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

This study is currently recruiting participants.
Verified December 2012 by Sina Hospital, Iran
Sponsor:
Information provided by (Responsible Party):
Mohammad Ali Sahraian, Sina Hospital, Iran
ClinicalTrials.gov Identifier:
NCT01628276
First received: June 20, 2012
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
MS (Multiple Sclerosis)
 Behavioral: Cog Rehab

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sina Hospital, Iran:

Primary Outcome Measures:
  • functional connectivity [ Time Frame: 0, 2nd, 4th Month ] [ Designated as safety issue: No ]
    Changes in correlation of brain activity in different regions of brain as assessed by Blood Oxygenation Level Dependent (BOLD) signal


Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rehab first Behavioral: Cog Rehab
Cognitive rehab for MS patients
Experimental: Rehab Second Behavioral: Cog Rehab
Cognitive rehab for MS patients
No Intervention: Non Rehab

  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628276

Contacts
Contact: Arman Eshaghi, MD 00989125270900 arman.eshaghi@me.com
Contact: Alireza Borghei, MD 00989124548351 a.borghei@me.com

Locations
Iran, Islamic Republic of
Sina Hospital Recruiting
Tehran, Iran, Islamic Republic of
Contact: Arman Eshaghi     00989125270900     arman.eshaghi@me.com    
Sponsors and Collaborators
Sina Hospital, Iran
  More Information

No publications provided

Responsible Party: Mohammad Ali Sahraian, Vice President, Sina Hospital, Iran
ClinicalTrials.gov Identifier: NCT01628276     History of Changes
Other Study ID Numbers: MSRC-AE-DCM-1
Study First Received: June 20, 2012
Last Updated: December 3, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Sina Hospital, Iran:
Multiple Sclerosis
MRI Scans

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013