SDR Monitoring in Children With Cerebral Palsy
1 other identifier
observational
148
1 country
1
Brief Summary
The study evaluates the anatomical distribution of the assessed Electromyogram (EMG) responses ensuring after sensory nerve root stimulation and obtained IOM grading during selective dorsal rhizotomy (SDR) with regard to level and, side of the body and gender as well as pain management and outcome data.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2007
Longer than P75 for all trials
1 active site
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
Study Start
First participant enrolled
January 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2015
CompletedFirst Submitted
Initial submission to the registry
March 8, 2017
CompletedFirst Posted
Study publicly available on registry
March 14, 2017
CompletedJanuary 4, 2018
January 1, 2018
7.9 years
March 8, 2017
January 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The frequency distribution pattern of the grading assessed by SDR monitoring Electromyogram (EMG) procedure
During the operation
Secondary Outcomes (25)
Intensive care unit length of stay
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Length of hospital stay
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Ready to discharge
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Duration of ventilation
Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day
Pain
Up to 12 months
- +20 more secondary outcomes
Study Arms (1)
Children
Children who underwent selective dorsal rhizotomy (SDR) including intraoperative neuromonitoring (IOM)
Eligibility Criteria
Male and female pediatric and adolescent patients undergoing SDR
You may qualify if:
- Male and female children with spastic cerebral palsy undergoing selective dorsal rhizotomy surgery including intraoperative neuromonitoring
You may not qualify if:
- \> 21 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité University Medicine -Berlin
Berlin, 13353, Germany
Related Publications (1)
Wolter S, Spies C, Martin JH, Schulz M, Sarpong-Bengelsdorf A, Unger J, Thomale UW, Michael T, Murphy JF, Haberl H. Frequency distribution in intraoperative stimulation-evoked EMG responses during selective dorsal rhizotomy in children with cerebral palsy-part 1: clinical setting and neurophysiological procedure. Childs Nerv Syst. 2020 Sep;36(9):1945-1954. doi: 10.1007/s00381-020-04734-z. Epub 2020 Jun 23.
PMID: 32577878DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Claudia Spies, MD, Prof.
Charite University, Berlin, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany
Study Record Dates
First Submitted
March 8, 2017
First Posted
March 14, 2017
Study Start
January 15, 2007
Primary Completion
November 27, 2014
Study Completion
December 2, 2015
Last Updated
January 4, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share