NCT01628276

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 26, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

1.2 years

First QC Date

June 20, 2012

Last Update Submit

September 11, 2014

Conditions

MS (Multiple Sclerosis)

Keywords

Multiple SclerosisMRI Scans

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Rehab first

EXPERIMENTAL
Behavioral: Cog Rehab

Rehab Second

EXPERIMENTAL
Behavioral: Cog Rehab

Non Rehab

NO INTERVENTION

Interventions

Cog RehabBEHAVIORAL

Cognitive rehab for MS patients

Rehab SecondRehab first

Eligibility Criteria

Age18 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Left handedness
  • Neurologic or psychiatric disorder other than MS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sina Hospital

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President

Study Record Dates

First Submitted

June 20, 2012

First Posted

June 26, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations

IR(1)