Radiosurgery for Spasticity

(SPASM Trial)

Recruiting at1 trial location

Overseen by Evan Thomas, MD/PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ohio State University

Disqualifiers: Pregnancy, Inability to lie supine, others

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.

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, since the trial is for people whose spasticity is not helped by their current medications, you might be able to continue them. It's best to ask the trial organizers for more details.

What data supports the effectiveness of the treatment Radiosurgery for Spasticity?

Research shows that Selective Dorsal Rhizotomy (SDR), a component of the treatment, effectively reduces spasticity (muscle stiffness) in children with cerebral palsy, as demonstrated in several studies that observed improvements in muscle function and gait. ^{1 2 3 4 5}

Is selective dorsal rhizotomy generally safe for treating spasticity?

Selective dorsal rhizotomy (SDR) is generally considered safe for reducing spasticity, with low complication rates reported in both children and adults. While spinal cord tethering has not been reported as a complication, the procedure is well tolerated with minimal risk of progressive lumbar instability. ^{2 4 6 7 8}

How is the treatment Stereotactic Radiosurgery Dorsal Rhizotomy different from other treatments for spasticity?

Stereotactic Radiosurgery Dorsal Rhizotomy is unique because it uses precise radiation to target specific nerve roots in the spine, unlike traditional surgical methods that involve cutting nerves. This non-invasive approach may offer a novel option for reducing spasticity without the need for open surgery. ^{1 4 9 10 11}

Research Team

Evan Thomas, MD/PhD

Principal Investigator

Ohio State University

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

I am older than 16 and if under 18, my parents have agreed to sign the consent.

My severe muscle stiffness hasn't improved with medication.

Exclusion Criteria

I cannot lie on my back for treatments.

The nerve we need to see cannot be seen on a CT or MRI scan.

I am not pregnant or have confirmed I am not pregnant through a test.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either stereotactic radiosurgery dorsal rhizotomy or a sham treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in spasticity and quality of life

6 months

Multiple visits (in-person and virtual)

Crossover Treatment

Participants who received the sham treatment are eligible to receive the real treatment

1 day

1 visit (in-person)

Long-term Follow-up

Participants are monitored for long-term changes in spasticity-related quality of life

2 years

Treatment Details

Interventions

• Sham (Other)
• Stereotactic Radiosurgery Dorsal Rhizotomy (Radiation)

Trial Overview 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.

Participant Groups

Group I: SRS Treatment Active Control 1 Intervention

Group II: Sham Treatment Placebo Group 1 Intervention

No intervention but can crossover after 6 months

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Dr. John J. Warner

Ohio State University

Chief Executive Officer since 2023

MD, MBA

Dr. Peter Mohler

Ohio State University

Chief Medical Officer since 2023

PhD in Molecular Biology

Centro Diagnostico Milano, Co-PI: Pantaleo Romanelli, MD

Collaborator

Trials

1

Recruited

20+

Varian Medical Systems

Industry Sponsor

Trials

63

Recruited

3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

Findings from Research

In a study of 140 children with cerebral palsy undergoing selective dorsal rhizotomy (SDR), obesity was identified as a significant predictor of complications, including prolonged wound healing and superficial surgical site infections, with a notable odds ratio of 24.4 for wound healing issues.

The study found that while SDR is generally safe across all Gross Motor Functional Classification System (GMFCS) levels, non-ambulatory children (GMFCS IV and V) were more likely to require extended epidural pain management, highlighting the need for careful monitoring in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of postoperative complications after selective dorsal rhizotomy. Wach, J., Yildiz, ÖC., Sarikaya-Seiwert, S., et al.[2021]

Selective dorsal rhizotomy (SDR) is a safe surgical technique that effectively reduces spasticity and improves functional outcomes in children with spastic diplegia due to cerebral palsy, as indicated by various measures including the gross motor function measurement scale (GMFM).

Long-term studies show that SDR provides significant and lasting improvements in motor skills, strength, and daily activities, making it a valuable option for managing spasticity in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective dorsal rhizotomies in the treatment of spasticity related to cerebral palsy. Farmer, JP., Sabbagh, AJ.[2018]

In a study of 18 children with quadriplegic spastic cerebral palsy, selective dorsal rhizotomy (SDR) led to a significant decrease in spasticity across all muscle groups and a 3.2% improvement in overall motor function as measured by the Gross Motor Function Measure (GMFM).

Despite the reduction in spasticity, SDR did not prevent orthopedic complications, as indicated by unchanged hip migration and the need for further orthopedic surgeries in some children, highlighting the complexity of managing spastic cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective dorsal rhizotomy in children with cerebral palsy. Results in 18 cases at one year postoperatively. Hodgkinson, I., Bérard, C., Jindrich, ML., et al.[2018]

In a study of 38 patients with cerebral palsy undergoing single-level selective dorsal rhizotomy (SDR), it was found that ventral roots activated more muscles at lower stimulus thresholds compared to dorsal roots, indicating a clear physiological distinction that can guide surgical procedures.

