euroimage in patients with Breast Implant Illness (BII), an explorative pilot fMRI-study
Recruiting
- Conditions
- breast implant illness
- Registration Number
- NL-OMON26584
- Lead Sponsor
- Maastricht umc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
• Age: 25 to 76 years old
• Diagnosis of ASIA-syndrome vs. no complaints
• No diagnosis of a chronic pain syndrome,
fibromyalgia (FM) or chronic fatigue
syndrome (CFS).
• Silicone filled breast implants
• Cosmetic purpose of silicone breast implants
• Cognitive impairment and/or memory
disturbances1
• Competent patients
Exclusion Criteria
• Cancer
• Diabetes Mellitus
• Claustrophobia or fear of being in a closed space
• Neuropathy of the upper or lower extremities
• Medication2: antidepressants, any analgesics,
anticonvulsants, muscle relaxants or benzodiazepines
• MRI incompatible health condition (i.e., ICD,
pacemaker or other metal prosthetic implants)
• History of CVA/TIA
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method