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

• Sponsor: Sina Hospital, Iran (Other)
• Overall Status: Completed
• CT.gov ID: NCT01628276
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 3
• Duration (Months): 15
• Patients Per Site Per Month: 3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. functional connectivity [0, 2nd, 4th Month]

   Changes in correlation of brain activity in different regions of brain as assessed by Blood Oxygenation Level Dependent (BOLD) signal

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 54 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sina Hospital	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

• Sina Hospital, Iran

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammad Ali Sahraian, Vice President, Sina Hospital, Iran
• ClinicalTrials.gov Identifier: NCT01628276
• Other Study ID Numbers: MSRC-AE-DCM-1
• First Posted: Jun 26, 2012
• Last Update Posted: Sep 12, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Mohammad Ali Sahraian, Vice President, Sina Hospital, Iran: Multiple Sclerosis; MRI Scans
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis

Study Results

No Results Posted as of Sep 12, 2014