The study established that approximately 64.72% of each rootlet was transected during SDR, and emphasized the need for individualized treatment plans due to variability in physiological responses among patients, including some with abnormal response characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiology of Sensory and Motor Nerve Root Fibers in Selective Dorsal Rhizotomies. Martinez, V., Browd, S., Osorio, M., et al.[2020]

Selective dorsal rhizotomy significantly alleviates spasticity in children with cerebral palsy, as evidenced by improved knee and hip ranges of motion that approached normal limits after 10 years.

The study, which involved 11 children with spastic diplegia and used quantitative gait analysis over a long-term follow-up, demonstrated lasting functional benefits in gait, although step length and velocity remained below normal levels after a decade.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait before and 10 years after rhizotomy in children with cerebral palsy spasticity. Subramanian, N., Vaughan, CL., Peter, JC., et al.[2022]

Selective dorsal rhizotomy (SDR) was found to be safe for adult patients with chronic spinal cord injury-induced spasticity, with no adverse events reported during the study involving 10 participants.

All secondary outcome measures, including spasticity and independence scores, showed significant improvement after SDR, suggesting potential efficacy in reducing spasticity and enhancing mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Potential Efficacy of Selective Dorsal Rhizotomy in Adults with Spinal Cord Injury-Induced Spasticity: An Open-Label, Non-Randomized, Single-Arm Trial. Oraee-Yazdani, S., Tavanaei, R., Rezaee-Naserabad, SS., et al.[2023]

Selective dorsal rhizotomy is an effective surgical procedure for reducing lower-extremity spasticity in children with cerebral palsy, and the authors present a modified technique that requires only a single-level laminectomy, which reduces operating time and postoperative pain.

In over 1500 patients treated since 1991, this modified procedure has shown to be well tolerated with a low complication rate, including only one case of cerebrospinal fluid leakage requiring repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical techniques of selective dorsal rhizotomy for spastic cerebral palsy. Technical note. Park, TS., Johnston, JM.[2022]

Two cases of spinal cord tethering were reported as a previously unrecognized complication following selective dorsal rhizotomy (SDR) performed below the conus medullaris in children with spastic diparetic cerebral palsy.

Both patients initially showed improvement in spasticity and gait after SDR, but later developed urinary incontinence, highlighting the need for careful monitoring for this rare complication post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord tethering after selective dorsal rhizotomy below the conus medullaris. Belanger, K., McKay, W., Oleszek, J., et al.[2022]

A study of 77 patients undergoing selective dorsal rhizotomy showed that motor responses to dorsal root stimulation are highly reproducible, with over 93% of dorsal roots showing consistent results between two stimulation trials.

The reliable intraoperative stimulation techniques help in accurately identifying abnormal rootlets, which is crucial for effectively reducing spasticity while preserving muscle strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of intraoperative electrophysiological monitoring in selective posterior rhizotomy. Mittal, S., Farmer, JP., Poulin, C., et al.[2004]

A survey of 19 centers performing lumbosacral selective dorsal rhizotomy (SDR) for spastic cerebral palsy revealed significant variation in electrophysiologic techniques, with only 11 out of 15 centers consistently using unipolar stimulating electrodes.

Despite some consistent practices, such as recording from multiple lower limb muscles and using tetanic stimulation, there was notable disagreement on key aspects like the type of stimulator used and how to define response thresholds, indicating a lack of standardization in the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variation between centers in electrophysiologic techniques used in lumbosacral selective dorsal rhizotomy for spastic cerebral palsy. Steinbok, P., Kestle, JR.[2018]

Selective dorsal rhizotomy (SDR) has been successfully used to treat trauma-induced spasticity, showing favorable outcomes in both children and adults with cerebral palsy, as well as in post-traumatic cases.

The procedure has demonstrated minimal complications, suggesting that SDR could be a valuable treatment option for patients suffering from disabling spasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of selective dorsal rhizotomy in the management of post-traumatic spasticity: systematic review. Agrawal, M., Samala, R., Doddamani, R., et al.[2021]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Predictors of postoperative complications after selective dorsal rhizotomy. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Selective dorsal rhizotomies in the treatment of spasticity related to cerebral palsy. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Selective dorsal rhizotomy in children with cerebral palsy. Results in 18 cases at one year postoperatively. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Electrophysiology of Sensory and Motor Nerve Root Fibers in Selective Dorsal Rhizotomies. [2020]

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

Gait before and 10 years after rhizotomy in children with cerebral palsy spasticity. [2022]

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

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]

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

Surgical techniques of selective dorsal rhizotomy for spastic cerebral palsy. Technical note. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Spinal cord tethering after selective dorsal rhizotomy below the conus medullaris. [2022]

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

Reliability of intraoperative electrophysiological monitoring in selective posterior rhizotomy. [2004]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Variation between centers in electrophysiologic techniques used in lumbosacral selective dorsal rhizotomy for spastic cerebral palsy. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

The role of selective dorsal rhizotomy in the management of post-traumatic spasticity: systematic review. [2021]