Functional Neuroimaging of Postural Reconstruction | NCT01013727

Studies
Functional Neuroimaging of Postural Reconstruction

NCT01013727

Sponsor

University Hospital, Strasbourg, France

Status

Withdrawn

Last Update Posted

Oct 3, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

SPECT : ECD-Tc99m - Neurolite, Bristol-Myers Squibb Medical Imaging

Countries

France

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

Sep 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Nov 13, 2009

First Submission Date that Met QC Criteria

Nov 13, 2009

First Posted Date

Nov 16, 2009Estimated

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

Sep 29, 2025

Last Update Posted Date

Oct 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To study in two cross-sections of healthy volunteers, with single photon emission computed tomography (SPECT), the possible changes generated in the mid-term by two rehabilitation techniques: the postural reconstruction and the muscular stretching. The changes in the cortical activation patterns will be estimated during a non-specific position of the ankle, held static.

The influence of each technique will be estimated though the evidence of a change in the functional mapping of the areas activated during the defined motor task on healthy volunteers.

Detailed Description

This is a monocentre, randomized study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Postural Reconstruction	Experimental		Radiation: SPECT : ECD-Tc99m - Neurolite, Bristol-Myers Squibb Medical Imaging
muscular stretching	Active Comparator		Radiation: SPECT : ECD-Tc99m - Neurolite, Bristol-Myers Squibb Medical Imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPECT : ECD-Tc99m - Neurolite, Bristol-Myers Squibb Medical Imaging	Radiation		Postural Reconstruction muscular stretching

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the functional mapping of the areas activated during the defined motor task on healthy volunteers.		8 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male or female 18 to 35 years old

Exclusion Criteria:

pregnant, lactating

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Izzie Jacques Namer, Md	University Hospital, Strasbourg, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Strasbourg		Strasbourg		67000	France