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IRCT20200502047277N7 IRCT 2022-04-04 Shahid Beheshti University of Medical Sciences Selective dorsal rhizotomy in spinal cord injury-induced spasticity Safety and feasibility of selective dorsal rhizotomy in patients with spinal cord injury-induced spasticity 2022-03-28 anticipated 15 Complete https://irct.ir/trial/62581 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Condition 1: Injury of nerves and spinal cord at neck level. Condition 2: Unspecified injury of thoracic spinal cord. Intervention group: All patients in this study will undergo selective dorsal rhizotomy (SDR). The procedure includes partial section and division of dorsal nerve roots selected using intraoperative neurophysiologic monitoring. L1 to S1 nerve roots will be divided into rootlets of equal size. After that, electrical stimulation will be applied using intraoperative neurophysiologic monitoring and rootlets with greatest reflex responses will be cut.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Roozbeh Tavanaei
Functional Neurosurgery Research Center (FNRC), SBMU Shohada-E-Tajrish Educational Hospital, Tajrish Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2270 1022 rtavanaei@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Saeed Oraee Yazdani
Shohadaye Tajrish Hospital, Tajrish Ave.
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 saeed_o_yazdani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Modified Ashworth scale (MAS) of at least 3 and spasm frequency score (SFS) of at least 2 Patients with intractable spasticity after at least 6 months therapy with oral antispasmodic agents Candidates for intrathecal baclofen infusion who could not receive this therapy Age greater than 18 years Complete spinal cord injury or American Spinal Injury Association impairment scale (AIS) grade A Written informed consent obtained from the patient 18 years no limit Both Any brain lesion in areas involved in coordination or posture, such as basal ganglia or cerebellum based on MR imaging Any form of movement disorders, such as dyskinesia, dystonia, or ataxia Concurrent traumatic brain injury Genetic etiology for spasticity, such as hereditary spastic paraplegia Any evidence of a progressive neurological disorder Treatment with oral antispasmodic agents for less than six months Prior therapy with intrathecal baclofen pump Pregnancy or lactation Participation in another study during the present study period S14 S24.10 Injury of nerves and spinal cord at neck level Unspecified injury of thoracic spinal cord Treatment - Surgery Intervention group: All patients in this study will undergo selective dorsal rhizotomy (SDR). The procedure includes partial section and division of dorsal nerve roots selected using intraoperative neurophysiologic monitoring. L1 to S1 nerve roots will be divided into rootlets of equal size. After that, electrical stimulation will be applied using intraoperative neurophysiologic monitoring and rootlets with greatest reflex responses will be cut. Safety profile of the study intervention. Timepoint: Baseline, 1-week, 3- and 6-month postoperatively. Method of measurement: Monitoring and evaluating the patients regarding the adverse events. Modified Ashworth scale (MAS). Timepoint: Baseline, 1-week, 3- and 6-month postoperatively. Method of measurement: Physical examination and using the 6-point scale. Spasm frequency scale (SFS). Timepoint: Baseline, 1-week, 3- and 6-month postoperatively. Method of measurement: A self-report 5-point measure. Spinal cord injury spasticity evaluation tool (SCI-SET). Timepoint: Baseline and 6-month postoperatively. Method of measurement: Self-report questionnaire including 35 items. Visual analog scale (VAS) for spasticity. Timepoint: Baseline, 1-week, 3- and 6-month postoperatively. Method of measurement: 100 mm visual analog scale. Spinal cord independence measure (SCIM). Timepoint: Baseline and 6-month postoperatively. Method of measurement: Scoring using the measure based on clinical observation. Short Form 36 Health Survey Questionnaire (SF-36). Timepoint: Baseline and 6-month postoperatively. Method of measurement: Short Form 36 Health Survey Questionnaire (SF-36). Shahid Beheshti University of Medical Sciences Approved 2020-05-16 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences ,Shahid Arabi St., Yemen St., Shahid Chamran Highway, Tehran Tehran Tehran Iran (Islamic Republic of)