FibromyalgiaNCT07010172
Fibromyalgia, Cognitive Rehabilitation Software
A study testing cognitive rehabilitation with computer software in people with Fibromyalgia and Cognitive Rehabilitation, run by Savaş Karpuz.
Trial summary
In recent years, especially in developed countries, FMS has emerged as a serious social problem by decreasing labour force and quality of life. Especially clinicians have started to consider cognitive dysfunction in FMS as a separate clinical condition. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia, Cognitive Rehabilitation
- What is being tested?
- cognitive rehabilitation with computer software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being a woman
- Diagnosed with fibromyalgia
- 18-65 years old
Who cannot join
- concomitant neurological disorder, learning disorder or cognitive impairment
- current alcohol or recreational drug dependence or long-term (≥5 years) history of substance abuse
- visual or hearing impairment that would interfere with cognitive testing
- diagnosis of untreated obstructive sleep apnoea,
- atypical sleep/wake patterns (e.g. night shift workers)
- Lack of computer and internet access
About this study
Official title: Effectiveness of Cognitive Rehabilitation Software in Female Patients With Fibromyalgia
In recent years, especially in developed countries, FMS has emerged as a serious social problem by decreasing labour force and quality of life. Especially clinicians have started to consider cognitive dysfunction in FMS as a separate clinical condition. In the light of the data obtained, can say that cognitive dysfunction increases in the presence of depression, anxiety, sleep disorders, endocrine imbalances and pain.
Neuroscience and technological advances make it possible to meet the demand for care and improve the quality of stimulation by enabling the automation of many cognitive training procedures, improving patient record reliability and optimising performance of disability functions. The recently implemented RehaCom and HeadApp programmes (Schuhfried, Austria). excellent results have been reported in clinical practice with no significant adverse effects.
This study will investigate the effectiveness of a cognitive rehabilitation programme using computer software in female patients with fibromyalgia.
- Conditions
- Fibromyalgia, Cognitive Rehabilitation
- Being tested
- cognitive rehabilitation with computer software
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive rehabilitation with computer softwareDevice
3-5 sessions per week, 4 weeks cognitive rehabilitation with computer software
| Study group | Role | What they receive |
|---|---|---|
| cognitive rehabilitation software | Experimental | 3-5 sessions per week, 4 weeks cognitive rehabilitation with computer software Receives: Device: cognitive rehabilitation with computer software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop Colour and Word Test
Measured: start and first month
Number Range Test
Measured: start and first month
Secondary outcomes (1)
modified Fibromyalgia impact questionnaire
Measured: start and first month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Savaş Karpuz
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Savaş Karpuz, Konya Beyhekim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010172
- Sponsor's protocol ID
- E-79735520-799
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cognitive Rehabilitation Software in Female Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07010172
- Acronym / sponsor ID
- E-79735520-799
- Conditions
- Fibromyalgia, Cognitive Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Savaş KarpuzOther government
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 8 Jun 2025 (actual)
- 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.
In recent years, especially in developed countries, FMS has emerged as a serious social problem by decreasing labour force and quality of life. Especially clinicians have started to consider cognitive dysfunction in FMS as a separate clinical condition. In the light of the data obtained, can say that cognitive dysfunction increases in the presence of depression, anxiety, sleep disorders, endocrine imbalances and pain.
Neuroscience and technological advances make it possible to meet the demand for care and improve the quality of stimulation by enabling the automation of many cognitive training procedures, improving patient record reliability and optimising performance of disability functions. The recently implemented RehaCom and HeadApp programmes (Schuhfried, Austria). excellent results have been reported in clinical practice with no significant adverse effects.
This study will investigate the effectiveness of a cognitive rehabilitation programme using computer software in female patients with fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cognitive rehabilitation software | Experimental | Device: cognitive rehabilitation with computer software3-5 sessions per week, 4 weeks cognitive rehabilitation with computer software |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being a woman
- Diagnosed with fibromyalgia
- 18-65 years old
Key exclusion criteria (6 listed)
- concomitant neurological disorder, learning disorder or cognitive impairment
- current alcohol or recreational drug dependence or long-term (≥5 years) history of substance abuse
- visual or hearing impairment that would interfere with cognitive testing
- diagnosis of untreated obstructive sleep apnoea,
- atypical sleep/wake patterns (e.g. night shift workers)
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 |
|---|---|---|
| cognitive rehabilitation with computer software3-5 sessions per week, 4 weeks cognitive rehabilitation with computer software | Device | cognitive rehabilitation software |
Primary outcome
Stroop Colour and Word Test
Time frame: start and first month
Number Range Test
Time frame: start and first month
1 secondary outcome
modified Fibromyalgia impact questionnaire
Time frame: start and first month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive rehabilitation with computer software in people with Fibromyalgia and Cognitive Rehabilitation, run by Savaş Karpuz.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Stroop Colour and Word Test (time frame: start and first month). The study lists 2 primary outcomes in all. 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 8 Jun 2025.