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 - Neuroimage in Breast Implant Illness

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55243

Enrollment

Registered

2020-04-21

Start date

2020-08-12

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

pijnregulatie ASIA-syndrome breast implant illness

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age: 18 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 (group 1) explanted (group 2) Cosmetic purpose of silicone breast implants Cognitive impairment and/or memory disturbances Competent patients Controles: Age: 18 to 76 years old Matched for 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 Competent patients

Exclusion criteria

Exclusion criteria: Cancer Diabetes Mellitus Claustrophobia or fear of being in a closed space Medication (>6 months): antidepressants, any analgesics, anticonvulsants, benzodiazepines MRI incompatible health condition (i.e., ICD,pacemaker or other metal prosthetic implants) History of CVA/TIA

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints: 1. The presence of complaints defined as the typical ASIA manifestations (table 1);	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints 1. Baseline characteristics: age, BMI, education, occupation, duration of silicone exposure 2. Pain severity, measured with the Chronic Pain Grade 31. 3. Cognitive impairment, measured with MMSE 32 4. Structural MRI (including gray matter volume) 5. Psychosocial health, measured with 4DKL 6. Resting-state fMRI (rs-fMRI) - intrinsic connectivity of the brain in the resting basal state 7. Diffusion Tensor Imaging (DTI) - Fractional anisotropy (FA)	—

Measure

Time frame

Secondary study parameters/endpoints 1. Baseline characteristics: age, BMI, education, occupation, duration of silicone exposure 2. Pain severity, measured with the Chronic Pain Grade 31. 3. Cognitive impairment, measured with MMSE 32 4. Structural MRI (including gray matter volume) 5. Psychosocial health, measured with 4DKL 6. Resting-state fMRI (rs-fMRI) - intrinsic connectivity of the brain in the resting basal state 7. Diffusion Tensor Imaging (DTI) - Fractional anisotropy (FA)

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Countries

Netherlands

Outcome results