To investigate the effect of explantation of silicone breast implants on neuroimaging of the brain (fMRI) in ASIA syndrome patients to gain more insight in the neurophysiological basis and nociceptive system of ASIA syndrome due to SIIS and the…
ID
Source
Brief title
Condition
- Therapeutic and nontherapeutic effects (excl toxicity)
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
In 2011, Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA-syndrome)
is first described. ASIA-syndrome is a clinical diagnosis with a variety of
clinical manifestations such as fatigue, sleep disturbances, cognitive
impairment (e.g. concentrating problems and/or memory loss), but also
TIA/CVA-like complaints have been described. These complaints are possible due
to 'Silicone Implant Incompatibility Syndrome' (SIIS). The symptoms observed in
ASIA mimic the symptoms of fibromyalgia. Interestingly, however we and others
have documented improvement of symptoms and signs after explantation of the
silicone breast Implants in 50-70% of the patients.
This study aims to investigate the effect of explantation of silicone breast
implants on brain regions involved in the processing of harmless tactile
stimuli in ASIA syndrome patients due to SIIS, with the purpose to reduce or
disappear ASIA syndrome related complaints. This will be the first study to
perform functional MRI scans in ASIA syndrome patients.
Study objective
To investigate the effect of explantation of silicone breast implants on
neuroimaging of the brain (fMRI) in ASIA syndrome patients to gain more insight
in the neurophysiological basis and nociceptive system of ASIA syndrome due to
SIIS and the effect on ASIA complaints.
Study design
This study will be a monocenter exploratory pilot functional MRI study carried
out in the Maastricht University Medical Center (MUMC+).
Intervention
All subjects will undergo an fMRI scan, from which the 4 ASIA syndrome patients
will undergo a fMRI scan twice (pre- and post-explantation).
Study burden and risks
All patients (group 1 and group 2) will undergo two sessions: a diagnostic
session and an functional MRI session, which each will take 1.5 hour of their
time (excl. traveling costs). In total 3 hours will be taken. For the ASIA
syndrome patients this will be 6 hours, because they will undergo the 2
sessions twice (pre- and postexplantation).
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59074.068.16 |