ASIA-syndrome due to SIIS
Conditions
Interventions
fMRI
All subjects will undergo an fMRI scan, from which the 4 ASIA syndrome patients
will undergo a fMRI scan twice (pre- and post-explantation).
ASIA-syndrome
Silicone breast implants
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Blood oxygenation level dependent (BOLD) respons (fMRI): a) during tactile stimulation, b) at rest; 2) Fractional anisotropy (FA) of water diffusivity; 3) Tactile discrimination thresholds in mm. | — |
Secondary
| Measure | Time frame |
|---|---|
| 4) The presence of complaints defined as the typical ASIA manifestations (the 2010 ACR-criteria for fibromyalgia); 5) Pain scores (Visual Analog Scale; VAS 0-10); 6) Pain-related fear (Tampa Scale for Kinesiophobia and/or PASS-20); 7) Catastrophic thinking (Pain Catastrophizing Scale; PCS); 8) Baseline characteristics: gender, age, cultural background, marital status, level of education, profession, work situation. | — |
Countries
The Netherlands
Outcome results
None listed