The knowledge obtained from this explorative pilot study will form the basis for hypotheses about pathologic changes in the pain matrix, and emotional and sensory brain areas in women with BII.
ID
Bron
Verkorte titel
Aandoening
breast implant illness
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Structural MRI (including gray matter volume)
Resting-state fMRI (rs-fMRI) intrinsic connectivity of the brain in the resting basal state
Diffusion Tensor Imaging (DTI) Fractional anisotropy (FA)
Achtergrond van het onderzoek
The aim of this pilot study is to explore whether there are structural or functional changes in the brain that can be observed in women with Breast Implant Illness (BII). Furthermore, women with BII will be examined before and after removal of the breast implants, in order the examine if symptoms disappeared.
Study design: In this pilot functional MRI study we will examine six patients diagnosed with Breast Implant Illness (group 1). These patients will undergo an fMRI scan with implants in situ, and six months after removal of their silicone breast implants. Besides, a group of six healthy controls with silicone breast implants will be examined (group 2).
Doel van het onderzoek
The knowledge obtained from this explorative pilot study will form the basis for hypotheses about pathologic changes in the pain matrix, and emotional and sensory brain areas in women with BII.
Onderzoeksopzet
The presence of complaints defined as the typical ASIA manifestations,pain severity, cognitive impairment, grey matter volume, functional connectivity between various brain regions in the pain matrix (namely, thalamus, insular cortex (IC), primary somatosensory cortex (S1), secondary sematosensoty cortex (S2), anterior cingulate cortex (ACC), prefrontal cortex (PFC)) – based on resting state functional MRI, and Fractional anisotropy (FA) are the endpoints of this study.
For the participants in group 1, there will be 2 visits for this study. The first visit will take place whenever the silicone breast implants are still in situ. The second visit will take place 6 months after removal of the silicone breast implants.
There will be one visit for participants in group 2. All visits (group 1 and 2) will be similar.
Onderzoeksproduct en/of interventie
-
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8853 |
| Ander register | METC azM : METC19-089 |