NCT07583277

Brief 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. 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

April 28, 2026

Last Update Submit

May 8, 2026

Conditions

Post Traumatic Induced Spasticity

Keywords

Selective dorsal rhizotomySpasticityPost traumatic induced spasticitySpinal cord injuryTraumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • 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

    From one week to six months post operative.

Study Arms (1)

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

Procedure: Selective dorsal rhizotomy with neuromonitoring

Interventions

Selective dorsal rhizotomy with neuromonitoringPROCEDURE

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

Selective dorsal rhizotomy parm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 37475737BACKGROUND

  • Shourijeh 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.

    PMID: 41303128BACKGROUND

  • Lindsay 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.

    PMID: 24401159BACKGROUND

  • Ertzgaard 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.

    PMID: 28233010BACKGROUND

  • Enslin 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.

    PMID: 30460456BACKGROUND

MeSH Terms

Conditions

Muscle SpasticitySpinal Cord InjuriesBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBrain InjuriesBrain DiseasesCraniocerebral Trauma

Central Study Contacts

Afnan Morad

CONTACT

01113890330afnanmrad45@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 13, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 13, 2026

Record last verified: 2026-05