has evaluated its use in adult patients with chronic spinal cord injury (SCI)-induced spasticity. The present investigation aimed to evaluate the safety and potential efficacy of SDR in chronic SCI-induced spasticity for the first time.