The central objective is to explore the functional connectivity profiles of both STN and VS circuits during cognitive and affective tasks and compare these between OCD patients and healthy controls (HC). Secondary objectives are to assess…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes for this study are the functional connectivity profiles of
the STN and the VS from each group during the cognitive and affective tasks,
measured with BOLD-fMRI.
Secondary outcome
The secondary outcomes for this study are the answers on the Y-BOCS, MADRS,
STAI and POMS questionnaires. Other secondary outcomes are the performance on
the (computer) tasks (Trail Making and Emotional-Stroop) and MRI tasks,
described by the reaction time and accuracy rating scores.
Background summary
Obsessive-compulsive disorder (OCD) is a severe disorder, affecting around 1%
to 3% of the general population. It is characterized by repeated and
heterogenious obsessions and/or compulsions. Cognitive behavior therapy (CBT)
and drug treatment are first-line treatment options. Unfortunately, up to 10%
to 20% of the patients do not respond to these interventions and become
candidates for deep brain stimulation (DBS). In OCD, DBS usually targets the
cortico-basal ganglia-thalamocortical system with key areas being the
subthalamic nucleus (STN) and ventral striatum (VS; i.e., the nucleus
accumbens, ventral capsule, and partially the BNST). Despite the comparable
efficacy of these structures, studies indicate only a 30% to 40% symptom
improvement. This is a lower rate compared to DBS in movement disorders.
However, OCD is a heterogeneous disease. Further, prior research revealed
functional differentiated brain networks and ascribes a more cognitive and
affective processing role for the STN and VS, respectively. We, thus,
hypothesize that DBS response in OCD is associated with distinct functional
connectivity profiles of the VS and the STN, respectively. Studying functional
connectivity in OCD patients without DBS provides a baseline understanding of
neural networks associated with the disorder. This baseline serves as a
reference point for evaluating the effects of DBS on functional connectivity
and elucidating its therapeutic mechanisms.
Study objective
The central objective is to explore the functional connectivity profiles of
both STN and VS circuits during cognitive and affective tasks and compare these
between OCD patients and healthy controls (HC). Secondary objectives are to
assess associations between symptom severity and cognitive and affective
functioning in OCD.
Study design
The research design will be a matched case-control study, including healthy
controls and OCD patients. All participants will take part in an inclusion
meeting (pre-session) to examine participation eligibility. If eligible, they
will undergo a 3T scanning session assessing structural and functional
connectivity of the STN and VS. During the functional scan, all participants
will be scanned at rest and while performing a cognitive, an affective and a
combined cognitive-affective task.
Intervention
The present research will incorporate existing OCD DBS patients and OCD DBS
candidates. For both groups, DBS has been/will be implanted as part of their
treatment plan, not for the purpose of the present research. DBS effects will
be investigated during ON and OFF stimulation (existing OCD DBS patients) and
pre- and post-surgery (OCD DBS candidates).
Study burden and risks
Participants may experience little discomfort during the (f)MRI scan. Such
discomfort may include dizziness, nausea, and claustrophobia. All participants
will fill out questionnaires to assess for MRI-safety, neuropsychological
functioning, symptom severity, anxiety and mood, which in total should not take
up more than one hour of their time. All participants will then be scanned
(anatomical and functional scan) for approximately 2 hours. The total duration
of participation will be no longer than 3 hours.
Although no immediate or direct benefit arise when taking part in the current
study for either healthy volunteers or OCD patients, their involvement could
assist in establishing fundamental insight into action mechanisms of OCD.
Ultimately, it will provide a basis for tailored DBS-targets based on the
complaints of individual patients.
Vijverdalseweg 1
Maastricht 6226 NB
NL
Vijverdalseweg 1
Maastricht 6226 NB
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for HC:
- The subject provides written informed consent attesting to their
understanding of the study's objectives and the procedures involved, as well as
their willingness to participate.
- The volunteer is healthy, i.e. absence of all exclusion criteria
- Age between 18-65 years old
Inclusion criteria for OCD patients:
- Clinical diagnosis of OCD
- The subject provides written informed consent attesting to their
understanding of the study's objectives and the procedures involved, as well as
their willingness to participate.
- Absence of all exclusion criteria for OCD patients
- Age between 18-65 years old
Exclusion criteria
Exclusion criteria for HC:
- Current psychiatric/neurological diagnosis
- History of psychiatric treatment
- Current use of psychoactive medication
- Standard contra-indications for magnetic resonance imaging
- Current substance abuse (e.g. (excessive) use of drugs or alcohol)
Exclusion criteria for OCD patients:
- Current substance abuse (e.g. excessive use of drugs or alcohol)
- Standard contra-indications for magnetic resonance imaging
Design
Recruitment
Medical products/devices used
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 | NL86150.068.24 |