The effect of explantation of silicone breast implants on neuroimages of the brain in ASIA-syndrome patients: a pilot fMRI-study<br>
- Conditions
- 1006291510042258ASIA-syndrome due to SIIS
- Registration Number
- NL-OMON45422
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 9
ASIA-patients (group 1):
- Gender: female adults
- Age: 25 to 76 years old
- Diagnosis of ASIA-syndrome
- 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 disturbances;Healthy control patients (group 2):
- Gender: female adults
- Matched for gender and implant duration
- Healthy (no diagnosis of ASIA-syndrome, a chronic pain syndrome, fibromyalgia (FM) or chronic fatigue syndrome (CFS))
- Silicone filled breast implants
- Cosmetic purpose of silicone breast implants
- No complaints of cognitive impairment and/or memory disturbances
ASIA-patients (group 1):
- Pregnancy
- Cancer
- Diabetes Mellitus
- Claustrophobia or fear of being in a closed space
- Neuropathy of the upper or lower extremities
- Medication: antidepressants, any analgesics, anticonvulsants, muscle relaxants or benzodiazepines
- MRI incompatible health condition (i.e., ICD, pacemaker or other metal prosthetic implants)
- Neurological manifestations (CVA/TIA-like complaints);Healthy control patients (group 2):
- Pregnancy
- Cancer
- Diabetes Mellitus
- Medication: antidepressants, any analgesics, anticonvulsants, muscle relaxants or benzodiazepines
- MRI incompatible health condition (i.e., ICD, pacemaker or other metal prosthetic implants)
- Neurological manifestations (CVA/TIA-like complaints)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1) Blood oxygenation level dependent (BOLD) respons (fMRI): a) during tactile<br /><br>stimulation, b) at rest;<br /><br>2) Fractional anisotropy (FA) of water diffusivity;<br /><br>3) Tactile discrimination thresholds in mm.</p><br>
- Secondary Outcome Measures
Name Time Method <p>4) The presence of complaints defined as the typical ASIA manifestations (the<br /><br>2010 ACR-criteria for fibromyalgia);<br /><br>5) Pain scores (Visual Analog Scale; VAS 0-10);<br /><br>6) Pain-related fear (Tampa Scale for Kinesiophobia and/or PASS-20);<br /><br>7) Catastrophic thinking (Pain Catastrophizing Scale; PCS);<br /><br>8) Baseline characteristics: gender, age, cultural background, marital status,<br /><br>level of education, profession, work situation.</p><br>