Brain Functional Connectivity Changes Following Cognitive... | NCT01628276

Studies
Brain Functional Connectivity Changes Following Cognitive Rehabilitation in Multiple Sclerosis: an fMRI Study

NCT01628276

Sponsor

Sina Hospital, Iran

Status

Completed

Last Update Posted

Sep 12, 2014Estimated

Enrollment

45Actual

Phase

Not Applicable

Conditions

MS (Multiple Sclerosis)

Interventions

Cog Rehab

Countries

Iran

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 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Sep 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Jun 20, 2012

First Submission Date that Met QC Criteria

Jun 22, 2012

First Posted Date

Jun 26, 2012Estimated

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 11, 2014

Last Update Posted Date

Sep 12, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This trial seeks to investigate brain network changes following cognitive rehabilitation in MS patients. The investigators hypothesize that rehabilitation interventions improve connectivity in the brain.Novel Magnetic Resonance Imaging technique is performed to investigate changes in brain plasticity.

Detailed Description

Not provided

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

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Rehab first	Experimental	Behavioral: Cog Rehab
Rehab Second	Experimental	Behavioral: Cog Rehab
Non Rehab	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cog Rehab	Behavioral	Cognitive rehab for MS patients	Rehab Second Rehab first

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
functional connectivity	Changes in correlation of brain activity in different regions of brain as assessed by Blood Oxygenation Level Dependent (BOLD) signal	0, 2nd, 4th Month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Definitive MS diagnosis
Right handedness
EDSS 0-4
No relapse in past 6 weeks
Willing to consent and participate in the study

Exclusion Criteria:

Pregnancy
Left handedness
Neurologic or psychiatric disorder other than MS

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

54 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sina Hospital		Tehran	Tehran Province		Iran

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided