Fibromyalgia, Cognitive Rehabilitation Software

NCT07010172 | Not Yet Recruiting

• 1 other identifier: E-79735520-799
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• Stroop Colour and Word Test

  start and first month

• Number Range Test

  start and first month

Secondary Outcomes (1)

• modified Fibromyalgia impact questionnaire

  start and first month

Study Arms (1)

cognitive rehabilitation software

EXPERIMENTAL

3-5 sessions per week, 4 weeks cognitive rehabilitation with computer software

Device: cognitive rehabilitation with computer software

Interventions

cognitive rehabilitation with computer software DEVICE

3-5 sessions per week, 4 weeks cognitive rehabilitation with computer software

cognitive rehabilitation software

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a woman
• Diagnosed with fibromyalgia
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Savaş Karpuz: lead

MeSH Terms

Conditions

Fibromyalgia

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: June 8, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share