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

Completed

Conditions: pijnregulatie
ASIA-syndrome
breast implant illness
10003816
10009841

Registration Number: NL-OMON55243

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 36

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

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints:<br /><br>1. The presence of complaints defined as the typical ASIA manifestations (table<br /><br>1);</p><br>

Secondary Outcome Measures

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