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Safety and feasibility of selective dorsal rhizotomy in patients with spinal cord injury-induced spasticity

Protocol summary

Study aim
The present study aims to assess the safety and feasibility of selective dorsal rhizotomy in patients with spinal cord injury-induced spasticity.
Design
This study is a single arm, nonblinded, nonrandomized, phase 1 clinical trial on 15 patients to assess the safety and feasibility of study intervention.
Settings and conduct
A total of 15 patients will undergo selective dorsal rhizotomy in the present single-arm clinical trial. Since the aim of this study is to assess the safety and feasibility of the intervention, randomization and blinding will not be performed. Patients will be evaluated regarding the study outcomes at baseline, 1-week, 3-, and 6-month postoperatively.
Participants/Inclusion and exclusion criteria
Patients with cervical or thoracolumbar complete spinal cord injury (SCI)-induced intractable spasticity refractory to treatment for at least six months, modified Ashworth scale of at least three, and spasm frequency score of at least two will be included. Patients who have spasticity with etiologies other than SCI, concurrent traumatic brain injury, or a history of prior therapy with intrathecal baclofen will be exculded.
Intervention groups
A total of 15 patients with complete spinal cord injury-induced spasticity, will undergo selective dorsal rhizotomy. The procedure includes laminectomy or laminoplasty followed by partial division of dorsal nerve roots using intraoperative neurophysiologic monitoring.
Main outcome variables
The primary outcome measure of the study was the safety profile of the study intervention. Secondary outcome measures included modified Ashworth scale, spasm frequency scale, spinal cord injury spasticity evaluation tool, visual analog scale for spasticity, spinal cord independence measure, and Short Form 36 Health Survey Questionnaire.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200502047277N7
Registration date: 2022-04-04, 1401/01/15
Registration timing: registered_while_recruiting

Last update: 2022-04-04, 1401/01/15
Update count: 0
Registration date
2022-04-04, 1401/01/15
Registrant information
Name
saeed oraee yazdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 25719
Email address
saeed_o_yazdani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-28, 1401/01/08
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and feasibility of selective dorsal rhizotomy in patients with spinal cord injury-induced spasticity
Public title
Selective dorsal rhizotomy in spinal cord injury-induced spasticity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences ,Shahid Arabi St., Yemen St., Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-05-16, 1399/02/27
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.580

Health conditions studied

1

Description of health condition studied
Injury of nerves and spinal cord at neck level
ICD-10 code
S14
ICD-10 code description
Injury of nerves and spinal cord at neck level

2

Description of health condition studied
Unspecified injury of thoracic spinal cord
ICD-10 code
S24.10
ICD-10 code description
Unspecified injury of thoracic spinal cord

Primary outcomes

1

Description
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

Secondary outcomes

1

Description
Modified Ashworth scale (MAS)
Timepoint
Baseline, 1-week, 3- and 6-month postoperatively
Method of measurement
Physical examination and using the 6-point scale

2

Description
Spasm frequency scale (SFS)
Timepoint
Baseline, 1-week, 3- and 6-month postoperatively
Method of measurement
A self-report 5-point measure

3

Description
Spinal cord injury spasticity evaluation tool (SCI-SET)
Timepoint
Baseline and 6-month postoperatively
Method of measurement
Self-report questionnaire including 35 items

4

Description
Visual analog scale (VAS) for spasticity
Timepoint
Baseline, 1-week, 3- and 6-month postoperatively
Method of measurement
100 mm visual analog scale

5

Description
Spinal cord independence measure (SCIM)
Timepoint
Baseline and 6-month postoperatively
Method of measurement
Scoring using the measure based on clinical observation

6

Description
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)

Intervention groups

1

Description
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.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Saeed Oraee Yazdani
Street address
Shohadaye Tajrish hospital, Tajrish Square.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Saeed_o_yazdani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
7th Floor, Building Number.2, Shahid Beheshti University of Medical Sciences, Arabi Avenue, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roozbeh Tavanaei
Position
Research associate
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Functional Neurosurgery Research Center (FNRC), SBMU Shohada-E-Tajrish Educational Hospital, Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2270 1022
Email
rtavanaei@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Oraee Yazdani
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Shohadaye Tajrish Hospital, Tajrish Ave.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
saeed_o_yazdani@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roozbeh
Position
Research associate
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Functional Neurosurgery Research Center (FNRC), SBMU Shohada-E-Tajrish Educational Hospital, Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2270 1022
Email
rtavanaei@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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