FibromyalgiaNCT00789178
Cognitive and Memory Function in Patients With Fibromyalgia
An observational study of Fibromyalgia and Cognitive Impairment, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Patients suffering from Fibromyalgia will be examined for the presence of memory and/or cognitive impairment using specific psychological tests. Their results will be compared to those with active RA associated with pain and with a normal control group. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Cognitive Impairment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2008to Apr 2010
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 patients with fibromyalgia 30 patients with RA 20 healthy controls
Who may be able to join
- Patients suffering from fibromyalgia patients suffering from active RA
Who cannot join
- Patients with depressive disorders Patients treated with SSRI
Trial locations and contacts
1 site in 1 country.
Israel1 site
Asaf Harofe Medical Center
Zrifin, 70300
Anat Alon, BA, 97289779263
About this study
Official title: Cognitive and Memory Function in Patients With Fibromyalgia and Their Influence on Disability
Patients suffering from Fibromyalgia will be examined for the presence of memory and/or cognitive impairment using specific psychological tests.
Their results will be compared to those with active RA associated with pain and with a normal control group.
- Conditions
- Fibromyalgia, Cognitive Impairment
- Keywords
- memory disturbances
- Medical subject headings
- Fibromyalgia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with fibromyalgia | Not described | |
| patients with active RA | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionOct 2009 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789178
- Sponsor's protocol ID
- 154/08
- Status last verified
- Nov 2008
- First submitted
- 9 Nov 2008
- Last updated
- 11 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Memory Function in Patients With Fibromyalgia and Their Influence on Disability
- ClinicalTrials.gov ID
- NCT00789178
- Acronym / sponsor ID
- 154/08
- Conditions
- Fibromyalgia, Cognitive Impairment
- Keywords
- memory disturbances
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Dec 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 11 Nov 2008 (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.
Patients suffering from Fibromyalgia will be examined for the presence of memory and/or cognitive impairment using specific psychological tests.
Their results will be compared to those with active RA associated with pain and with a normal control group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with fibromyalgia | – | – |
| patients with active RA | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients with fibromyalgia 30 patients with RA 20 healthy controls
Key inclusion criteria (1 listed)
- Patients suffering from fibromyalgia patients suffering from active RA
Key exclusion criteria (1 listed)
- Patients with depressive disorders Patients treated with SSRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2008.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Cognitive Impairment, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Nov 2008. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moshe Tishler, MD (97289779262, tishler@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 11 Nov 2008.