MS (Multiple Sclerosis)NCT01628276
Brain Functional Connectivity Changes Following Cognitive Rehabilitation in Multiple Sclerosis: an fMRI Study
A study testing Cog Rehab in people with MS (Multiple Sclerosis), run by Sina Hospital, Iran at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- MS (Multiple Sclerosis)
- What is being tested?
- Cog Rehab
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIran
- Study dates
- Jul 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Definitive MS diagnosis
- Right handedness
- EDSS 0-4
- No relapse in past 6 weeks
- Willing to consent and participate in the study
Who cannot join
- Pregnancy
- Left handedness
- Neurologic or psychiatric disorder other than MS
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- MS (Multiple Sclerosis)
- Being tested
- Cog Rehab
- Keywords
- Multiple Sclerosis, MRI Scans
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cog RehabBehavioural
Cognitive rehab for MS patients
| Study group | Role | What they receive |
|---|---|---|
| Rehab first | Experimental | Not described Receives: Behavioral: Cog Rehab |
| Rehab Second | Experimental | Not described Receives: Behavioral: Cog Rehab |
| Non Rehab | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional connectivity
Changes in correlation of brain activity in different regions of brain as assessed by Blood Oxygenation Level Dependent (BOLD) signal
Measured: 0, 2nd, 4th Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MS (Multiple Sclerosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sina Hospital, Iran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Ali Sahraian, Sina Hospital, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628276
- Sponsor's protocol ID
- MSRC-AE-DCM-1
- Status last verified
- Sep 2014
- First submitted
- 20 Jun 2012
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Functional Connectivity Changes Following Cognitive Rehabilitation in Multiple Sclerosis: an fMRI Study
- ClinicalTrials.gov ID
- NCT01628276
- Acronym / sponsor ID
- MSRC-AE-DCM-1
- Conditions
- MS (Multiple Sclerosis)
- Keywords
- Multiple Sclerosis, MRI Scans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sina Hospital, IranUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rehab first | Experimental | Behavioral: Cog Rehab |
| Rehab Second | Experimental | Behavioral: Cog Rehab |
| Non Rehab | No intervention | – |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Definitive MS diagnosis
- Right handedness
- EDSS 0-4
- No relapse in past 6 weeks
- Willing to consent and participate in the study
Key exclusion criteria (3 listed)
- Pregnancy
- Left handedness
- Neurologic or psychiatric disorder other than MS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cog RehabCognitive rehab for MS patients | Behavioural | Rehab Second, Rehab first |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cog Rehab in people with MS (Multiple Sclerosis), run by Sina Hospital, Iran at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional connectivity (time frame: 0, 2nd, 4th Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2014.