This study aims to evaluate the frontostriatal cognitive functioning and the functional connectivity in 15 HIV-negative participants using BOLD fMRI.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cognitieve aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Brain activation measured with BOLD fMRI when performing specified tasks
Secondary outcome
Brain activation measured with BOLD fMRI when performing an inhibition task
Brain activation measured with BOLD fMRI when performing a reward task
Brain connectivity measured with BOLD fMRI during resting state
Background summary
HIV Associated Neurocognitive Disorders (HAND) are a frequent and important
comorbidity of HIV-infection. The pathogenesis of this disorder is still not
clear. BOLD fMRI is a sensitive and patient-friendly research tool to
investigate cognitive functioning, and can aid in unravelling the origins of
neurocognitive decline in HIV patients. In the ESCAPE study (METC-no 15/141),
we performed fMRI on 40 HIV-positive patients switching combination
antiretroviral therapy (cART) comparing them to 20 HIV+ controls. Preliminary
results show an effect of cART on cognition. To further unravel these effects
and investigate whether HIV infection itself also has an effect, comparing the
ESCAPE-results with HIV-uninfected controls will strengthen the outcomes
immensely. In fMRI research, it is important to use valid methodology and
standardized tasks and equipment, and in HIV research, it is important to use a
highly comparable control group. Therefore the proposal of the SHERLOC-study
will precisely mimic the previously approved ESCAPE-study, in its study design
and execution.
Study objective
This study aims to evaluate the frontostriatal cognitive functioning and the
functional connectivity in 15 HIV-negative participants using BOLD fMRI.
Study design
observational longitudinal study
Study burden and risks
participants in the SHERLOC study will be asked to come to the hospital for a
total of 3 visits, screening, baseline and week 12 (end of study). At
screening, blood will be drawn to test for thyroid or liver pathology. At
baseline and week 12, participants will undergo a functional MRI scan, with an
average duration of 50 minutes. Measures will be taken to ensure the
participant is safe and comfortable in the scanner. When appropriate safety
measures are used, MRI is a proven safe diagnostic procedure. There is not a
group related benefit for this population. However, information about this
population will aid in unravelling the effects of HIV compared to cART in
relation to development of HAND.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Male, between 25 and 50 years
- HIV-negative at screening visit
- Negative TPHA or VDRL < 12 months prior to or at screening visit
- No signs of an acute or chronic hepatitis C infection within the past 12 months before screening as defined in the Dutch guideline
- No subjective neurocognitive complaints in the preceding 12 months
- Consent to using anonymous patient file
- Able to understand an comply to study procedures and to provide written informed consent
Exclusion criteria
- Proven major depression through psychiatric consultation within the past year or on anti-depressant drugs
- History of proven neurologic disease (e.g. multiple scleroses, brain tumour, cerebrovascular event, etc.)
- Active psychiatric disorders classified according to the DSM V criteria
- History or evidence of alcohol or drug abuse according to the DSM V criteria
- TSH not within normal reference values
- Contraindications for undergoing an MRI according to standard UMCU MRI protocol; a pacemaker or metallic device in situ, proven claustrophobia.
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 | NL59537.041.16 |