Clinical trial NCT03956771: Neurofeedback for Treatment-resistant Obsessive-compulsive Disorder (OCD)
Official title: Neurofeedback With Magnetic Resonance Imaging (MRI) for OCD Participants With Treatment-resistance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obsessive-Compulsive Disorder
OCD
Keywords: neurofeedback
biofeedback
OCD
obsessive-compulsive disorder
magnetic resonance imaging
functional magnetic resonance imaging
orbitofrontal cortex
Lead sponsor: University of Minho
Sponsor class: OTHER
Collaborators: name: Hospital de Braga
name: Clinical Academic Center (2CA)
First posted: 2019-05-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: OCD participants will be blindly split into two groups (n = 15): the real neurofeedback group (group 1, experimental group) and the sham neurofeedback group (group 2, sham comparator control group). Group 1 will receive feedback information from real activity from the target brain region, while group 2 will receive false feedback not matching real brain responses to account for placebo effects (from other participant's data).
Primary purpose: TREATMENT

Brief summary: The aim of this study is to teach participants with a OCD diagnosis and treatment-resistance how to decrease the response from a brain region involved in the disease by using a technique called neurofeedback. While using this technique, the participants visualize their own brain response in a screen during a MRI exam. Participants will learn strategies to decrease brain responses. The neurofeedback technique is non-invasive, without known risks to participants. With this study, it is expect that the neurofeedback training over 2 weeks (2 sessions) will reduce the OCD symptoms when compared to a control intervention based on neurofeedback's placebo effects.

Detailed description: OCD individuals will be recruited at Hospital of Braga, Braga, Portugal, in collaboration with the Psychiatry Unit (n = 30, nonrandom convenience sample based on effect size of 0.30, alpha = beta = 0.05, and ANOVA repeated measures within-between interaction). Some participants may quit the study but sample size was predetermined considering a putative 30 percent dropout rate. Clinical history will be assessed (sociodemographic information, disease onset and severity, and previous/current treatments). The participants' neuropsychological state, the blood hormonal levels, and brain function and structure as baseline measures before and after the neurofeedback intervention will be assessed. Two MRI neurofeedback sessions will be performed during 2 weeks (2 distinct days; 36 min per session) in a 3 T MRI scanner. Data analysis will be performed with a repeated measures design (baseline and after neurofeedback) between the groups to measure brain, blood, and neuropsychological changes. Patients will be supervised by a physician to track putative complications/adverse effects during the intervention. The participation will be immediately interrupted in case of adverse reactions or symptomatic worsening and a physician will follow the participants to provide the appropriated care.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of current OCD according to the fifth Diagnostic and Statistical Manual of Mental Disorders;
* Treatment resistance (≥ 3 selective serotonin reuptake inhibitors in proper dose for ≥ 12 weeks).

Exclusion Criteria:

* Concomitant psychiatric or neurological illness;
* Substance abuse/dependence in the past 6 months (except nicotine/caffeine);
* Acute suicidal ideation;
* Psychotropic medication (except selective serotonin reuptake inhibitors, anafranil, or low-dose hypnotic or anxiolytic taken occasionally);
* MRI contraindications (pregnancy, major head trauma, severe claustrophobia, severe back pain, ferromagnetic materials/prostheses/implants inside the body, or other).

Primary outcomes:
measure: Mean change from baseline in Yale-Brown Obsessive Compulsive Scale score.
timeFrame: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
measure: Mean change from baseline in Obsessive-Compulsive Inventory-Revised score.
timeFrame: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
measure: Mean change from baseline in Hamilton Anxiety Rating Scale score.
timeFrame: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
measure: Mean change from baseline in Hamilton Depression Rating Scale score.
timeFrame: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
measure: Mean change from baseline in State-Trait Anxiety Inventory score.
timeFrame: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
measure: Mean change from baseline in the score of Perceived Stress Scale with 10 items.
timeFrame: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
measure: Mean change from baseline in Emotion Regulation Questionnaire score.
timeFrame: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
Secondary outcomes:
measure: Difference from baseline in functional connectivity patterns in the brain.
timeFrame: 2-3 days before the intervention, 2-3 days after the intervention
measure: Differences from baseline in brain grey and white matter structure.
timeFrame: 2-3 days before the intervention, 2-3 days after the intervention
measure: Mean change from baseline in blood hormonal composition
timeFrame: 2-3 days before the intervention, 2-3 days after the intervention
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Life and Health Sciences Research Institute, School of Medicine, University of Minho
state: Gualtar
Study officials:
affiliation: Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho; ICVS/3B's - PT Government Associate Laboratory; Braga, Portugal
name: Pedro Morgado, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: