Post Traumatic Induced SpasticityNCT07583277
Selective Dorsal Rhizotomy as a Cost Effective and Safe Procedure as a Alternative to Intrathecal Baclofen Pump in Patients With Post Traumatic Spasticity
A study testing Selective dorsal rhizotomy with neuromonitoring in people with Post Traumatic Induced Spasticity, run by Assiut University.
Trial summary
The investigators will investigate the selective dorsal rhizotomy in post traumatic brain and spinal cord injury induced spasticity to evaluate the efficacy of this procedure in reducing the tone of the spastic muscle groups. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post Traumatic Induced Spasticity
- What is being tested?
- Selective dorsal rhizotomy with neuromonitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are four year-old and above of both sexes.
- Patient with post traumatic head and / or spinal injury-induced spasticity.
- Ambulant and non-ambulant patient.
Who cannot join
- Patient below age of four year.
- Other conditions induced- spasticity e.g. Strokes, CP, MS, Hereditary spastic paresis, ALS, tumors, infections and degenerative diseases.
- Patient underwent previous intrathecal baclofen pump administration.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Selective Dorsal Rhizotomy as a Cost Effective and Safe Procedure as an Alternative to Intrathecal Baclofen Pump in Patients With Post Traumatic Spasticity: Multi-center Cohort Study
The investigators will investigate the selective dorsal rhizotomy in post traumatic brain and spinal cord injury induced spasticity to evaluate the efficacy of this procedure in reducing the tone of the spastic muscle groups.
Selective dorsal rhizotomy is well established effective procedure in participants with cerebral palsy associated spasticity.
As low and middle income countries, intrathecal baclofen pump is expensive for patients.
Read the detailed description
Spasticity is a condition that represents a form of disability and it's associated in various conditions. Intrathecal baclofen pump is tried and has a good outcome in treatment spasticity. However, it has some aide effects and complications and also expensive.
Selective dorsal rhizotomy is a surgical procedure that represents an optional treatment for spasticity and established with cerebral palsy and hereditary spasticity.
Selective dorsal rhizotomy in participants with Post traumatic induced spasticity isn't established yet and not compared with the results of intrathecal baclofen.
SDR is a procedure applied under general anesthesia and with neuromonitoring.
- Conditions
- Post Traumatic Induced Spasticity
- Being tested
- Selective dorsal rhizotomy with neuromonitoring
- Keywords
- Selective dorsal rhizotomy, Spasticity, Post traumatic induced spasticity, Spinal cord injury, Traumatic brain injury
- Medical subject headings
- Muscle Spasticity, Spinal Cord Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective dorsal rhizotomy with neuromonitoringProcedure or surgery
In prone position and Under general anaesthesia, and according to neuromonitoring, a microscopic cut of the rootlet ( of the dorsal root of spinal nerve) that supply the group that is most spastic
| Study group | Role | What they receive |
|---|---|---|
| Selective dorsal rhizotomy parm | Experimental | This will be the enrolled group of patients that will match the eligibility criteria and give the consent to undergo the surgery Receives: Procedure: Selective dorsal rhizotomy with neuromonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spasticity severity assessed by the Modified Ashworth Scale (MAS) and electromyography (EMG) amplitude
The primary outcome will be the reduction in spasticity, quantified by the change in MAS scores and EMG muscle activity measurements from baseline to post-intervention. The MAS score, ranged from 0 to 4 as 0 represents no increase in muscle tone and 4 indicates rigid limb flexion/extension, will be reported as the mean change in points, and EMG data will be summarized using the mean and standard deviation of muscle activity amplitude during standardized stretch protocols. The data will be analyzed to determine the statistical significance of improvements following the selective dorsal rhizotomy procedure
Measured: From one week to six months post operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Induced SpasticityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afnan Morad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583277
- Sponsor's protocol ID
- SDR
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
He J, Luo A, Yu J, Qian C, Liu D, Hou M, Ma Y. Quantitative assessment of spasticity: a narrative review of novel approaches and technologies. Front Neurol. 2023 Jul 5;14:1121323. doi: 10.3389/fneur.2023.1121323. eCollection 2023.
PubMed 37475737Shourijeh MS, Stampas A, Chang SH, Korupolu R, Francisco GE. Advancements in Understanding Spasticity: A Neuromusculoskeletal Modeling Perspective. J Clin Med. 2025 Nov 15;14(22):8092. doi: 10.3390/jcm14228092.
PubMed 41303128Lindsay C, Simpson J, Ispoglou S, Sturman SG, Pandyan AD. The early use of botulinum toxin in post-stroke spasticity: study protocol for a randomised controlled trial. Trials. 2014 Jan 8;15:12. doi: 10.1186/1745-6215-15-12.
PubMed 24401159Ertzgaard P, Campo C, Calabrese A. Efficacy and safety of oral baclofen in the management of spasticity: A rationale for intrathecal baclofen. J Rehabil Med. 2017 Mar 6;49(3):193-203. doi: 10.2340/16501977-2211.
PubMed 28233010Enslin JMN, Langerak NG, Fieggen AG. The Evolution of Selective Dorsal Rhizotomy for the Management of Spasticity. Neurotherapeutics. 2019 Jan;16(1):3-8. doi: 10.1007/s13311-018-00690-4.
PubMed 30460456
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Dorsal Rhizotomy as a Cost Effective and Safe Procedure as an Alternative to Intrathecal Baclofen Pump in Patients With Post Traumatic Spasticity: Multi-center Cohort Study
- ClinicalTrials.gov ID
- NCT07583277
- Acronym / sponsor ID
- SDR
- Conditions
- Post Traumatic Induced Spasticity
- Keywords
- Selective dorsal rhizotomy, Spasticity, Post traumatic induced spasticity, Spinal cord injury, Traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will investigate the selective dorsal rhizotomy in post traumatic brain and spinal cord injury induced spasticity to evaluate the efficacy of this procedure in reducing the tone of the spastic muscle groups.
Selective dorsal rhizotomy is well established effective procedure in participants with cerebral palsy associated spasticity.
As low and middle income countries, intrathecal baclofen pump is expensive for patients.
Detailed description
Spasticity is a condition that represents a form of disability and it's associated in various conditions. Intrathecal baclofen pump is tried and has a good outcome in treatment spasticity. However, it has some aide effects and complications and also expensive.
Selective dorsal rhizotomy is a surgical procedure that represents an optional treatment for spasticity and established with cerebral palsy and hereditary spasticity.
Selective dorsal rhizotomy in participants with Post traumatic induced spasticity isn't established yet and not compared with the results of intrathecal baclofen.
SDR is a procedure applied under general anesthesia and with neuromonitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selective dorsal rhizotomy parm | Experimental | Procedure: Selective dorsal rhizotomy with neuromonitoringThis will be the enrolled group of patients that will match the eligibility criteria and give the consent to undergo the surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are four year-old and above of both sexes.
- Patient with post traumatic head and / or spinal injury-induced spasticity.
- Ambulant and non-ambulant patient.
Key exclusion criteria (3 listed)
- Patient below age of four year.
- Other conditions induced- spasticity e.g. Strokes, CP, MS, Hereditary spastic paresis, ALS, tumors, infections and degenerative diseases.
- Patient underwent previous intrathecal baclofen pump administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective dorsal rhizotomy with neuromonitoringIn prone position and Under general anaesthesia, and according to neuromonitoring, a microscopic cut of the rootlet ( of the dorsal root of spinal nerve) that supply the group that is most spastic | Procedure or surgery | Selective dorsal rhizotomy parm |
Primary outcome
Change in spasticity severity assessed by the Modified Ashworth Scale (MAS) and electromyography (EMG) amplitude
Time frame: From one week to six months post operative.
The primary outcome will be the reduction in spasticity, quantified by the change in MAS scores and EMG muscle activity measurements from baseline to post-intervention. The MAS score, ranged from 0 to 4 as 0 represents no increase in muscle tone and 4 indicates rigid limb flexion/extension, will be reported as the mean change in points, and EMG data will be summarized using the mean and standard deviation of muscle activity amplitude during standardized stretch protocols. The data will be analyzed to determine the statistical significance of improvements following the selective dorsal rhizotomy procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 37475737He J, Luo A, Yu J, Qian C, Liu D, Hou M, Ma Y. Quantitative assessment of spasticity: a narrative review of novel approaches and technologies. Front Neurol. 2023 Jul 5;14:1121323. doi: 10.3389/fneur.2023.1121323. eCollection 2023.
- Background: PubMed 41303128Shourijeh MS, Stampas A, Chang SH, Korupolu R, Francisco GE. Advancements in Understanding Spasticity: A Neuromusculoskeletal Modeling Perspective. J Clin Med. 2025 Nov 15;14(22):8092. doi: 10.3390/jcm14228092.
- Background: PubMed 24401159Lindsay C, Simpson J, Ispoglou S, Sturman SG, Pandyan AD. The early use of botulinum toxin in post-stroke spasticity: study protocol for a randomised controlled trial. Trials. 2014 Jan 8;15:12. doi: 10.1186/1745-6215-15-12.
- Background: PubMed 28233010Ertzgaard P, Campo C, Calabrese A. Efficacy and safety of oral baclofen in the management of spasticity: A rationale for intrathecal baclofen. J Rehabil Med. 2017 Mar 6;49(3):193-203. doi: 10.2340/16501977-2211.
- Background: PubMed 30460456Enslin JMN, Langerak NG, Fieggen AG. The Evolution of Selective Dorsal Rhizotomy for the Management of Spasticity. Neurotherapeutics. 2019 Jan;16(1):3-8. doi: 10.1007/s13311-018-00690-4.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Selective dorsal rhizotomy with neuromonitoring in people with Post Traumatic Induced Spasticity, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Afnan Morad (01113890330, afnanmrad45@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in spasticity severity assessed by the Modified Ashworth Scale (MAS) and electromyography (EMG) amplitude (time frame: From one week to six months post operative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07583277, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.