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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01628276
Recruitment Status : Completed
First Posted : June 26, 2012
Last Update Posted : September 12, 2014
Information provided by (Responsible Party):
Mohammad Ali Sahraian, Sina Hospital, Iran

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.

Condition or disease Intervention/treatment Phase
MS (Multiple Sclerosis) Behavioral: Cog Rehab Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Study Start Date : July 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. functional connectivity [ Time Frame: 0, 2nd, 4th Month ]
    Changes in correlation of brain activity in different regions of brain as assessed by Blood Oxygenation Level Dependent (BOLD) signal

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01628276

Iran, Islamic Republic of
Sina Hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Sina Hospital, Iran

Responsible Party: Mohammad Ali Sahraian, Vice President, Sina Hospital, Iran Identifier: NCT01628276     History of Changes
Other Study ID Numbers: MSRC-AE-DCM-1
First Posted: June 26, 2012    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014

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

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