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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohammad Ali Sahraian, Sina Hospital, Iran
ClinicalTrials.gov Identifier:
NCT01628276
First received: June 20, 2012
Last updated: September 11, 2014
Last verified: September 2014
  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:


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


Enrollment: 45
Study Start Date: July 2012
Study Completion Date: October 2013
Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628276

Locations
Iran, Islamic Republic of
Sina Hospital
Tehran, Iran, Islamic Republic of
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: September 11, 2014
Health Authority: Iran: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 27, 2014