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Neuroimage in patients with Breast Implant Illness (BII), an explorative pilot fMRI-study

Neuroimage in patients with Breast Implant Illness (BII), an explorative pilot fMRI-study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26584
Enrollment
12
Registered
2020-08-25
Start date
2020-08-25
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast implant illness

Interventions

None listed

Sponsors

Maastricht umc
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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)

Secondary

MeasureTime frame
Baseline characteristics: age, BMI, education, occupation, duration of silicone exposure Pain severity, measured with the Chronic Pain Grade. Cognitive impairment, measured with MMSE

Contacts

Public ContactRenée Miseré

MUMC

renee.misere@mumc.nl0612764404

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)