Outcome After Selective Dorsal Rhizothomy Concerning Life... | NCT03179241

Studies
Outcome After Selective Dorsal Rhizothomy Concerning Life Quality, Cerebral Imaging and Cognition

NCT03179241

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Jul 19, 2018Actual

Enrollment

180Estimated

Phase

Not provided

Conditions

Cerebral Palsy, Spastic

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 14, 2017Actual

Primary Completion Date

Oct 1, 2021Estimated

Completion Date

Dec 1, 2021Estimated

First Submitted Date

Jun 5, 2017

First Submission Date that Met QC Criteria

Jun 5, 2017

First Posted Date

Jun 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2018

Last Update Posted Date

Jul 19, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anne van Riesen, MD, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Selektive dorsal rhizotomy (SDR) has been used as treatment option in children suffering from cerebral palsy (CP) for several decades and multiple studies demonstrated its benefits. Nevertheless, there are still no proven strategies for patient selection, optimal point of time for the operation or pre- and postoperative therapies. The evaluation of the impact of selective motor control, cognition and cerebral imaging findings on the motor outcome and life quality in children with CP who underwent SDR at the Charité University clinics will clarify these critical points in daily care for patients with CP.

Detailed Description

SDR at the Charité University clinics. Two study visits before surgery and during the follow-up 3 months, 6 months, 12 months, 24 months and 5 years post-operatively.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Motor function measured by GMFCS	Ability of a child to perform specified motor tasks, measured by GMFCS and GMFM-88	5 years
Motor function measured by GMFM-88	Ability of a child to perform specified motor tasks, measured by GMFCS and GMFM-88	5 years

Secondary Outcomes

Measure	Description	Time Frame
Quality of life measured by "Disabkids"-Questionaire (German version)	Measured by "Disabkids"-Questionaire (German version) and "kid screen"	5 years
Quality of life measured by questionaire "kid screen"

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of cerebral palsy
able to perform most tasks according to study protocols
parents and physician decided to perform SDR

Exclusion Criteria:

not able to perform any tasks according to study protocols
no candidate for SDR

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

All patients treated with SDR at the Charité University clinics and who are able to perform tasks according to study protocols are eligible to enroll.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anne K van Riesen, M.D.	Contact	+4930450666547		anne.van-riesen@charite.de
Akosua S Sarpong-Bengelsdorf, M.D.	Contact	+4930450566607		Akosua.Sarpong@charite.de

Overall Officials

Name	Affiliation	Role
Anne K van Riesen, M.D.	social pediatric center, departement of neuropediatrics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité University clinics	Recruiting	Berlin		13353	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided