Fatigue in Chronic Pain - Cognition, Emotional Aspects, Biomarkers, and Neuronal Correlates
CompletedNCT05452915
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The investigators will examine mental/cognitive as well as cognitive functions (executive functions, attention functions, processing speed, learning and memory) in 200 patients with chronic pain and 36 healthy controls. Mental fatigue will be measured with questionnaires and cognitive fatigue and cognitive functions with neuropsychological tests. As studies on patients with mild traumatic brain injury has shown that fatigue is associated with altered communication (connectivity) in the brain's attention-related networks, brain connectivity will be measure in 24 patients (women only) and 22 healthy female controls using functional magnetic resonance imaging (fMRI) technology. During the fMRI examination, participants will also perform a 20-minute vigilance task in a scanner. Studies have also shown that inflammatory biomarkers may be related to chronic pain, but inflammatory biomarkers has not been studied in relation to objective measures regarding cognition, fatigue and connectivity changes. Therefore, the patients and controls performing fMRI will also be examined with immunological biomarkers. In addition to this, a further 14 patients and 14 controls carrying out the neuropsychological testing alone will also be examined for immunological biomarkers. The main objectives are: 1. Do patients with chronic pain show more pronounced self-rated mental fatigue and cognitive fatigue compared to healthy controls and are fatigue measures related to cognitive functions such as process speed and attention functions? 2. What is the relationship between cognitive impairments, mental fatigue, or fatigability and 1. the duration of pain 2. generalization of pain and are they affected by covariates, such as sleep disorders and degree of depression/anxiety? 3. Is there an association between immunological biomarkers and cognitive functions/mental fatigue/cognitive fatigability? 4. Does the connectivity in the brain of patients with chronic pain differ from healthy controls at res…
Study details
- Official title
- Fatigue in Chronic Pain - Cognitive Functions, Emotional Aspects, Biomarkers and Neuronal Correlates - a Descriptive Comparative Study
- Interventions
- Diagnostic test: Neuropsychological (NPA)
- Other: Imaging
- Diagnostic test: Inflammatory biomarkers
- Sponsor
- Danderyd Hospital
- Collaborators
- University Hospital, Umeå; Karolinska Institutet; Umeå University; Linkoeping University
- Start date
- 2018-01-01
- Primary completion
- 2022-12-31
- Sex
- All
- Age range
- from 18 Years to 50 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Sweden
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Chronic pain Exclusion Criteria: * Traumatic brain injury (including concussion and mild traumatic brain injury) * Extensive psychiatric problems or substance abuse * Congenital or acquired brain injury and / or does not live in their own home and who needs support in everyday life * Not sufficient knowledge of the Swedish language * Progressive disease * Abuse * Use of drugs with a strong sedative effect * Pregnancy Additional exclusion for Imaging: * Over 45 years of age * Male subjects * Metal objects implanted in the body or metal chips in body parts * Afraid of cramped spaces * Left-handedness
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05452915