Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-26 @ 1:20 AM
Study NCT ID:
NCT06070233
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2023-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}, {'id': 'D013097', 'term': 'Spermine Synthase'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D019883', 'term': 'Alkyl and Aryl Transferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-22', 'size': 275647, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-09-29T16:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2023-09-30', 'studyFirstSubmitQcDate': '2023-09-30', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Modified Ashworth Scale', 'timeFrame': '6 months post treatment', 'description': 'Change in the 6-month post-treatment Modified Ashworth Scale (MAS) measure of spasticity, which ranges from 0 (no symptoms) to 4 (worst symptoms)'}], 'secondaryOutcomes': [{'measure': 'Change in spasticity-related quality of life (SQoL-6D)', 'timeFrame': '2 years post treatment', 'description': 'Change in spasticity-related quality of life 6-dimensions instrument (SQoL-6D) over two years post-treatment, where the scale ranges from 0 (worst quality of life) to 100 (best quality of life)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Spasticity as Sequela of Stroke', 'Spastic Cerebral Palsy', 'Spasticity, Muscle']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic spasticity refractory to medical management or in a patient who cannot receive appropriate medical management mediated by one or more spinal nerve roots\n* Age \\> 16 (if under 18, patients parents must sign consent).\n\nExclusion Criteria:\n\n* Inability to lie supine for simulation \\& treatment\n* Inability to visualize the target nerve on either CT or MRI imaging\n* Patients with confirmed pregnancy (all women of child-bearing age with intact uterus \\& ovaries will be required to undergo a pregnancy test prior to simulation)'}, 'identificationModule': {'nctId': 'NCT06070233', 'acronym': 'SPASM', 'briefTitle': 'Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2022H0425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham Treatment', 'description': 'No intervention but can crossover after 6 months', 'interventionNames': ['Other: Sham']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SRS Treatment', 'interventionNames': ['Radiation: stereotactic radiosurgery (SRS) dorsal root rhizotomy radiomodulation']}], 'interventions': [{'name': 'stereotactic radiosurgery (SRS) dorsal root rhizotomy radiomodulation', 'type': 'RADIATION', 'description': 'Patients will be simulated in the supine position in an immobilization apparatus deemed by the treating physician to be appropriate for the patient being able to comfortably maintain position for the duration of treatment. All patients will be simulated and treated using free breathing. Prescription dose is 50 Gy delivered in a single fraction to the target volume, prescribed to whatever isodose line produces optimal falloff (but not less than a 50% isodose line; dmax \\<100Gy) .\n\nAll radiosurgery treatment will utilize the Varian Edge, Varian TrueBeam STx, or CyberKnife system', 'armGroupLabels': ['SRS Treatment']}, {'name': 'Sham', 'type': 'OTHER', 'description': 'Patients will be simulated in the supine position in an immobilization apparatus deemed by the treating physician to be appropriate for the patient being able to comfortably maintain position for the duration of treatment. All patients will be simulated and treated using free breathing.', 'armGroupLabels': ['Sham Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julia Pierson', 'role': 'CONTACT', 'email': 'jpierson@therenaissanceinstitute.org', 'phone': '321-972-1102'}, {'name': 'Evan Thomas, MD/PhD', 'role': 'CONTACT', 'email': 'ethomas@therenaissanceinstitute.org'}, {'name': 'Evan Thomas, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Renaissance Institute of Precision Oncology & Radiosurgery', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Uchechi Okafor', 'role': 'CONTACT', 'email': 'SPASMstudy@osumc.edu', 'phone': '614-293-4876'}, {'name': 'Brian Dalm, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Whitney Luke, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sheital Bavishi, DO', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Brian McMichael, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Joshua Palmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Uchechi Okafor, BS', 'role': 'CONTACT', 'email': 'SPASMstudy@osumc.edu', 'phone': '(614) 2934876'}], 'overallOfficials': [{'name': 'Joshua Palmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Varian Medical Systems', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Radiation Oncology', 'investigatorFullName': 'Joshua Palmer', 'investigatorAffiliation': 'Ohio State University'}}}}